Exception Cementless Hip Stem

Active, not recruiting

• Conditions: Congenital Hip Dysplasia; Inflammatory Arthritis; Avascular Necrosis of Hip; Osteoarthritis, Hip; Rheumatoid Arthritis; Femoral Neck Fractures
• Interventions: Device: Total hip arthoplasty (THA)

• Registration Number: NCT04349046
• Lead Sponsor: Zimmer Biomet

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Study Start: 2021-01-01
• Primary Completion: 2024-05-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient who received the Exception stem	Total hip arthoplasty (THA)	Patient who received the Exception stem between January 2008 and September 2012 and consented to the original data collection.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Subject quality-of-life determined by the EQ-5D (EuroQoI) score	10 years post-surgery	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".
Safety based on eventual complications occurred including dislocations and revisions/removals	10 years post-surgery]
Pain and functional performance based on the Harris Hip Score	10 years post-surgery	The score is given from 0 to 100 with Excellent: 90 - 100, Good: 80 - 89, Fair: 70 - 79, and Poor: \< 70
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc	10 years post-surgery

Trial Locations

Locations (6)

Hôpitaux Du Léman; 🇫🇷 Thonon-les-Bains, France

Hopital Renee Sabran; 🇫🇷 Hyères, France

Clinique Basseres Kacem-Boudhar; 🇫🇷 Nîmes, France

Hôpital Princesse Paola; 🇧🇪 Aye, Belgium

CH Annecy Genevois; 🇫🇷 Épagny, France

CH Alpes Léman; 🇫🇷 Contamine-sur-Arve, France