Clinical trial NCT03410940: PMCF Study of the CLS Brevius Stem With Kinectiv Technology
Official title: Post-Market Clinical Follow-Up (PMCF) Study of the CLS Brevius Stem With Kinectiv Technology
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Femoral Neck Fractures
Prosthesis Failure
Keywords: Total Hip Arthroplasty
CLS Brevius
Kinectiv
Medical Device
Performance
Safety
Hip Prosthesis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-01-25
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Implant survivorship is assessed counting the number of implant revisions
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Milan
country: Italy
facility: Istituto Ortopedico Galeazzi
city: Otwock
country: Poland
facility: SPSK im. Prof. A. Grucy
city: Vitoria-Gasteiz
country: Spain
facility: HUA Santiago
Study officials:
affiliation: Zimmer Biomet
name: Paola Vivoda
role: STUDY_DIRECTOR
References: