Overview

This trial is active, not recruiting.

Condition osteoarthritis of the knee
Treatment kinespring system
Sponsor Moximed
Start date December 2012
End date April 2017
Trial size 110 participants
Trial identifier NCT01738165, KINE-1203

Summary

The purpose of this pilot study is to collect data on the safety and effectiveness of the KineSpring System in patients with primarily unicompartmental medial knee osteoarthritis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Surgical intervention In this single arm study, the KineSpring System will be surgically implanted in up to 110 study patients.
kinespring system Arthroplasty, Unicompartmental Knee Arthroplasty (UKA)
The KineSpring System is designed to treat pain and loss of function secondary to medial knee OA by absorbing joint overload.

Primary Outcomes

Measure
The primary endpoint of this pilot study is the rate of individual patient success at 24 months.
time frame: 24 months post procedure

Secondary Outcomes

Measure
Secondary effectiveness endpoint - EuroQol (EQ-5D)
time frame: Assessed preprocedure and at 6 weeks and 3, 6, 12, 24, 36, 48, 60 mths post procedure
Secondary Safety Endpoints
time frame: At time of procedure and through 60 month follow-up
Secondary effectiveness endpoint - High-Activity Arthroplasty Score (HAAS)
time frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure
Secondary effectiveness endpoint - VAS
time frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure
Secondary effectiveness endpoint - KOOS
time frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure
Secondary effectiveness endpoint - Participant Global Assessment
time frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure
Secondary effectiveness endpoint
time frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure
Secondary Imaging Endpoints - Radiographic
time frame: Assessed preprocedure, pre-hospital discharge, and 3, 12, and 60 mths post procedure
Secondary Imaging Endpoints - MRI
time frame: Assessed preprocedure and at 24 months post procedure

Eligibility Criteria

Male or female participants from 25 years up to 80 years old.

Inclusion Criteria (Significant criteria only. Others also apply): - Patients with symptoms of knee pain and loss of knee function. - Patients with a diagnosis of osteoarthritis or post-traumatic osteoarthritis in the medial compartment of the knee. - Radiographic confirmation of mild to moderate medial compartment knee OA Exclusion Criteria (Significant criteria only. Others also apply): - Patients that that require knee joint replacement. - Symptomatic OA in lateral compartment or patellofemoral compartment. - Known sensitivity to metals including cobalt, chromium, iron, or nickel - Rheumatoid arthritis, other forms of inflammatory joint disease

Additional Information

Official title Prospective, Multi-Center, Pilot Study to Evaluate Symptom Relief in Patients With Medial Knee Osteoarthritis (OA) Treated With the KineSpring® Knee Implant for Load Reduction
Principal investigator Jack Farr, MD
Description The KineSpring System is indicated to treat symptoms of pain and loss of knee function in patients with a diagnosis of osteoarthritis or post-traumatic osteoarthritis in the medial compartment of the knee. The KineSpring System is indicated for patients with osteoarthritis of severity that does not require knee joint replacement.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Moximed.