Osteoarthritis of KneeNCT06767787
Morbid Obesity and Severe Knee Osteoarthritis - Which Should Be Treated First?
A study testing laparoscopic sleeve gastrectomy and total knee arthroplasty in people with Osteoarthritis of Knee and Arthroplasties, Knee Replacement, run by Memorial University of Newfoundland at 2 sites in Canada.
Trial summary
The goal of this study is to determine whether undergoing bariatric surgery before knee replacement leads to better outcomes compared to undergoing knee replacement before bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis of Knee, Arthroplasties, Knee Replacement, Sleeve Gastrectomy
- What is being tested?
- laparoscopic sleeve gastrectomy and total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > or = 35, on surgical waitlist for a total knee arthroplasty and laparoscopic sleeve gastrectomy
Who cannot join
- a history of revision surgery, surgery for neoplastic disease, significant mental illness, ASA class > 3 denoting absence of significant impact of comorbidities, and previous esophagogastric surgery.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B3X5
Daniel G Muller, MD, MHSc, 6472271629, dmuller@mun.ca
Jack A Kerr, MD, 506-608-5005, jamkerr@mun.ca
St. Clare's Mercy Hospital
St. John's, Newfoundland and Labrador, A1C5B8
Jack A Kerr, MD, 506-608-5005, jamkerr@mun.ca
Daniel G Muller, MD, MHSc, 647-227-1629, dmuller@mun.ca
About this study
Official title: Morbid Obesity and Severe Knee Osteoarthritis - Which Should Be Treated First? A Randomized Cross-over Study
The goal of this study is to determine whether undergoing bariatric surgery before knee replacement leads to better outcomes compared to undergoing knee replacement before bariatric surgery. Our secondary goal is to compare complication rates between these groups to determine if there is a difference based on the order of the two procedures.
Participants will be randomly placed in one of two groups, with each undergoing both procedures but in opposite order. Quality of life will be assessed via questionnaires before and between each procedure, and rates of complications will also be documented to compare their rates between groups.
- Being tested
- laparoscopic sleeve gastrectomy, total knee arthroplasty
- Keywords
- knee osteoarthritis, bariatric surgery, laparoscopic sleeve gastrectomy, knee replacement, knee arthroplasty, obesity
- Medical subject headings
- Osteoarthritis, Knee, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sleeve gastrectomyProcedure or surgery
Also called bariatric surgery, sleeve gastrectomy
Participants undergoing laparoscopic sleeve gastrectomy (LSG) will be clinically assessed and provided consent to this procedure by one of the bariatric surgeons affiliated with the bariatric surgery program. LSG will be performed at a local tertiary care hospital as either a day procedure or as an overnight stay if medically indicated. Patients will be discharged once they can tolerate a liquid diet. Patients will then attend regular follow-ups with their surgeons and the bariatric surgery program, in accordance with a standardized clinical pathway protocol.
total knee arthroplastyProcedure or surgery
Also called knee arthroplasty, knee replacement
Patients undergoing unilateral total knee arthroplasty (TKA) will be clinically assessed and provided consent to their procedure by an orthopaedic surgeon trained in joint arthroplasty. TKA will be performed at a local tertiary care hospital as either a day procedure or as an overnight stay if medically indicated. Patients will be discharged once physiotherapy clears them. Patients will attend regular follow-ups with their surgeon in accordance with a standardized clinical pathway protocol.
| Study group | Role | What they receive |
|---|---|---|
| Sleeve Gastrectomy then Knee Arthroplasty | Active comparator | Participants in this arm will undergo laparoscopic sleeve gastrectomy followed by a total knee arthroplasty at least 1 year following the first procedure. Receives: Procedure: laparoscopic sleeve gastrectomy; Procedure: total knee arthroplasty |
| Knee Arthroplasty then Sleeve Gastrectomy | Active comparator | Participants in this arm will undergo total knee arthroplasty followed by laparoscopic sleeve gastrectomy at least 1 year following the first procedure. Receives: Procedure: laparoscopic sleeve gastrectomy; Procedure: total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 Physical Function Component Score
The 36-Item Short-Form Survey (SF-36) Physical Function Component Score will be assessed 1 year after each procedure as a measure of quality of life.
Measured: At baseline/enrollment followed by a year following each procedure.
Secondary outcomes (4)
SF-36 Mental Component Score
The 36-Item Short Form Survey's (SF-36) Mental Component Score will be used to assess participants' quality of life at baseline in addition to after each procedure.
Measured: At baseline/enrolment followed by a year after each procedure
Knee Osteoarthritis Outcome Score (KOOS)
The KOOS will be used to assess knee-specific function and symptoms at baseline as well as after each procedure.
Measured: At baseline/enrolment in addition to a year following each procedure
Post-Operative Outcomes
Post-operative outcomes following each intervention will be collected, including: hospital bed-day utilization, change in BMI and weight at 12 and 24 months.
