Accolade® TMZF® Hip Stem Outcomes Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral stem.

Detailed Description
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A prospective, post-market, multi-centered clinical evaluation of the Accolade® TMZF® hip stem device. All patients enrolled will receive the study device. All study patients will undergo a preoperative central Dual energy X-ray absorptiometry (DXA) scan to determine bone mineral density (BMD) values.

Official Title
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Accolade® TMZF® Study A Prospective, Post-market, Non-randomized, Multi-center Evaluation of the Accolade® TMZF® Hip Stem

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Device: Accolade® TMZF® Hip Stem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is a candidate for a primary total hip replacement. Patient has primary diagnosis of osteoarthritis (OA). Male and non-pregnant female patients ages 18 to 90. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form. Patient willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. Patient capable of undergoing a pre-op central DXA (dual-energy x-ray absorptiometry) scan for a bone mineral density (BMD) reading. Exclusion Criteria: Patient has an active infection within the affected hip joint. Patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint. Patient who is morbidly obese, Body Mass Index (BMI) > 40. Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device. Patient has the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia. Patient is immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery. Patient is a prisoner.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Accolade® TMZF® Hip Stem<br>Accolade® TMZF® Hip Stem Study Device | Device: Accolade® TMZF® Hip Stem<br>* Accolade® TMZF® Hip Stem<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) of Hip Stems With Aseptic Loosening | Aseptic loosening is defined as a continuous radiolucency that surrounds the entire femoral stem porous coating-bone interface and that measures greater than 2 mm in thickness, and 5 mm or more of stem subsidence. Continuous radiolucency must be present in Zones 1, 2, 6 and 7 of the AP radiographic view and/or present in Zones 8, 9, 13 and 14 of the M/L radiographic view. | 5 years | 
| Revision/Removal Rates | The percentage (%) of hips with revision or removal of any total hip replacement component (acetabular cup, femoral stem or femoral head) is reported at the 2 and 5 year postoperative intervals. | 2 and 5 years | 
| Change in Harris Hip Score (HHS) | The change in HHS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores. 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 of less than or equal to 79 is considered fair-poor. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor. | Preoperative, 2 and 5 years | 
| Change in SF-12 Score | The change in SF-12 is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | Preoperative, 2 and 5 years | 
| Change in Lower Extremity Activity Scale (LEAS) Score | The change in LEAS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. The mean preoperative, 2 and 5 year scores are reported to assess improvement. | Preoperative, 2 and 5 years | 
| PEQ (Patient Expectation Questionnaire) Overall Satisfaction | The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement. EXPECTATIONS KEY: Participate in recreational activities (dancing,traveling,gardening) Exercise or participate in sports Independently perform household chores/daily routine Easily change position,sit to stand/stand to sit Remove need for cane crutch or walker Use stairs normally step by step Ability to sleep through night Maintain social activites,caring for someone,playing with children Use public transportation or drive Maintain psychological well-being Maintain sexual activity Maintain employment | 6 months, 1 year and 2 years | 
| PEQ (Patient Evaluation Questionnaire) Percent Achievement | The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement. EXPECTATIONS KEY: Participate in recreational activities (dancing,traveling,gardening) Exercise or participate in sports Independently perform household chores/daily routine Easily change position,sit to stand/stand to sit Remove need for cane crutch or walker Use stairs normally step by step Ability to sleep through night Maintain social activites,caring for someone,playing with children Use public transportation or drive Maintain psychological well-being Maintain sexual activity Maintain employment | 6 months, 1 year, 2 years | 
| Acetabular Insert Wear | The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years. | 5 years | 
| Wrist DXA Scan Analysis | DXA is a bone densitometry scan that measures bone mineral density and assigns a T-score. This score shows the amount of bone a patient has compared with a young adult of the same gender with peak bone mass. A score above -1 is considered normal. A score between -1 and -2.5 is classified as osteopenia (low bone mass). A score below -2.5 is defined as osteoporosis. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis