NCT04349046

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)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 332 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: —

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Total hip arthoplasty (THA)	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-05-01
• Completion: 2025-12-01
• First posted: 2020-04-16
• Last updated: 2025-06-18

Locations

6 sites across 2 countries: Belgium, France