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Completed

NCT Number: NCT00755144

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

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.

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Key information

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Musgrave Park Hospital

Belfast, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LCS Knee

Device

Cementless total knee arthroplasty with LCS Knee

ROCC Knee

Device

Cementless total knee arthroplasty with ROCC Knee

Primary outcomes

  1. American Knee Society Score

    Time frame: Preoperative, 8weeks, 1 year

Secondary outcomes

  1. WOMAC

    Time frame: preoperative, 8 weeks, 1 year

  2. VAS Pain

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

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Collaborators

  • Biomet U.K. Ltd.

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 18, 2008
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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