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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient who received the Exception stem | Patient who received the Exception stem between January 2008 and September 2012 and consented to the original data collection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total hip arthoplasty (THA) | Device | 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. |
| 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 |
| 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 |
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At the time of surgery, the inclusion criteria were based on the indications presented in the IFUs:
At the time of surgery, the exclusion criteria were based on the contraindications presented in the IFUs:
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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.
For this retrospective and prospective study, only the patients who had consented to the original data collection after their surgery will be contacted.
These the patients should be capable of understanding the surgeon's explanations and following his instructions, should be able and willing to participate in the last follow-up visit, and should give consent to take part in the study. The patients should meet all the inclusion criteria and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Achakri | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Princesse Paola | Aye | 6900 | Belgium | |||
| CH Alpes Léman |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D006618 | Hip Dislocation, Congenital |
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
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] |
| Contamine-sur-Arve |
| 74130 |
| France |
| CH Annecy Genevois | Épagny | 74370 | France |
| Hopital Renee Sabran | Hyères | 83406 | France |
| Clinique Basseres Kacem-Boudhar | Nîmes | 30900 | France |
| Hôpitaux Du Léman | Thonon-les-Bains | 74203 | France |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000082602 | Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |