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This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.
A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner.
All potential study subjects will be required to participate in the Informed Consent process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taperloc Complete Microplasty stem | Experimental | Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem. |
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| Taperloc Complete Reduced Distal stem | Active Comparator | Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taperloc Complete Microplasty stem | Device | Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA) | Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP) | 2 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty | Assessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation. | 2 years postoperatively |
| Early Survival Assessed by Counting the Number of Implant Revisions |
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Inclusion Criteria:
Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
Correction of functional deformity.
Male or female
-≥ 18 and ≤ 70 years of age
Subjects willing to return for follow-up evaluations.
Subjects able to read and understand Dutch language.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paola Vivoda, BSc | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bravis | Roosendaal | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Taperloc Complete Microplasty Stem | Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem. Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner |
| FG001 | Taperloc Complete Reduced Distal Stem |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2017 |
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1:1 assignment of treatment
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| Taperloc Complete Reduced Distal stem | Device | Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner |
|
|
Assessed by counting the number of implant revisions |
| Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively |
| Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS) | Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points) | pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively |
| Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation | Assess radiographs for signs of stress shielding, radiolucency and stem alignment. | 6 weeks, 1 year and 2 years postoperatively |
| Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS) | The outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms. | 2 years postoperatively |
| Clinical Performance Measured by Patient Based Outcome EQ5D | Each question in the EQ5D assessment can be answered in three ways, indicating no, moderate or extreme problems. Index scores are created with a weight for each dimension, ranging from 0 (health state equivalent to death) to 1 (perfect health). The EQ5D also includes a question about health status, ranging from 0 (worst health) to 100 (best health). | 2 years postoperatively |
| Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS) | The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score. | pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively |
| Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS) | The Forgotten Joint Score (FJS) is a questionnaire, which focuses on the awareness of having a joint prosthesis. The rationale of this questionnaire is that the ultimate goal in joint arthroplasty resulting in the greatest possible patient satisfaction is the ability to forget the artificial joint. The outcome is scored on a 0 to 100 scale, with a total score of 0 indicating the highest level of awareness of having a joint prosthesis. | 6 weeks, 1 year and 2 years postoperatively |
Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem. Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner |
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| NOT COMPLETED |
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These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem.
25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).
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| ID | Title | Description |
|---|---|---|
| BG000 | Taperloc Complete Microplasty Stem | Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem. Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner |
| BG001 | Taperloc Complete Reduced Distal Stem | Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem. Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem. 25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD). | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem. 25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD). | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 | Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA) | Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP) | RSA data from 35 patients (20 Taperloc Complete Reduced Distal & 15 Taperloc Complete Microplasty) is available for the comparison of migration between the investigated stems. | Posted | Mean | Standard Deviation | mm | 2 years postoperatively |
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| Secondary | Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty | Assessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation. | Posted | Number | participants | 2 years postoperatively |
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| Secondary | Early Survival Assessed by Counting the Number of Implant Revisions | Assessed by counting the number of implant revisions | Posted | Number | implant revisions | Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively |
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| Secondary | Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS) | Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points) | Posted | Mean | Standard Deviation | scores on a scale | pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively |
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| Secondary | Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation | Assess radiographs for signs of stress shielding, radiolucency and stem alignment. | Posted | Count of Participants | Participants | 6 weeks, 1 year and 2 years postoperatively |
|
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| Secondary | Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS) | The outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms. | Posted | Mean | Standard Deviation | scores on a scale | 2 years postoperatively |
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| Secondary | Clinical Performance Measured by Patient Based Outcome EQ5D | Each question in the EQ5D assessment can be answered in three ways, indicating no, moderate or extreme problems. Index scores are created with a weight for each dimension, ranging from 0 (health state equivalent to death) to 1 (perfect health). The EQ5D also includes a question about health status, ranging from 0 (worst health) to 100 (best health). | Posted | Mean | Standard Error | score on a scale | 2 years postoperatively |
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| Secondary | Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS) | The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score. | Number of analyzed patients differs between the time points due to missing values | Posted | Mean | Standard Deviation | scores on a scale | pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively |
|
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| Secondary | Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS) | The Forgotten Joint Score (FJS) is a questionnaire, which focuses on the awareness of having a joint prosthesis. The rationale of this questionnaire is that the ultimate goal in joint arthroplasty resulting in the greatest possible patient satisfaction is the ability to forget the artificial joint. The outcome is scored on a 0 to 100 scale, with a total score of 0 indicating the highest level of awareness of having a joint prosthesis. | Number of analyzed patients differs between the time points due to missing values | Posted | Mean | Standard Deviation | score on a scale | 6 weeks, 1 year and 2 years postoperatively |
|
2 years
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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 | Taperloc Complete Microplasty Stem | Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem. Taperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner | 0 | 25 | 2 | 25 | 2 | 25 |
| EG001 | Taperloc Complete Reduced Distal Stem | Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem. Taperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner | 0 | 21 | 0 | 21 | 9 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Non-systematic Assessment |
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| hypotension | Cardiac disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stem Subsidence | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Periarticular Ossification | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Other hip related radiographic finding |
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| Pedestal Sign | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Other hip related radiographic finding |
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A limitation of the study was that 14 patients had to be excluded for RSA analysis due to insufficient bone markers or not meeting other criteria to perform an accurate RSA migration calculation. However, as Valstar et al. (2005) stated that at least 15-25 patients are needed per group, we believe that the results of this study are still valuable.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisette Smid | Zimmer Biomet | +31 62 395 6378 | lisette.smid@zimmerbiomet.com |
| Dec 24, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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