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

Zimmer Biomet200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Osteoarthritis

Interventions

LCS KneeDEVICE

Cementless total knee arthroplasty with LCS Knee

ROCC KneeDEVICE

Cementless total knee arthroplasty with ROCC Knee

Eligibility

Sex: ALLMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Musgrave Park Hospital

Belfast, United Kingdom

Outcomes

Primary Outcomes

American Knee Society Score

Time frame: Preoperative, 8weeks, 1 year

Secondary Outcomes

WOMAC

Time frame: preoperative, 8 weeks, 1 year

VAS Pain

Time frame: Preoperative, 4weeks, 8weeks, 3months, 1 year

Data from ClinicalTrials.gov

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