Exception Cementless Hip Stem

NCT04349046 · tracked via the Priya Life Science Belgium tracker

Sponsor

Zimmer Biomet

Phase

Observational

Started

2021-01-01

Last updated

2025-06-18

Condition(s) studied

Osteoarthritis, HipRheumatoid ArthritisInflammatory ArthritisCongenital Hip DysplasiaAvascular Necrosis of HipFemoral Neck Fractures

Investigational drug(s) / intervention(s)

Total hip arthoplasty (THA)

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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

Primary outcome measure(s)

Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method — 10 years post-surgery

Trial sites (6)

Facility	City	Region
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04349046 on ClinicalTrials.gov ↗ ← All trials in Belgium