PMCF Study of the CLS Brevius Stem With Kinectiv Technology

Rheumatoid Arthritis Clinical Trial

Official title:

Post-Market Clinical Follow-Up (PMCF) Study of the CLS Brevius Stem With Kinectiv Technology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03410940
• Other study ID #: CME2011-02H
• Status: Terminated
• Start date: January 7, 2011
• Est. completion date: December 14, 2020

Study information

• Verified date: December 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The CLS Brevius Stem with Kinectiv Technology (also referred to as CLS Brevius Kinectiv Stem) is a straight, cementless stem which is based on the successful anchoring philosophy of the CLS Spotorno Stem. In order to be more bone-conserving, the stem was distally shortened by 20% compared to the CLS Spotorno Stem. To restore individual patients' anatomies more accurately, the CLS Brevius Stems are fused with the existing Zimmer Kinectiv Modular Neck Technology.

The objectives of this study are to confirm the safety and performance of the CLS Brevius Kinectiv Stem when used in primary total hip arthroplasty. Safety will be evaluated by monitoring the frequency and incidence of adverse events. Performance will be determined by analyzing the implant survival, overall pain and functional performances, subject quality-of-life and radiographic parameters of study subjects who received the CLS Brevius Kinectiv Stem.

In addition, metal ion levels (titanium and aluminium) will be analyzed pre-operatively and at 6 months, 1, 2 and 5 years in a subset of 70 to 80 patients (30 to 35%).

The primary endpoint is defined as the implant survival at 10 years. Indication: Patients suffering from severe hip pain and disability requiring total hip arthroplasty and who meet the inclusion/exclusion criteria.

Study design: multi-center, prospective, non-controlled. Length of Study: 12 years (20 months enrollment plus 10 years follow-up): follow-up visits at 6 months, 1,2,3,5,7 and 10 years post-operatively.

A maximum total of 230 patients will be enrolled in the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 223
• Est. completion date: December 14, 2020
• Est. primary completion date: April 8, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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'.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Device:
• CLS Brevius stem with Kinectiv technology

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna
Italy	Istituto Ortopedico Galeazzi	Milan
Poland	SPSK im. Prof. A. Grucy	Otwock
Spain	HUA Santiago	Vitoria-Gasteiz

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survivorship is assessed counting the number of implant revisions		10 years