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The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System using Radiostereometric Analysis (RSA), and to assess the long-term safety and effectiveness of the study device. This study will document any device-related surgical or post-operative complications and adverse radiographic observations.
Subjects meeting the entrance criteria specified in this protocol will be randomized as they become available.
The purpose of the current investigation is to compare migration of the device after implantation with a modular, short hip stem called the "MIS Stem" or a standard THA using the Synergy Hip System using RSA. The intended use of this product is for patients with inflammatory and non-inflammatory degenerative joint disease who require a primary total hip replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIS Femoral Neck Stem | Subject will be randomized to either MIS or Synergy implant. |
| |
| Synergy Hip System | Subject will be randomized to either Synergy or MIS implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIS Femoral Neck Stem implant | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) | Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System. | Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported |
| Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement) | Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System. | Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. |
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Inclusion Criteria:
Exclusion Criteria:
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The purpose of the current investigation is to compare migration of the device after implantation with a modular, short hip stem called the "MIS Stem" or a standard THA using the Synergy Hip System using RSA. The intended use of this product is for patients with inflammatory and non-inflammatory degenerative joint disease who require a primary total hip replacement.
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| Name | Affiliation | Role |
|---|---|---|
| Richard McCalden, MD | London Health Science Center | Principal Investigator |
| Beate Hanson, MD, PhD | Vice President, Global Clinical Strategy and Global Clinical Operations | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Center- University Hospital | London | Ontario | N6A 5A5 | Canada |
Preoperative evaluation was conducted following signing of the ICF but prior to randomization. A total of 41 subjects had surgery for either MIS Stem or Synergy implantation.
Subjects were enrolled by 1 investigator in Canada. The study period was from 30 Jun 2009 to 22 Apr 2016.
| ID | Title | Description |
|---|---|---|
| FG000 | MIS Femoral Neck Stem | Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options. |
| FG001 | Synergy Hip System | Standard total hip arthroplasty (THA) using total hip system. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
43 hips were randomized into the study, with 2 hips excluded, resulting in a total of 41 hips (4 bilateral hips) enrolled in the study - 20 Synergy hips and 21 MIS Stem hips
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| ID | Title | Description |
|---|---|---|
| BG000 | MIS Femoral Neck Stem | Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) | Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System. | Statistical comparisons were done using data from hips with all with RSA information at 2 years (20 MIS and 18 Synergy). | Posted | Mean | Full Range | mm | Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported |
|
From signed consent to the completion of the study at the 5-year follow-up visit, or early termination/subject withdrawal, whichever came first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MIS Femoral Neck Stem | Designed to minimize the removal of bone from the femoral canal and the proximal neck. Along with a shortened length, the femoral stem uses a modular neck that allows for optimizing the offset angle to allow customization during surgery to better fit each patient. The modular neck features a standard taper consistent with various head options. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loose femoral stem | Product Issues | Proprietary system | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial wound infection | Infections and infestations | Proprietary system | Systematic Assessment |
There was a decreased compliance rate at the 3-year follow-up visit and an increased termination rate by the 5-year follow-up visit resulting in smaller sample sizes for data collection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracey Brengola, MS | Smith & Nephew, Inc | 978-749-1491 | Tracey.brengola@smith-nephew.com |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Preoperative |
| 3 Months Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | 3 months postoperative |
| 1 Year Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | 1 year postoperative |
| 2 Years Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | 2 years postoperative |
| 3 Years Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | 3 years postoperative |
| 5 Years Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | 5 years postoperative |
| Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | Preoperative |
| 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | 3 months postoperative |
| 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | 1 year postoperative |
| 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | 2 years postoperative |