Measured: At 12 and 24 months following each intervention
Post-Operative Complications
Post-operative complications will be surveilled every 3 months following each procedure, including: death from any cause, perioperative or postoperative complications that result in a delay in discharge (e.g., fracture, neurapraxia, sepsis, nosocomial infection, myocardial infarction, bowel obstruction, postoperative nausea \& vomiting, venous thromboembolism, cerebrovascular event, and renal failure), wound complications (e.g., infections, hematomas, and dehiscence), prosthetic infection, and unplanned procedures and/or readmission.
Measured: Surveilled every 3 months post- each procedure, until the 12-month postoperative mark.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nick Smith, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767787
- Sponsor's protocol ID
- HREB Application No. 38151
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbid Obesity and Severe Knee Osteoarthritis - Which Should Be Treated First? A Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT06767787
- Acronym / sponsor ID
- HREB Application No. 38151
- Keywords
- knee osteoarthritis, bariatric surgery, laparoscopic sleeve gastrectomy, knee replacement, knee arthroplasty, obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- 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 goal of this study is to determine whether undergoing bariatric surgery before knee replacement leads to better outcomes compared to undergoing knee replacement before bariatric surgery. Our secondary goal is to compare complication rates between these groups to determine if there is a difference based on the order of the two procedures.
Participants will be randomly placed in one of two groups, with each undergoing both procedures but in opposite order. Quality of life will be assessed via questionnaires before and between each procedure, and rates of complications will also be documented to compare their rates between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeve Gastrectomy then Knee Arthroplasty | Active comparator | Procedure: laparoscopic sleeve gastrectomy, Procedure: total knee arthroplastyParticipants in this arm will undergo laparoscopic sleeve gastrectomy followed by a total knee arthroplasty at least 1 year following the first procedure. |
| Knee Arthroplasty then Sleeve Gastrectomy | Active comparator | Procedure: laparoscopic sleeve gastrectomy, Procedure: total knee arthroplastyParticipants in this arm will undergo total knee arthroplasty followed by laparoscopic sleeve gastrectomy at least 1 year following the first procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI > or = 35, on surgical waitlist for a total knee arthroplasty and laparoscopic sleeve gastrectomy
Key exclusion criteria (1 listed)
- a history of revision surgery, surgery for neoplastic disease, significant mental illness, ASA class > 3 denoting absence of significant impact of comorbidities, and previous esophagogastric 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 |
|---|---|---|
| laparoscopic sleeve gastrectomyAlso: bariatric surgery, sleeve gastrectomyParticipants undergoing laparoscopic sleeve gastrectomy (LSG) will be clinically assessed and provided consent to this procedure by one of the bariatric surgeons affiliated with the bariatric surgery program. LSG will be performed at a local tertiary care hospital as either a day procedure or as an overnight stay if medically indicated. Patients will be discharged once they can tolerate a liquid diet. Patients will then attend regular follow-ups with their surgeons and the bariatric surgery program, in accordance with a standardized clinical pathway protocol. | Procedure or surgery | Knee Arthroplasty then Sleeve Gastrectomy, Sleeve Gastrectomy then Knee Arthroplasty |
| total knee arthroplastyAlso: knee arthroplasty, knee replacementPatients undergoing unilateral total knee arthroplasty (TKA) will be clinically assessed and provided consent to their procedure by an orthopaedic surgeon trained in joint arthroplasty. TKA will be performed at a local tertiary care hospital as either a day procedure or as an overnight stay if medically indicated. Patients will be discharged once physiotherapy clears them. Patients will attend regular follow-ups with their surgeon in accordance with a standardized clinical pathway protocol. | Procedure or surgery | Knee Arthroplasty then Sleeve Gastrectomy, Sleeve Gastrectomy then Knee Arthroplasty |
Primary outcome
SF-36 Physical Function Component Score
Time frame: At baseline/enrollment followed by a year following each procedure.
The 36-Item Short-Form Survey (SF-36) Physical Function Component Score will be assessed 1 year after each procedure as a measure of quality of life.
4 secondary outcomes
SF-36 Mental Component Score
Time frame: At baseline/enrolment followed by a year after each procedure
Knee Osteoarthritis Outcome Score (KOOS)
Time frame: At baseline/enrolment in addition to a year following each procedure
Post-Operative Outcomes
Time frame: At 12 and 24 months following each intervention
Post-Operative Complications
Time frame: Surveilled every 3 months post- each procedure, until the 12-month postoperative mark.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis of Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic sleeve gastrectomy and total knee arthroplasty in people with Osteoarthritis of Knee and Arthroplasties, Knee Replacement, run by Memorial University of Newfoundland at 2 sites 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 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: opening soon, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel G Muller, MD (647-227-1629, dmuller@mun.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 Physical Function Component Score (time frame: At baseline/enrollment followed by a year following each procedure.). 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 30 Jan 2025.