Medial Compartment Osteoarthritis of the KneeNCT01614288
High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint
A study testing knee Arthroscopy and No arthroscopy in people with Medial Compartment Osteoarthritis of the Knee, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
Participants will be randomized to undergo a High Tibial Osteotomy (HTO) with or without a knee scope. Patients will be tested in the Gait Lab, will fill out quality-of-life questionnaires, and have a clinical evaluation done preoperative and at each follow-up visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medial Compartment Osteoarthritis of the Knee
- What is being tested?
- knee Arthroscopy and No arthroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients booked for an HTO due to OA
- Grades II to IV severity of OA by radiographic evaluation (Kellgren \& Lawrence grade)
- OA of the knee primarily involving the medial compartment
Who cannot join
- Imaging evidence of significant knee joint pathology that would change the decision to do an HTO
- An arthroscopy of the knee within 2 years of planned surgery
- Active joint or systemic infection,
- Major medical illness that would preclude undergoing surgery,
- Patients who are unwilling or unable to be assessed according to study protocol for two years following surgery
- Major psychiatric illness, developmental handicap or inability to read and understand the English language
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre - University Hospital
London, Ontario
About this study
Official title: A Randomized Clinical Trial to Compare the Effectiveness of High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint on Quality of Life, Function, Pain and Swelling for Patients With Medical Compartment Osteoarthritis of the Knee
Participants will be randomized to undergo a High Tibial Osteotomy (HTO) with or without a knee scope. Patients will be tested in the Gait Lab, will fill out quality-of-life questionnaires, and have a clinical evaluation done preoperative and at each follow-up visit.
- Being tested
- knee Arthroscopy, No arthroscopy
- Keywords
- HTO, Arthroscopy, Quality-of-Life, Gait Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knee ArthroscopyProcedure or surgery
Patient undergoes a knee arthroscopy and HTO
No arthroscopyOther
Patient undergoes an HTO without knee arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| Knee Arthroscopy + HTO | Active comparator | Not described Receives: Procedure: knee Arthroscopy |
| HTO Alone | Active comparator | Not described Receives: Other: No arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
Measured: Preoperatively; 3, 6, 12, 18 and 24 months
Secondary outcomes (4)
The Lower Extremity Functional Scale (LEFS)
Measured: Preoperatively; 3, 6, 12, 18 and 24 months
Patient Diary to asses swelling, pain and frequency of analgesic and NSAID use.
Measured: Daily x 2 weeks post surgery; Weekly x 3 months
SF-12
Measured: Preoperatively; 3, 6, 12, 18 and 24 months
Gait Testing Procedures
Measured: 6, 12 and 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Compartment 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dianne Bryant, University of Western Ontario, Canada
- Investigators
- Dianne Bryant, PhD, Study director, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614288
- Sponsor's protocol ID
- FKSMC 2010 - 2
- Status last verified
- Feb 2013
- First submitted
- 4 Jun 2012
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Compare the Effectiveness of High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint on Quality of Life, Function, Pain and Swelling for Patients With Medical Compartment Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01614288
- Acronym / sponsor ID
- FKSMC 2010 - 2
- Keywords
- HTO, Arthroscopy, Quality-of-Life, Gait Analysis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- First posted
- 7 Jun 2012 (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.
Participants will be randomized to undergo a High Tibial Osteotomy (HTO) with or without a knee scope. Patients will be tested in the Gait Lab, will fill out quality-of-life questionnaires, and have a clinical evaluation done preoperative and at each follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Arthroscopy + HTO | Active comparator | Procedure: knee Arthroscopy |
| HTO Alone | Active comparator | Other: No arthroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients booked for an HTO due to OA
- Grades II to IV severity of OA by radiographic evaluation (Kellgren \& Lawrence grade)
- OA of the knee primarily involving the medial compartment
Key exclusion criteria (6 listed)
- Imaging evidence of significant knee joint pathology that would change the decision to do an HTO
- An arthroscopy of the knee within 2 years of planned surgery
- Active joint or systemic infection,
- Major medical illness that would preclude undergoing surgery,
- Patients who are unwilling or unable to be assessed according to study protocol for two years following surgery
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 |
|---|---|---|
| knee ArthroscopyPatient undergoes a knee arthroscopy and HTO | Procedure or surgery | Knee Arthroscopy + HTO |
| No arthroscopyPatient undergoes an HTO without knee arthroscopy | Other | HTO Alone |
Primary outcome
WOMAC
Time frame: Preoperatively; 3, 6, 12, 18 and 24 months
4 secondary outcomes
The Lower Extremity Functional Scale (LEFS)
Time frame: Preoperatively; 3, 6, 12, 18 and 24 months
Patient Diary to asses swelling, pain and frequency of analgesic and NSAID use.
Time frame: Daily x 2 weeks post surgery; Weekly x 3 months
SF-12
Time frame: Preoperatively; 3, 6, 12, 18 and 24 months
Gait Testing Procedures
Time frame: 6, 12 and 24 months post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
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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.
Dianne Bryant, PhD study director
The University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing knee Arthroscopy and No arthroscopy in people with Medial Compartment Osteoarthritis of the Knee, run by University of Western Ontario, Canada 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 3 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: withdrawn, as of the sponsor's last update on 8 Feb 2013. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
WOMAC (time frame: Preoperatively; 3, 6, 12, 18 and 24 months). 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 8 Feb 2013.