NCT04349046Active, not recruiting
Exception Cementless Hip Stem
Exception Cementless Femoral Stem in Total Hip Arthroplasty. A Multicenter, Retrospective and Prospective, Non-controlled Post Market Clinical Follow-up Study (Implants and Instrumentation)
Source: ClinicalTrials.gov · Last updated 18 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 332 (estimated)
- First submitted
- 14 Apr 2020
- Start date
- 1 Jan 2021
- Primary completion date
- 1 May 2024
- Lead sponsor
- Zimmer Biomet
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04349046
What you commit to
- Study type: Observational
- Planned participants: 332
- From 1 Jan 2021 to the primary completion date, 1 May 2024
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to 100 years · Sex: All
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Princesse Paola Coordinator of this site? Confirm its status | Aye | Belgium | Unknown status |
| CH Alpes-Léman Coordinator of this site? Confirm its status | Contamine-sur-Arve | France | Unknown status |
| CH Annecy Genevois Coordinator of this site? Confirm its status | Épagny | France | Unknown status |
| Hopital Renee Sabran Coordinator of this site? Confirm its status | Hyères | France | Unknown status |
| Clinique Basseres Kacem-Boudhar Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Hôpitaux du Léman Coordinator of this site? Confirm its status | Thonon-les-Bains | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.