| 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | 3 years postoperative |
| 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | 5 years postoperative |
| Preoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Preoperative |
| 3 Months Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 3 months postoperative |
| 1 Year Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 1 year postoperative |
| 2 Years Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 2 years postoperative |
| 3 Years Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 3 years postoperative |
| 5 Years Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 5 years postoperative |
| Withdrawal by Subject |
|
| Revision due to femoral stem loosening |
|
| Revision due to dislocation |
|
| Death |
|
| BG001 |
| Synergy Hip System |
Standard total hip arthroplasty (THA) using total hip system. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Primary Diagnosis: Charnley Classification | Count of Participants | Participants |
|
| OG001 | Synergy Hip System | Standard total hip arthroplasty (THA) using total hip system. |
|
|
| Secondary | Preoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | Data from hips with all with RSA information at pre-operative visit (21 MIS and 20 Synergy). | Posted | Count of Participants | Participants | Preoperative |
|
|
|
| Secondary | 3 Months Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | Data from hips with all with RSA information at 3 months (19 MIS and 16 Synergy). | Posted | Count of Participants | Participants | 3 months postoperative |
|
|
|
| Secondary | 1 Year Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | Data from hips with all with RSA information at 1 year (21 MIS and 15 Synergy). | Posted | Count of Participants | Participants | 1 year postoperative |
|
|
|
| Secondary | 2 Years Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | Data from hips with all with RSA information at 2 years (21 MIS and 16 Synergy). | Posted | Count of Participants | Participants | 2 years postoperative |
|
|
|
| Secondary | 3 Years Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | Data from hips with all with RSA information at 3 years (15 MIS and 13 Synergy). | Posted | Count of Participants | Participants | 3 years postoperative |
|
|
|
| Secondary | 5 Years Postoperative Total Harris Hip Score (HHS) | The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject. | Data from hips with all with RSA information at 5 years (17 MIS and 12 Synergy). | Posted | Count of Participants | Participants | 5 years postoperative |
|
|
|
| Secondary | Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | Data from hips with all with RSA information at pre-operative visit (21 MIS and 20 Synergy). | Posted | Mean | Standard Deviation | score on a scale | Preoperative |
|
|
|
| Secondary | 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | Data from hips with all with RSA information at 3 months (19 MIS and 16 Synergy). | Posted | Mean | Standard Deviation | score on a scale | 3 months postoperative |
|
|
|
| Secondary | 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | Data from hips with all with RSA information at 1 year (21 MIS and 15 Synergy). | Posted | Mean | Standard Deviation | score on a scale | 1 year postoperative |
|
|
|
| Secondary | 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | Data from hips with all with RSA information at 2 years (21 MIS and 16 Synergy). | Posted | Mean | Standard Deviation | score on a scale | 2 years postoperative |
|
|
|
| Secondary | 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | Data from hips with all with RSA information at 3 years (15 MIS and 13 Synergy). | Posted | Mean | Standard Deviation | score on a scale | 3 years postoperative |
|
|
|
| Secondary | 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life. Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms. | Data from hips with all with RSA information at 3 years (17 MIS and 12 Synergy). | Posted | Mean | Standard Deviation | score on a scale | 5 years postoperative |
|
|
|
| Secondary | Preoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Data from all enrolled hips who received a study device (21 MIS and 20 Synergy). | Posted | Count of Participants | Participants | Preoperative |
|
|
|
| Secondary | 3 Months Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Data from hips with all with RSA information at 3 months (19 MIS and 16 Synergy). | Posted | Count of Participants | Participants | 3 months postoperative |
|
|
|
| Secondary | 1 Year Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Data from hips with all with RSA information at 1 year (20 MIS and 15 Synergy). | Posted | Count of Participants | Participants | 1 year postoperative |
|
|
|
| Secondary | 2 Years Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Data from hips with all with RSA information at 2 years (21 MIS and 16 Synergy). | Posted | Count of Participants | Participants | 2 years postoperative |
|
|
|
| Secondary | 3 Years Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Data from all enrolled hips who received a study device (15 MIS and 13 Synergy). | Posted | Count of Participants | Participants | 3 years postoperative |
|
|
|
| Secondary | 5 Years Postoperative Radiographic Assessments | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Data from all enrolled hips who received a study device (17 MIS and 12 Synergy). | Posted | Count of Participants | Participants | 5 years postoperative |
|
|
|
| Primary | Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement) | Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System. | Statistical comparisons were done using data from hips with all with RSA information at 2 years (20 MIS and 18 Synergy). | Posted | Mean | Full Range | degrees | Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported |
|
|
|
| 0 |
| 21 |
| 2 |
| 21 |
| 15 |
| 21 |
| EG001 | Synergy Hip System | Standard total hip arthroplasty (THA) using total hip system. | 1 | 20 | 4 | 20 | 15 | 20 |
| Subluxed patella/medial patellar retinacular repair | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Osteoarthritis total knee replacement | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Adverse soft tissue reaction secondary to dual taper from modular neck | Product Issues | Proprietary system | Systematic Assessment |
|
| Stroke | Blood and lymphatic system disorders | Proprietary system | Systematic Assessment |
|
| Hip dislocation | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Hip instability | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Unresectable pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Proprietary system | Systematic Assessment |
|
| Leg Pain | Injury, poisoning and procedural complications | Proprietary system | Systematic Assessment |
|
| Torn meniscus | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Degenerative changes with narrowing of the joint line and osteophytic changes | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Proprietary system | Systematic Assessment |
|
| Radiographic review finding of 5mm stem subsidence from fibrous ingrowth hip stem | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Stem revision right hip replacement | Injury, poisoning and procedural complications | Proprietary system | Systematic Assessment |
|
| Trochanteric bursitis | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Bleeding duodenal ulcer | Gastrointestinal disorders | Proprietary system | Systematic Assessment |
|
| Subphrenic abscess | Gastrointestinal disorders | Proprietary system | Systematic Assessment |
|
| Stitch abscess | Infections and infestations | Proprietary system | Systematic Assessment |
|
| Femoral hernia | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Medial compartmental arthritis | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Proprietary system | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Reaction to metal debris/ metal allergy | Product Issues | Proprietary system | Systematic Assessment |
|
| Pain in study hip | Injury, poisoning and procedural complications | Proprietary system | Systematic Assessment |
|
| Partial peroneal nerve palsy | Nervous system disorders | Proprietary system | Systematic Assessment |
|
| Buttock pain/soreness/discomfort | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Stress shielding as indicated on radiographic findings CRF | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Lysis over greater trochanter of total hip replacement | Blood and lymphatic system disorders | Proprietary system | Systematic Assessment |
|
| Pain in anterior aspect of knee possible flare-up of scar tissue | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Proprietary system | Systematic Assessment |
|
| Hip dislocation | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Fractured ankle | Injury, poisoning and procedural complications | Proprietary system | Systematic Assessment |
|
| L2-3,L4-5 Spinal stenosis;L5-S1 right-sided lateral recess stenosis, iatrogenic dural tear L4-5 | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Greater trochanteric pain | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Nonoperative tibial plateau fracture | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
|
Not provided
| D012216 |
| Rheumatic Diseases |
| Fair (70-79) |
|
| Poor (60-69) |
|
| Very Poor (<60) |
|
| Fair (70-79) |
|
| Poor (60-69) |
|
| Very Poor (<60) |
|
| Fair (70-79) |
|
| Poor (60-69) |
|
| Very Poor (<60) |
|
| Fair (70-79) |
|
| Poor (60-69) |
|
| Very Poor (<60) |
|
| Fair (70-79) |
|
| Poor (60-69) |
|
| Very Poor (<60) |
|
| Fair (70-79) |
|
| Poor (60-69) |
|
| Very Poor (<60) |
|
| Daily Living (0-100) |
|
| Sports/ Recreational Activities (0-100) |
|
| Quality of Life (0-100) |
|
| Daily Living (0-100) |
|
| Sports/ Recreational Activities (0-100) |
|
| Quality of Life (0-100) |
|
| Daily Living (0-100) |
|
| Sports/ Recreational Activities (0-100) |
|
| Quality of Life (0-100) |
|
| Daily Living (0-100) |
|
| Sports/ Recreational Activities (0-100) |
|
| Quality of Life (0-100) |
|
| Daily Living (0-100) |
|
| Sports/ Recreational Activities (0-100) |
|
| Quality of Life (0-100) |
|
| Daily Living (0-100) |
|
| Sports/ Recreational Activities (0-100) |
|
| Quality of Life (0-100) |
|
| Acetabular Cup Subsidence |
|
| Stem Subsidence |
|
| Evidence of Acetabular Component Failure |
|
| Evidence of Femoral Component Failure |
|
| Acetabular Cup Subsidence |
|
| Stem Subsidence |
|
| Evidence of Acetabular Component Failure |
|
| Evidence of Femoral Component Failure |
|
| Acetabular Cup Subsidence |
|
| Stem Subsidence |
|
| Evidence of Acetabular Component Failure |
|
| Evidence of Femoral Component Failure |
|
| Acetabular Cup Subsidence |
|
| Stem Subsidence |
|
| Evidence of Acetabular Component Failure |
|
| Evidence of Femoral Component Failure |
|
| Acetabular Cup Subsidence |
|
| Stem Subsidence |
|
| Evidence of Acetabular Component Failure |
|
| Evidence of Femoral Component Failure |
|
| Acetabular Cup Subsidence |
|
| Stem Subsidence |
|
| Evidence of Acetabular Component Failure |
|
| Evidence of Femoral Component Failure |
|
| Mean rotation: Varus-valgus tilt |
|