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NCT04349046
Exception Cementless Hip Stem
Conditions: Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis, Congenital Hip Dysplasia, Avascular Necrosis of Hip, Femoral Neck Fractures
Sex: All
Ages: 18 Years – 100 Years
Enrollment: 332
Sponsor: Zimmer Biomet
Location: Hôpital Princesse Paola Aye
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT04349046). StuddyBuddy aggregates publicly available trial information.