PMCF Study of the CLS Brevius Stem With Kinectiv Technology

Sponsor

Zimmer Biomet (Industry)

Overall Status

Terminated

CT.gov ID

NCT03410940

Collaborator

(none)

223

Enrollment

Locations

119.2

Actual Duration (Months)

55.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Femoral Neck Fractures Prosthesis Failure	Device: CLS Brevius stem with Kinectiv technology

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

223 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 7, 2011

Actual Primary Completion Date :

Apr 8, 2019

Actual Study Completion Date :

Dec 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Implant survivorship is assessed counting the number of implant revisions [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Istituto Ortopedico Rizzoli	Bologna	Italy	40136
2	Istituto Ortopedico Galeazzi	Milan	Italy	20161
3	SPSK im. Prof. A. Grucy	Otwock	Poland	05-400
4	HUA Santiago	Vitoria-Gasteiz	Spain	01004