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

A Prospective Randomized Study on Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Arthroplasty Implant Designs

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00755144

Enrollment

200

Registered

2008-09-18

Start date

2007-04-30

Completion date

2011-01-31

Last updated

2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

DEVICELCS Knee

Cementless total knee arthroplasty with LCS Knee

DEVICEROCC Knee

Cementless total knee arthroplasty with ROCC Knee

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
American Knee Society Score	Preoperative, 8weeks, 1 year

Secondary

Measure	Time frame
WOMAC	preoperative, 8 weeks, 1 year
VAS Pain	Preoperative, 4weeks, 8weeks, 3months, 1 year

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026