Computer Aided Gap Balancing Improves Sagittal Stability and Outcomes for Cruciate-Retaining Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00865865
First received: March 17, 2009
Last updated: March 18, 2009
Last verified: March 2009
  Purpose

Computer Aided Surgery in total knee arthroplasty improves knee stability and functional outcomes more than conventional total knee arthroplasty.


Condition Intervention
Osteoarthritis of the Knee
Procedure: Computer aided total knee arthroplasty
Procedure: Conventional total knee arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Computer Aided Gap Balancing Improves Sagittal Stability and Outcomes for Cruciate-Retaining Total Knee Arthroplasty- 2-Year Results of a Prospective Randomised Trial

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Sagittal stability of knee [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional status of postoperative patients [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: May 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Conventional total knee arthroplasty
Procedure: Conventional total knee arthroplasty
Conventional method of total knee arthroplasty
Other Name: Conventional total knee arthroplasty
Active Comparator: 2
Computer aided total knee arthroplasty
Procedure: Computer aided total knee arthroplasty
Use of computer aided surgery to balance soft tissue tension in total knee arthroplasty
Other Name: Computer aided surgery

Detailed Description:

The success of total knee arthroplasty depends on restoration of limb alignment, precise implant positioning and optimal gap balancing. The advent of computer aided surgery (CAS) has improved limb alignment and implant positioning. The objective of this study was to evaluate the functional outcome of computer aided soft tissue gap balancing in total knee arthroplasty.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • primary osteoarthritis of the knee

Exclusion Criteria:

  • rheumatoid arthritis, previous knee surgery, infection and those who could not be treated with unconstrained cruciate retaining TKA and a short stem tibial implant
  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: NCT00865865

Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: SENG-JIN YEO, FRCS Singapore General Hospital
  More Information

No publications provided

Responsible Party: DR SENG-JIN YEO, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT00865865     History of Changes
Other Study ID Numbers: #48/2006
Study First Received: March 17, 2009
Last Updated: March 18, 2009
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Singapore General Hospital:
Knee
Computer
Gap
Soft tissue
Balancing
Replacement
Arthroplasty

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

ClinicalTrials.gov processed this record on August 28, 2014