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PMCF Study of the CLS Brevius Stem With Kinectiv Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03410940
Recruitment Status : Terminated (The production of the device was stopped due to economic reasons. Basic post-market surveillance activities will be continued.)
First Posted : January 25, 2018
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Study Description
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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
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
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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 : January 7, 2011
Actual Primary Completion Date : April 8, 2019
Actual Study Completion Date : December 14, 2020

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Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Implant survivorship is assessed counting the number of implant revisions [ Time Frame: 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410940


Locations
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Italy
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Istituto Ortopedico Galeazzi
Milan, Italy, 20161
Poland
SPSK im. Prof. A. Grucy
Otwock, Poland, 05-400
Spain
HUA Santiago
Vitoria-Gasteiz, Spain, 01004
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Paola Vivoda Zimmer Biomet
More Information
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03410940    
Other Study ID Numbers: CME2011-02H
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Zimmer Biomet:
Total Hip Arthroplasty
CLS Brevius
Kinectiv
Medical Device
 Performance
Safety
Hip Prosthesis
Additional relevant MeSH terms:
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Necrosis
Prosthesis Failure
Femoral Neck Fractures
Pathologic Processes
Hip Fractures
Femoral Fractures
 Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Postoperative Complications