NCT03410940

PMCF Study of the CLS Brevius Stem With Kinectiv Technology

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 223 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	CLS Brevius stem with Kinectiv technology

Timeline

• Start date: 2011-01-07
• Primary completion: 2019-04-08
• Completion: 2020-12-14
• First posted: 2018-01-25
• Last updated: 2020-12-17

Locations

4 sites across 3 countries: Italy, Poland, Spain

Regulatory

• FDA-regulated device study