Exception Cementless Hip Stem

NCT04349046 | Active Not Recruiting

• 1 other identifier: CME2018-45H
• Study Type: observational
• Target: 332
• Locations: 2 countries
• Sites: 6

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.

Conditions

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

Keywords

Total hip arthroplasty; Medical device; Performance; Safety; Hip prosthesis; Clinical benefits

Outcome Measures

Primary Outcomes (1)

• Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method

  10 years post-surgery

Secondary Outcomes (4)

• Pain and functional performance based on the Harris Hip Score

  10 years post-surgery

• Subject quality-of-life determined by the EQ-5D (EuroQoI) score

  10 years post-surgery

• X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc

  10 years post-surgery

• Safety based on eventual complications occurred including dislocations and revisions/removals

  10 years post-surgery]

Study Arms (1)

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)

Interventions

Total hip arthoplasty (THA) 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.

Patient who received the Exception stem

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (6)

Hôpital Princesse Paola

Aye, 6900, Belgium

Location

CH Alpes Léman

Contamine-sur-Arve, 74130, France

Location

CH Annecy Genevois

Épagny, 74370, France

Location

Hopital Renee Sabran

Hyères, 83406, France

Location

Clinique Basseres Kacem-Boudhar

Nîmes, 30900, France

Location

Hôpitaux Du Léman

Thonon-les-Bains, 74203, France

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Arthritis, Rheumatoid; Arthritis; Hip Dislocation, Congenital; Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: January 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (5)