Tricompartmental GonarthrosisNCT00925626
Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial
A study testing Sub-Vastus arthrotomy and Mid - Vastus arthrotomy in people with Tricompartmental Gonarthrosis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Randomized, single-blind trial in which one group of patients will be operated with a "Mid-Vastus approach" of the knee joint and the other group will undergo knee surgery with a "Sub-Vastus approach". Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Tricompartmental Gonarthrosis
- What is being tested?
- Sub-Vastus arthrotomy and Mid - Vastus arthrotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2009to Aug 2015
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with osteoarthrosis of the knee
- patients must be in good general health condition
Who cannot join
- patients with morbid obesity (BMI >45)
- patients with history of knee surgery, infection or inflammatory disease of the knee joint or large cartilage lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial With One Year Follow-up
Randomized, single-blind trial in which one group of patients will be operated with a "Mid-Vastus approach" of the knee joint and the other group will undergo knee surgery with a "Sub-Vastus approach".
- Conditions
- Tricompartmental Gonarthrosis
- Being tested
- Sub-Vastus arthrotomy, Mid - Vastus arthrotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-Vastus arthrotomyProcedure or surgery
Sub-vastus arthrotomy
Mid - Vastus arthrotomyProcedure or surgery
Mid-vastus arthrotomy
| Study group | Role | What they receive |
|---|---|---|
| Sub - Vastus arthrotomy | Experimental | Sub-vastus arthrotomy Receives: Procedure: Sub-Vastus arthrotomy |
| Mid-Vastus arthrotomy | Active comparator | Mid-vastus arthrotomy Receives: Procedure: Mid - Vastus arthrotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS, KOOS and HSS scales
Measured: at day 1, day 2, day 3, day 4 and day 5 post-operatively
Rehabilitation time; time needed for 90° flexion of the knee joint
Measured: post-operatively
Secondary outcomes (2)
VAS, HSS, KOOS questionnaires
Measured: at 6 weeks, 3 months and 12 months after surgery.
Amount and type of analgesic drugs used.
Measured: pre-operatively and post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricompartmental GonarthrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Verdonk, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925626
- Sponsor's protocol ID
- 2009/256
- Status last verified
- Jul 2021
- First submitted
- 19 Jun 2009
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial With One Year Follow-up
- ClinicalTrials.gov ID
- NCT00925626
- Acronym / sponsor ID
- 2009/256
- Conditions
- Tricompartmental Gonarthrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jun 2009 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Jun 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.
Randomized, single-blind trial in which one group of patients will be operated with a "Mid-Vastus approach" of the knee joint and the other group will undergo knee surgery with a "Sub-Vastus approach".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub - Vastus arthrotomy | Experimental | Procedure: Sub-Vastus arthrotomySub-vastus arthrotomy |
| Mid-Vastus arthrotomy | Active comparator | Procedure: Mid - Vastus arthrotomyMid-vastus arthrotomy |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients diagnosed with osteoarthrosis of the knee
- patients must be in good general health condition
Key exclusion criteria (2 listed)
- patients with morbid obesity (BMI >45)
- patients with history of knee surgery, infection or inflammatory disease of the knee joint or large cartilage lesion
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 |
|---|---|---|
| Sub-Vastus arthrotomySub-vastus arthrotomy | Procedure or surgery | Sub - Vastus arthrotomy |
| Mid - Vastus arthrotomyMid-vastus arthrotomy | Procedure or surgery | Mid-Vastus arthrotomy |
Primary outcome
VAS, KOOS and HSS scales
Time frame: at day 1, day 2, day 3, day 4 and day 5 post-operatively
Rehabilitation time; time needed for 90° flexion of the knee joint
Time frame: post-operatively
2 secondary outcomes
VAS, HSS, KOOS questionnaires
Time frame: at 6 weeks, 3 months and 12 months after surgery.
Amount and type of analgesic drugs used.
Time frame: pre-operatively and post-operatively
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 7 Jul 2021.
- website of the University Hospital GhentLink provided by the sponsor.
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.
Peter Verdonk, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sub-Vastus arthrotomy and Mid - Vastus arthrotomy in people with Tricompartmental Gonarthrosis, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 2 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 7 Jul 2021. 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 Belgium. 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.
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?
VAS, KOOS and HSS scales (time frame: at day 1, day 2, day 3, day 4 and day 5 post-operatively). 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 7 Jul 2021.