OsteoarthritisPhase 4NCT00346788
The Subvastus Approach in Total Knee Arthroplasty
A Phase 4 study testing Surgical approach for total knee arthroplasty in people with Osteoarthritis, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The purpose of this study is to determine if the observed benefits of minimally invasive total knee arthroplasty, namely decreased hospital stay and increased range of motion, can be achieved with standard knee arthroplasty using the subvastus approach. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Surgical approach for total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2005to Mar 2011
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- You are willing to take part in the study, including signing this form after carefully reading it.
- You are available for follow-up for a minimum of 24 months (2 years).
- You have no medical conditions that prevent you from having surgery.
- This is the primary (first) knee replacement for this knee
- You are fluent in English and are able to understand your responsibilities in this study.
Who cannot join
- Active, local or systemic infection
- Fibromyalgia or other chronic pain syndrome
- Inability to follow the study requirements
- Had this knee replaced before
- Had a previous surgery on this knee that would interfere with the MIS approach (examples are femoral-femoral bypass, femoral-popliteal bypass, and quadricepsplasty)
- Body Mass Index (BMI) > 35, as you would not be eligible for the MIS approach.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if the observed benefits of minimally invasive total knee arthroplasty, namely decreased hospital stay and increased range of motion, can be achieved with standard knee arthroplasty using the subvastus approach.
- Conditions
- Osteoarthritis
- Being tested
- Surgical approach for total knee arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical approach for total knee arthroplastyProcedure or surgery
total knee arthroplasty surgery using minimally invasive surgery or standard technique.
| Study group | Role | What they receive |
|---|---|---|
| MIS | Experimental | minimally invasive incision Receives: Procedure: Surgical approach for total knee arthroplasty |
| Standard | Active comparator | Standard incision length Receives: Procedure: Surgical approach for total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: Post Operative
Range of motion at discharge and six weeks post-operatively
Measured: Discharge and six weeks post operative
Secondary outcomes (7)
Wound complications
Measured: post operative until wound healed
Post-operative narcotic use
Measured: 24 months post operative
Post-operative blood loss
Measured: Post operative
The ability to straight-leg raise at two and twenty-four hours post-operatively
Measured: 2 and 24 hours post operative
Knee Society Clinical Rating Scale
Measured: pre-op, 6 months, 12 months, and 24 months post operative
SF-12
Measured: pre-op, 6 months, 12 months, and 24 months post operative
WOMAC.
Measured: pre-op, 6 months, 12 months, and 24 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2006 (estimated)
- Study startJan 2005
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ross K Leighton, MD, FRCS(C), Principal investigator, Capital Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346788
- Sponsor's protocol ID
- CDHA-RL-001
- Status last verified
- May 2008
- First submitted
- 29 Jun 2006
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Subvastus Approach in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00346788
- Acronym / sponsor ID
- CDHA-RL-001
- Conditions
- Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 30 Jun 2006 (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.
The purpose of this study is to determine if the observed benefits of minimally invasive total knee arthroplasty, namely decreased hospital stay and increased range of motion, can be achieved with standard knee arthroplasty using the subvastus approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIS | Experimental | Procedure: Surgical approach for total knee arthroplastyminimally invasive incision |
| Standard | Active comparator | Procedure: Surgical approach for total knee arthroplastyStandard incision length |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- You are willing to take part in the study, including signing this form after carefully reading it.
- You are available for follow-up for a minimum of 24 months (2 years).
- You have no medical conditions that prevent you from having surgery.
- This is the primary (first) knee replacement for this knee
- You are fluent in English and are able to understand your responsibilities in this study.
Key exclusion criteria (6 listed)
- Active, local or systemic infection
- Fibromyalgia or other chronic pain syndrome
- Inability to follow the study requirements
- Had this knee replaced before
- Had a previous surgery on this knee that would interfere with the MIS approach (examples are femoral-femoral bypass, femoral-popliteal bypass, and quadricepsplasty)
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 |
|---|---|---|
| Surgical approach for total knee arthroplastytotal knee arthroplasty surgery using minimally invasive surgery or standard technique. | Procedure or surgery | MIS, Standard |
Primary outcome
Length of hospital stay
Time frame: Post Operative
Range of motion at discharge and six weeks post-operatively
Time frame: Discharge and six weeks post operative
7 secondary outcomes
Wound complications
Time frame: post operative until wound healed
Post-operative narcotic use
Time frame: 24 months post operative
Post-operative blood loss
Time frame: Post operative
The ability to straight-leg raise at two and twenty-four hours post-operatively
Time frame: 2 and 24 hours post operative
Knee Society Clinical Rating Scale
Time frame: pre-op, 6 months, 12 months, and 24 months post operative
SF-12
Time frame: pre-op, 6 months, 12 months, and 24 months post operative
WOMAC.
Time frame: pre-op, 6 months, 12 months, and 24 months post operative
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 18 Feb 2025.
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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.
Ross K Leighton, MD, FRCS(C) principal investigator
Capital Health, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgical approach for total knee arthroplasty in people with Osteoarthritis, run by Nova Scotia Health Authority at 1 site in Canada.
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 5 inclusion and 6 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 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Length of hospital stay (time frame: Post Operative). The study lists 2 primary outcomes in all. 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 18 Feb 2025.