Exception Cementless Hip Stem

Study Overview
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Brief Summary
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This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. The objectives of this study are to confirm the long-term safety, performance and clinical benefits the Exception Cementless femoral stem (standard and varized) when used in primary total hip arthroplasty.

Detailed Description
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Six surgeons have prospectively collected clinical data for patients operated consecutively between January 2008 and September 2012. The patients have been operated based on the indications and contraindications listed in the Instructions For Use (IFUs) of the implant. This study is an extension of the surgeons' data collection as an attempt from Zimmer-Biomet to fulfill its post-market surveillance obligations by recovering clinical data retrospectively and prospectively. Study Procedure Flowchart - retrospective data collection: most patients had clinical follow-ups at pre-op, operative, immediate post-op, 3 Months, 1 year, 2, 3, 5, 7 years post-surgery during which their surgeons collected clinical data. This data will therefore only be collected by Zimmer-Biomet after the patients specifically consent to it. Study Procedure Flowchart - prospective data collection: The informed consent signed by the patient for this study also allow Zimmer Biomet to collect the data of the standard clinical follow-up that will be conducted by the investigators at least 10 years post-surgery.

Official Title
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Exception Cementless Femoral Stem in Total Hip Arthroplasty. A Multicenter, Retrospective and Prospective, Non-controlled Post Market Clinical Follow-up Study (Implants and Instrumentation)

Conditions
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Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis, Congenital Hip Dysplasia, Avascular Necrosis of Hip, Femoral Neck Fractures

Intervention / Treatment
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* Device: Total hip arthoplasty (THA)


Participation Criteria
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Eligibility Criteria
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At the time of surgery, the inclusion criteria were based on the indications presented in the IFUs: Primary or secondary osteoarthritis Inflammatory impairment of the hip, rheumatoid arthritis, etc. Fracture of the neck of the femur Avascular necrosis of the femoral head Sequelae from previous operations on the hip, osteotomies, etc. Congenital hip dysplasia. Patient is older than 18 years old Patient had consented to the original data collection after his/her surgery At the time of surgery, the exclusion criteria were based on the contraindications presented in the IFUs: Local or systemic infections. Serious muscular, neurological or vascular deficiencies in the limb concerned. Bone destruction or poor quality bone likely to affect the stability of the implant (Paget's disease, osteoporosis, etc.) Any concomitant disorder likely to affect the function of the implant. Allergy to one of the implant components. Patients weighing more than 110 kg. Patient incapable of following the recommendations of the surgeon

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient who received the Exception stem<br>Patient who received the Exception stem between January 2008 and September 2012 and consented to the original data collection. | Device: Total hip arthoplasty (THA)<br>* Total hip arthroplasty (THA) is a common operative treatment where an arthritic, degenerative or fractured hip joint is replaced with a prosthetic device if conservative options are unable to relieve pain and debilitating symptoms. THA was traditionally performed on patients over 60 years old, but now includes young and active patients, as well as very old ones thanks to the continuous improvement in implant design. Major indications of THA include osteoarthritis, rheumatoid arthritis, avascular necrosis and hip fractures. The THA surgical procedure involves replacing the head of the femur and acetabulum or socket with an artificial prosthesis. This system is composed of a femoral stem that is inserted into the femoral canal, a ball that attaches to the femoral stem, and an acetabular component or shell that replaces the acetabulum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method |  | 10 years post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and functional performance based on the Harris Hip Score | The score is given from 0 to 100 with Excellent: 90 - 100, Good: 80 - 89, Fair: 70 - 79, and Poor: < 70 | 10 years post-surgery | 
| Subject quality-of-life determined by the EQ-5D (EuroQoI) score | The lowest score (0) corresponds to the worst health the patient can imagine, and the highest rate (100) corresponds to the best health he can imagine. | 10 years post-surgery | 
| X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc |  | 10 years post-surgery | 
| Safety based on eventual complications occurred including dislocations and revisions/removals |  | 10 years post-surgery] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total hip arthroplasty, Medical device, Performance, Safety, Hip prosthesis, Clinical benefits