A Randomized Control Trial to Assess Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Implant Designs

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Device: ROCC Knee; Device: LCS Knee

• Registration Number: NCT00755144
• Lead Sponsor: Zimmer Biomet

Brief Summary

This is a prospective Randomised Control Trial to compare the Early Clinical and Functional Outcome of the ROCC and LCS total knee arthroplasty implant designs.

Detailed Description

This study compares two similar designs of cementless rotating bearing total condylar knee replacements. The study will be conducted at a single clinical unit with a senior orthopaedic surgeon implanting all devices.Their performances will be assessed by clinical scores and comprehensive function outcome documentation undertaken by qualified physiotherapists. The persons undertaking the assessments will be blinded to which implants the patients have.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-09-17
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients suitable for cementless knee replacement
• Patients skeletally mature and under 80 years of age at pre-operative clinic
• Patients presenting with osteoarthritis of the knee
• Patients must be ambulatory at time of pre-operative clinic
• Patients must be able to understand instructions and be will to return for follow-up

Exclusion Criteria

• Previous knee surgery (except arthroscopic/open menisectomy)
• Patients with inflammatory arthritis
• Patients with significant medical co-morbidity - ASA IV
• Disorders causing abnormal gait or significant pain
• Patients unable to consent
• Severe visual impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ROCC Knee	ROCC
2	LCS Knee	LCS

Primary Outcome Measures

Name	Time	Method
American Knee Society Score	Preoperative, 8weeks, 1 year

Secondary Outcome Measures

Name	Time	Method
WOMAC	preoperative, 8 weeks, 1 year
VAS Pain	Preoperative, 4weeks, 8weeks, 3months, 1 year

Trial Locations

Locations (1)

Musgrave Park Hospital; 🇬🇧 Belfast, United Kingdom