Exception Cementless Hip Stem (Exception)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Inflammatory Arthritis; Osteoarthritis, Hip; Femoral Neck Fractures; Congenital Hip Dysplasia; Avascular Necrosis of Hip
• Intervention / Treatment: Device: Total hip arthoplasty (THA)

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.

• Study Type: Observational
• Enrollment (Estimated): 332

Contacts and Locations

• Study Contact: Name: Ahmed Bouzekrini; Phone Number: +33 0652095034; Email: ahmed.bouzekrini@zimmerbiomet.com

Study Locations

• Belgium
  • Aye, Belgium, 6900
    • Not yet recruiting
    • Hôpital Princesse Paola
• France
  • Contamine-sur-Arve, France, 74130
    • Not yet recruiting
    • CH Alpes Léman
  • Hyères, France, 83406
    • Not yet recruiting
    • Hôpital Renée Sabran
  • Nîmes, France, 30900
    • Recruiting
    • Clinique Basseres Kacem-Boudhar
  • Thonon-les-Bains, France, 74203
    • Not yet recruiting
    • Hôpitaux du Léman
  • Épagny, France, 74370
    • Recruiting
    • Ch Annecy Genevois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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.

For this retrospective and prospective study, only the patients who had consented to the original data collection after their surgery will be contacted.

These the patients should be capable of understanding the surgeon's explanations and following his instructions, should be able and willing to participate in the last follow-up visit, and should give consent to take part in the study. The patients should meet all the inclusion criteria and none of the exclusion criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc		10 years post-surgery
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
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
Safety based on eventual complications occurred including dislocations and revisions/removals		10 years post-surgery]

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hassan Achakri, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Performance; Total hip arthroplasty; Hip prosthesis; Medical device; Clinical benefits
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Femoral Fractures; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Osteoarthritis; Hip Fractures; Arthritis; Necrosis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Osteoarthritis, Hip; Femoral Neck Fractures
• Other Study ID Numbers: CME2018-45H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No