PMCF Study of the CLS Brevius Stem With Kinectiv Technology
NCT ID: NCT03410940
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
223 participants
OBSERVATIONAL
2011-01-07
2020-12-14
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
CLS Brevius stem with Kinectiv technology
Interventions
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CLS Brevius stem with Kinectiv technology
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Paola Vivoda
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
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Istituto Ortopedico Rizzoli
Bologna, , Italy
Istituto Ortopedico Galeazzi
Milan, , Italy
SPSK im. Prof. A. Grucy
Otwock, , Poland
HUA Santiago
Vitoria-Gasteiz, , Spain
Countries
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Other Identifiers
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CME2011-02H
Identifier Type: -
Identifier Source: org_study_id