Exception Cementless Hip Stem

Rheumatoid Arthritis Clinical Trial

— Exception  

Official title:

Exception Cementless Femoral Stem in Total Hip Arthroplasty. A Multicenter, Retrospective and Prospective, Non-controlled Post Market Clinical Follow-up Study (Implants and Instrumentation)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04349046
• Other study ID #: CME2018-45H
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Zimmer Biomet
• Contact: Ahmed Bouzekrini
• Phone: 0652095034
• Email: ahmed.bouzekrini[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 332
• Est. completion date: December 2025
• Est. primary completion date: May 1, 2024
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Belgium	Hôpital Princesse Paola	Aye
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method		10 years post-surgery
Secondary	Pain and functional performance based on the Harris Hip Score	The score is given from 0 to 100 with Excellent: 90 - 100, Good: 80 - 89, Fair: 70 - 79, and Poor: < 70	10 years post-surgery
Secondary	Subject quality-of-life determined by the EQ-5D (EuroQoI) score	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".	10 years post-surgery
Secondary	X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc		10 years post-surgery
Secondary	Safety based on eventual complications occurred including dislocations and revisions/removals		10 years post-surgery]