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The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.
The two-piece modular revision stem components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. This study evaluates the System in revision cases only. The stems are intended to be used with Stryker Orthopaedics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.
In addition to demonstrating survivorship at 5 years, this study will seek to gain information on four secondary objectives: radiographic stability, Harris Hip Scores, SF-36 general well-being assessment, and safety profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restoration® Modular | Other | All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restoration® Modular Revision Hip System | Device | Restoration® Modular Revision System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stem Survivorship (%) | Failure is defined by stem revision for any cause. | 5 years |
| Femoral Stem Fracture | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Stability | Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view. | 5 years |
| Harris Hip Score | Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Barnett, MD | Orthopaedic Specialty Institute | Principal Investigator |
| Michael W Britt, MD | Orthopaedic Associates of Corpus Christi | Principal Investigator |
| Kenneth A Greene, MD | Crystal Clinic | Principal Investigator |
| Steven F Harwin, MD | Beth Israel Medical Center | Principal Investigator |
| D. Christopher Hikes, MD | Providence Health & Services | Principal Investigator |
| Kirby Hitt, MD | Scott and White Hospital | Principal Investigator |
| William Hozack, md | Rothman Institute | Principal Investigator |
| Frederick Jaffe, MD | Hospital for Joint Diseases | Principal Investigator |
| Timothy P Lovell, MD | Providence Orthopaedic Specialties | Principal Investigator |
| Mark R Matthes, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Specialty Institute | Orange | California | 92868 | United States | ||
| Iowa Orthopaedic Center |
137/139 participants/hips enrolled and 17/17 participants/hips censored=120/122 participants/hips started
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| ID | Title | Description |
|---|---|---|
| FG000 | Restoration® Modular | All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| pre-op and 5 years |
| SF-36 Health Status Survey: Role - Physical | Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state: The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health This Secondary Outcome Measure is focused on the "Role-Physical" score. | pre-op, 2 year and 5 year |
| Post-surgery Femoral Crack/Fracture and Subsidence Rate | Post-op to 5 years |
| Iowa Orthopaedic Center |
| Principal Investigator |
| Arthur Malkani, MD | Jewish Hospital Center for Advanced Medicine | Principal Investigator |
| John Schurman, MD | Kansas Joint and Spine Institute | Principal Investigator |
| John Wright, MD | New West Sports Medicine and Orthopaedic Surgery | Principal Investigator |
| Des Moines |
| Iowa |
| 50314 |
| United States |
| Kansas Joint and Spine Institute | Wichita | Kansas | 67226 | United States |
| Jewish Hospital Center for Advanced Medicine | Louisville | Kentucky | 40202 | United States |
| New West Sports Medicine and Orthopaedic Surgery | Kearney | Nebraska | 68847 | United States |
| Hospital for Joint Diseases | New York | New York | 10003 | United States |
| Beth Israel Medical Center | New York | New York | 10021 | United States |
| Crystal Clinic | Akron | Ohio | 44333 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Orthopedic Associates of Corpus Christi | Corpus Christi | Texas | 78411 | United States |
| Scott and White Hospital | Temple | Texas | 76508 | United States |
| Providence Orthopaedic Specialities | Spokane | Washington | 99204 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Includes participants who received the Restoration® Modular Hip System and were not censored from analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Restoration® Modular | All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age results are based on 118 participants as there were 2 participants missing age data. For bilateral participants, age at the time surgery for the first hip enrolled is used for the baseline measurement. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Stem Survivorship (%) | Failure is defined by stem revision for any cause. | Participants with 5 year follow-up evaluations or participant had a stem revision before they reached 5 years. | Posted | Number | 90% Confidence Interval | stem survivorship percentage at 5 years | 5 years | hips | hips |
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| Secondary | Radiographic Stability | Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view. | 41 hips had fully evaluable radiographs at the 5 year interval; 40 out of the 41 hips are stable. | Posted | Number | 95% Confidence Interval | percentage of stable hips | 5 years | hips | hips |
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| Secondary | Harris Hip Score | Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor | Posted | Mean | Standard Deviation | units on a scale | pre-op and 5 years | hips | hips |
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| Secondary | SF-36 Health Status Survey: Role - Physical | Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state: The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health This Secondary Outcome Measure is focused on the "Role-Physical" score. | SF-36 Scores were assessed for each hip. (One hip did not have a pre-operative SF-36) | Posted | Mean | Standard Deviation | units on a scale | pre-op, 2 year and 5 year | hips | hips |
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| Primary | Femoral Stem Fracture | Participants who received the Restoration Modular Hip System. | Posted | Number | femoral stem fractures | 5 years |
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| Secondary | Post-surgery Femoral Crack/Fracture and Subsidence Rate | Post-surgery femoral crack/fracture and subsidence rate were assessed by hip. | Posted | Number | percentage of hips | Post-op to 5 years | hips | hips |
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Enrollment to 5 years post-op. Censored protocol violations not included as at risk participants. Industry standard Adverse Event (AE) terms (e.g. MedDRA) were not used for AE data collection. Specific AE terms were not used for all AEs collected.
Serious AEs & AEs related to the implant/procedure collected. Elective procedures not included. i.e. non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular & bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, & mid-foot/flat-foot surgery.
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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 | Restoration® Modular | All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant. | 44 | 120 | 44 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative Site Blood and Lymphatic System Disorders | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Non-operative Site Cardiac Disorders | Cardiac disorders | Non-systematic Assessment |
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| Non-operative Site Gastrointestinal Disorders | Gastrointestinal disorders | Non-systematic Assessment |
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| Non-operative Site General Disorders | General disorders | Non-systematic Assessment |
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| Non-operative Site Hepatobiliary Disorders | Hepatobiliary disorders | Non-systematic Assessment |
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| Non-operative Site Infections and Infestations | Infections and infestations | Non-systematic Assessment |
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| Operative Site Infections or Infestations | Infections and infestations | Non-systematic Assessment |
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| Non-operative Site Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Operative Site Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Non-operative Site Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Operative Site Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Non-Operative Site Neoplasms Benigh, Malignant, and Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Non-operative Site Nervous System Disorders | Nervous system disorders | Non-systematic Assessment |
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| Non-operative Site Renal and Urinary Disorders | Renal and urinary disorders | Non-systematic Assessment |
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| Non-operative Site Respiratory, Thoracic and Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Non-operative Site Skin and Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Non-operative Site Vascular Disorders | Vascular disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative Site Injury,Poisoning and Procedural Complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Non-operative Site Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Operative Site Musculoskeleatal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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Each investigator shall have privileges for their own center's results at the completion of the study.These manuscripts and abstracts will be delayed until after the multi-center publication is submitted.All publications shall be submitted to the Sponsor for review at least 60 days prior to submission of publication.The Sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Stryker Orthopaedics | 201-831-5401 | Ellen.Axelson@stryker.com |
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