Exception Cementless Hip Stem

Zimmer Biomet

Status

Active, not recruiting

Conditions

Avascular Necrosis of Hip

Osteoarthritis, Hip

Femoral Neck Fractures

Congenital Hip Dysplasia

Inflammatory Arthritis

Rheumatoid Arthritis

Treatments

Device: Total hip arthoplasty (THA)

Study type

Observational

Funder types

Industry

Identifiers

NCT04349046

CME2018-45H

Details and patient eligibility

About

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.

Full 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.

Enrollment

332 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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