PMCF Study of the CLS Brevius Stem With Kinectiv Technology

NCT03410940 | Terminated FDA Device

• 1 other identifier: CME2011-02H
• Study Type: observational
• Target: 223
• Locations: 3 countries
• Sites: 4

Brief Summary

This study is a multi-center, prospective, non-controlled post-market surveillance study. The primary objective of this study is to confirm the safety and performance of the CLS Brevius stem with Kinectiv technology by obtaining implant survivorship and clinical outcomes data for the commercially available stem.

Conditions

Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Femoral Neck Fractures; Prosthesis Failure

Keywords

Total Hip Arthroplasty; CLS Brevius; Kinectiv; Medical Device; Performance; Safety; Hip Prosthesis

Outcome Measures

Primary Outcomes (1)

• Implant survivorship is assessed counting the number of implant revisions

  10 years

Study Arms (1)

Subjects who received a CLS Brevius Kinectiv stem

Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and received the CLS Brevius Kinectiv stem.

Device: CLS Brevius stem with Kinectiv technology

Interventions

CLS Brevius stem with Kinectiv technology DEVICE

Subjects who received a CLS Brevius Kinectiv stem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects in need of a total hip arthroplasty, which receive the CLS Brevius Kinectiv stem and who meet all of the inclusion and none of the exclusion criteria.

You may qualify if:

• Patient is 18 years of age minimum.
• Patient is suffering from severe hip pain and disability requiring primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history.
• Patient is willing and able to cooperate in the required post-operative therapy.
• Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
• Patient has participated in the Informed Consent process and has signed the Ethics Committee approved 'Informed Consent'.

You may not qualify if:

• Patient is unwilling or unable to give consent or to comply with the follow-up program.
• Patient has a total prosthetic hip replacement device (including surface replacement arthroplasty, endoprosthesis etc.) or femoral and/or acetabular osteosynthesis of the affected hip joint(s).
• Patient is: a prisoner, mentally incompetent or unable to understand what participation in the study entails, a known alcoholic or drug abuser, anticipated to be non-compliant
• Acute, chronic local or systemic infections.
• Severe muscular, neural or vascular diseases that endanger the success of the procedure.
• Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible.
• Total or partial absence of the muscular or ligamentous apparatus.
• Any concomitant diseases that can jeopardize the functioning and the success of the implant.
• Allergy to the implanted material, above all to metal (e.g. Vanadium).
• Local bone tumors and/or cysts.
• Pregnancy.
• Skeletal immaturity.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Location

SPSK im. Prof. A. Grucy

Otwock, 05-400, Poland

Location

HUA Santiago

Vitoria-Gasteiz, 01004, Spain

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid; Femoral Neck Fractures; Prosthesis Failure

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Postoperative Complications

Study Officials

• Paola Vivoda

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 25, 2018
• Study Start: January 7, 2011
• Primary Completion: April 8, 2019
• Study Completion: December 14, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

PL (1); ES (1); IT (2)