Osteoarthritis of the KneeNCT00865865
Computer Aided Gap Balancing Improves Sagittal Stability and Outcomes for Cruciate-Retaining Total Knee Arthroplasty
A study testing Computer aided total knee arthroplasty and Conventional total knee arthroplasty in people with Osteoarthritis of the Knee, run by Singapore General Hospital.
Trial summary
Computer Aided Surgery in total knee arthroplasty improves knee stability and functional outcomes more than conventional total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Computer aided total knee arthroplasty and Conventional total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- primary osteoarthritis of the knee
Who cannot join
- rheumatoid arthritis, previous knee surgery, infection and those who could not be treated with unconstrained cruciate retaining TKA and a short stem tibial implant
About this study
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
Computer Aided Surgery in total knee arthroplasty improves knee stability and functional outcomes more than conventional total knee arthroplasty.
Read the 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.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Computer aided total knee arthroplasty, Conventional total knee arthroplasty
- Keywords
- Knee, Computer, Gap, Soft tissue, Balancing, Replacement, Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Capillary Malformation-Arteriovenous Malformation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer aided total knee arthroplastyProcedure or surgery
Also called Computer aided surgery
Use of computer aided surgery to balance soft tissue tension in total knee arthroplasty
Conventional total knee arthroplastyProcedure or surgery
Conventional method of total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Conventional total knee arthroplasty Receives: Procedure: Conventional total knee arthroplasty |
| 2 | Active comparator | Computer aided total knee arthroplasty Receives: Procedure: Computer aided total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sagittal stability of knee
Measured: 2 YEARS
Secondary outcomes (1)
Functional status of postoperative patients
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startMay 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- SENG-JIN YEO, FRCS, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865865
- Sponsor's protocol ID
- #48/2006
- Status last verified
- Mar 2009
- First submitted
- 17 Mar 2009
- Last updated
- 19 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00865865
- Acronym / sponsor ID
- #48/2006
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Knee, Computer, Gap, Soft tissue, Balancing, Replacement, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Computer Aided Surgery in total knee arthroplasty improves knee stability and functional outcomes more than conventional total knee arthroplasty.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Conventional total knee arthroplastyConventional total knee arthroplasty |
| 2 | Active comparator | Procedure: Computer aided total knee arthroplastyComputer aided total knee arthroplasty |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary osteoarthritis of the knee
Key exclusion criteria (1 listed)
- rheumatoid arthritis, previous knee surgery, infection and those who could not be treated with unconstrained cruciate retaining TKA and a short stem tibial implant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer aided total knee arthroplastyAlso: Computer aided surgeryUse of computer aided surgery to balance soft tissue tension in total knee arthroplasty | Procedure or surgery | 2 |
| Conventional total knee arthroplastyConventional method of total knee arthroplasty | Procedure or surgery | 1 |
Primary outcome
Sagittal stability of knee
Time frame: 2 YEARS
1 secondary outcome
Functional status of postoperative patients
Time frame: 2 YEARS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SENG-JIN YEO, FRCS principal investigator
Singapore General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Computer aided total knee arthroplasty and Conventional total knee arthroplasty in people with Osteoarthritis of the Knee, run by Singapore General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sagittal stability of knee (time frame: 2 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2009.