A Phase 4 interventional study of GLP-1 Receptor Agonists + Behavioral modification and Behavioral + placebo in Arthritis, Obesity & Overweight and GLP - 1, sponsored by Nova Scotia Health Authority. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Nova Scotia Health Authority · Phase 4, Interventional, and Treatment
The number of people living with hip and knee arthritis continues to grow. A large amount of these people are also overweight and diagnosed with obesity. Obesity leads to more stress on hip and knee joints, causing them to wear out sooner. This process is called arthritis. When arthritis gets worse, the joints often need to be replaced due to pain and poor mobility. Very heavy patients often have other health problems that can impair the ability to manage arthritis. Excess weight and health problems can change the way heavy patients recover after surgery, leading to a greater risk of complications. A new type of medicine might be able to improve how obese patients manage their hip and knee pain, as well as improve outcomes after surgery. This type of medicine is called a GLP-1. Investigators will study 2 groups, with one receiving the medicine while the other does not. The goal is to understand how these medications work in the time leading up to surgery and in the early postoperative recovery phase. If these medications help, it may improve the care of high risk obese patients.
Approximately 35% of adults in North America are now classified as obese (BMI >30), with the fastest growing proportion of these being those with a BMI > 40. While BMI cut-offs at one point existed, there is now little evidence that total joint arthroplasty should be withheld from these patients. Withholding surgery does not incentivize weight loss and creates inequities in access to healthcare. As practice patterns change, it is expected that more individuals with a BMI > 40 and even >50 will undergo total hip or knee replacement in the coming years. The perioperative risks associated with an elevated BMI at the time of arthroplasty have been established. There are a greater risk of wound complications, infection, reoperation and other perioperative medical complications. Patient education, counselling, nutrition optimization via a dietician and exercise remain the first line options for achieving weight loss. Recently, GLP-1 receptor agonist medications have become common as a treatment strategy for weight loss. While the role of bariatric surgery has been studied extensively, little is known about the influence of GLP-1 agonists on patients planned for joint arthroplasty. The hypothesis is that administering a GLP-1agonist preoperatively will help aid in preoperative weight loss, body composition, gait and patient reported outcome measures (PROMs). Similarly, it is thought that GLP-1s will help mitigate acute postoperative complications and lead to improved PROMs.
A pilot randomized control trial will be conducted at two high-volume tertiary orthopaedic subspecialty hospitals that routinely treats patients with class 3 and class 4 obesity. Patients who are candidates for total hip or knee arthroplasty will be randomly allocated to receive either the standard of care (counselling, patient education, dietician referral, exercise prescription) with placebo or the standard of care and a prescription for a GLP-1 agonist. Both groups will have surgery after 6 months of treatment initiation, allowing for optimization of body weight. The primary outcome is wound complications requiring antibiotics, debridement or a return to the operating room within 90 days. Secondary outcomes are weight loss, body composition, bone density, gait analysis, decision to no longer have surgery (i.e remove themselves from the waitlist), time to return to work, deep periprosthetic joint infections within 90 days and 1 year; Oxford Hip Score, Oxford Knee Score, EQ-5D-5L, satisfaction and other perioperative complications.
There is an expected wound complication rate of between 3-5% in patients with class 3 and 4 obesity. A pilot study based on 5% of the total sample size needed to adequately power a full trial would represent 50 patients in each group. Dependent on the pilot study, a full study of 568 patients could be conducted.
The use of GLP-1 agonists as a tool within a medically supervised weight loss program is growing rapidly. Their influence on the outcomes of total hip and knee arthroplasty is still largely unknown and warrants structured and rigorous investigation.
843 studies on the registry are indexed under Arthritis; 118 are open to participants now.
This study's planned enrollment of 100 is close to the median of 97 across 599 interventional studies indexed under Arthritis.
Browse Arthritis studies →Nova Scotia Health Authority is the lead sponsor of 264 studies on the registry; 79 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients administered placebo medication for at least 6 months preoperatively
Behavioral: Behavioral + placebo
Patients receive at least 6 months of study group medication preoperatively
Drug: GLP-1 Receptor Agonists + Behavioral modification
Drug page: GLP-1 receptor agonists
At least 6 months of preoperative semaglutide and structured behavioural modification
Structured behavioural modification - diet, exercise, counselling and placebo medication
This study also gives Semaglutide. No intervention listed here names it: that was found by reading the record.
Incidence of Wound Complication after Joint Arthroplasty
To determine whether the preoperative administration of a GLP-1 receptor agonist impacts the incidence of wound complications in patients with class 3 or 4 obesity that require either antibiotics, in clinic debridement or a return to the operating room within 90 days of THA or TKA (Yes/No)
Time frame: 90 days
Body weight
To evaluate and compare weight loss as a percentage of body weight (kilograms) prior to THA or TKA
Time frame: 6 months
Body composition analysis by DEXA
To evaluate and compare body composition (fat mass / lean mass) determined by DEXA prior to THA or TKA
Time frame: 6 months
Gait
To evaluate how gait changes prior to THA or TKA and postoperatively via markerless motion capture - composite gait speed, gait symmetry, cadence, step length, stance-time symmetry and joint specific flexion extension
Time frame: 1 year
Patient reported outcome measures - Joint function
To evaluate patient reported outcomes related to joint function the Oxford Scoring System will be used (Oxford Hip and Knee Score) preoperatively as well as at 6 weeks, 6 months and 1 year of THA or TKA. Oxford hip and knee scores are measured 0-48 with 0 being the worst joint problem and 48 being no joint problem.
Time frame: 1 year
Patient reported outcome measure - Quality of Life
To evaluate patient reported outcomes related to quality of life, the EQ-5D-5L survey will be used. The EQ-5D-5L score evaluates health-related quality of life across five dimensions using five severity levels. It yields an index value (ranging from below 0 (death) to 1.0 for full health), and a 0-100 score (0 is the worst imaginable and 100 is the best health).
Time frame: 1 year
Patient reported outcome measure - Patient Satisfaction
To evaluate patient satisfaction, a survey will be used and graded 0-2 (0 is not satisfied, 2 is satisfied)
Time frame: 1 year
Incidence of Superficial wound infections
To evaluate the incidence of superficial infections including wound drainage, cellulitis, or infections superficial to the deep fascia within 1 year following THA or TKA (Yes/No)
Time frame: 1 year
Incidence of deep periprosthetic infections
To evaluate the incidence of deep periprosthetic infections within 90 days and 1 year of THA or TKA
Time frame: 1 year
Adverse Events
To monitor the cumulative incidence of adverse events in patients administered GLP-1 agonists versus standard of care in patients undergoing THA or TKA.
Time frame: 9 months
Surgical Complications
To monitor the incidence of surgical complications within 1 year of THA or TKA. Composite measure of cumulative dislocation, fracture, knee manipulation, infection, instability, DVT/PE
Time frame: 1 year
Return to work
In patients that are/were employed and intending to still work - what is the time to return to work.
Time frame: 1 year
Surgery Delayed / Cancelled
In patients that were previously consented for THA or TKA - how many would postpone their surgery due to preoperative improvement.
Time frame: 6 months
Plan to share: Yes — Protocol, analysis can be shared upon request - no patient data will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Start until end of trial
Access criteria: Eligible researchers from academic institutions
Data sharing details ↗ · orthoinno.com
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: GLP-1 receptor agonists · Semaglutide
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