Exception Cementless Hip Stem

NCT ID: NCT04349046

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 332 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

Total hip arthoplasty (THA)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hassan Achakri

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Hôpital Princesse Paola

Aye, , Belgium

CH Alpes Léman

Contamine-sur-Arve, , France

CH Annecy Genevois

Épagny, , France

Hopital Renee Sabran

Hyères, , France

Clinique Basseres Kacem-Boudhar

Nîmes, , France

Hôpitaux Du Léman

Thonon-les-Bains, , France

Countries

Belgium; France

Other Identifiers

CME2018-45H

Identifier Type: -

Identifier Source: org_study_id