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

This study has been completed.
Sponsor:
Collaborator:
Biomet U.K. Ltd.
Information provided by (Responsible Party):
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT00755144
First received: September 17, 2008
Last updated: June 16, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Osteoarthritis Device: LCS Knee Device: ROCC Knee

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study on Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Arthroplasty Implant Designs

Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • American Knee Society Score [ Time Frame: Preoperative, 8weeks, 1 year ]

Secondary Outcome Measures:
  • WOMAC [ Time Frame: preoperative, 8 weeks, 1 year ]
  • VAS Pain [ Time Frame: Preoperative, 4weeks, 8weeks, 3months, 1 year ]

Enrollment: 200
Study Start Date: April 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ROCC
Device: ROCC Knee
Cementless total knee arthroplasty with ROCC Knee
Active Comparator: 2
LCS
Device: LCS Knee
Cementless total knee arthroplasty with LCS Knee

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.
  Eligibility

Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755144

Locations
United Kingdom
Musgrave Park Hospital
Belfast, United Kingdom
Sponsors and Collaborators
Zimmer Biomet
Biomet U.K. Ltd.
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00755144     History of Changes
Other Study ID Numbers: BMET UK 05
Study First Received: September 17, 2008
Last Updated: June 16, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 28, 2017