Knee OsteoarthritisOMEOSKONCT05120492
Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial
A study testing bariatric surgery followed by total knee replacement in people with Knee Osteoarthritis and Morbid Obesity, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Does weight loss surgery in patients with morbid obesity prior to knee replacement surgery improve outcomes from knee replacement surgery Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Morbid Obesity
- What is being tested?
- bariatric surgery followed by total knee replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 22 Apr 2022to Jul 2027
- Phase
- Interventional
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- severe knee osteoarthritis body-mass index of 45 to 60
Who cannot join
- previous total replacement of the same knee, a need for bilateral total knee replacement, and knee pain during the previous week that the patient rated at higher than 60 mm on a 100-mm visual-analogue scale. Also,prior bariatric or complex foregut surgery, significant cardiovascular, pulmonary, renal, liver, gastrointestinal, psychiatric disorders, pregnancy, malignancy within last 5 years, anemia, coagulopathy requiring anti-coagulation therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Nova Scotia Health
Halifax, Nova Scotia, B4E 0H4
James Ellsmere, MD, 902-473-1886, JELLSMER@DAL.CA
About this study
Does weight loss surgery in patients with morbid obesity prior to knee replacement surgery improve outcomes from knee replacement surgery
Read the detailed description
RCT involving patients who have severe knee osteoarthritis and have a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 45 to 60 and are randomly assigned to receive dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (control arm) or sleeve gastrectomy with dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (treatment arm).
- Conditions
- Knee Osteoarthritis, Morbid Obesity
- Being tested
- bariatric surgery followed by total knee replacement
- Keywords
- Arthroplasty, Replacement, Knee, Bariatric Surgery
- Medical subject headings
- Osteoarthritis, Knee, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgery followed by total knee replacementProcedure or surgery
The only intervention is the randomization of the priority of the 2 procedures.
| Study group | Role | What they receive |
|---|---|---|
| Surgical weight loss | Experimental | sleeve gastrectomy + dietary and lifestyle counseling prior to total knee replacement Receives: Procedure: bariatric surgery followed by total knee replacement |
| Standard of Care | No intervention | dietary and lifestyle counseling prior to total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, mobility and quality of Life
Knee Injury and Osteoarthritis Outcome Score (KOOS4)
Measured: 1 year
Secondary outcomes (1)
EuroQol Group 5-Dimension Self Report Questionnaire (EQ-5D)
assessing quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start22 Apr 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120492
- Sponsor's protocol ID
- 41155
- Acronym
- OMEOSKO
- Status last verified
- Aug 2024
- First submitted
- 3 Nov 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No