ArthritisPhase 4NCT07755085
GLP-1s in Hip and Knee Arthroplasty
A Phase 4 study testing GLP-1 Receptor Agonists + Behavioral modification in people with Arthritis and Obesity & Overweight, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arthritis, Obesity & Overweight, GLP - 1
- What is being tested?
- GLP-1 Receptor Agonists + Behavioral modification
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2026to Dec 2028
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of hip or knee arthritis and are a deemed candidate for THA or TKA by an orthopaedic surgeon
- Diagnosis of BMI 35+ with an obesity-related health condition (Coronary vascular disease, previous stroke, type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, asthma) or BMI 40+
- Patients must be between 18-90 years of age
- Able to provide informed consent
Who cannot join
- Cognitive impairment that precludes study participation and compliance
- Patients unwilling to undergo smoking cessation prior to surgery
- Patients currently taking biologic medications that suppress the immune system
- Patients currently taking GLP-1 medications
- Patients with a contraindication to GLP-1 medication
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
Nova Scotia Health
Dartmouth, Nova Scotia, B2Y 2N5
Jhase Sniderman, MD,MSc, FRSCS, FAAOS, 9029323130, jhase.sniderman@nshealth.ca
About this study
Official title: Does the Preoperative Use of GLP-1 Agonists Change Outcomes in Patients Waiting for Total Hip and Knee Arthroplasty: A Pilot Randomized Control Trial
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.
Read the detailed description
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.
- Conditions
- Arthritis, Obesity & Overweight, GLP - 1
- Being tested
- GLP-1 Receptor Agonists + Behavioral modification, Behavioral + placebo
- Medical subject headings
- Arthritis, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 Receptor Agonists + Behavioral modificationDrug
At least 6 months of preoperative semaglutide and structured behavioural modification
Behavioral + placeboBehavioural
Structured behavioural modification - diet, exercise, counselling and placebo medication
| Study group | Role | What they receive |
|---|---|---|
| Placebo Medication | Placebo comparator | Patients administered placebo medication for at least 6 months preoperatively Receives: Behavioral: Behavioral + placebo |
| Study medication group | Experimental | Patients receive at least 6 months of study group medication preoperatively Receives: Drug: GLP-1 Receptor Agonists + Behavioral modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 90 days
Secondary outcomes (10)
Body weight
To evaluate and compare weight loss as a percentage of body weight (kilograms) prior to THA or TKA
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
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 posted10 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Innovation Centre, Dalhousie University, University of Manitoba
- Responsible party
- Principal investigator, Jhase Sniderman, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755085
- Sponsor's protocol ID
- GLP1
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol, analysis can be shared upon request - no patient data will be shared.
Publications
Lavu MS, Porto JR, Hecht CJ 2nd, Kaelber DC, Sculco PK, Heckmann ND, Kamath AF. The Five-Year Incidence of Progression to Osteoarthritis and Total Joint Arthroplasty in Patients Prescribed Glucagon-Like Peptide 1 Receptor Agonists. J Arthroplasty. 2024 Oct;39(10):2433-2439.e1. doi: 10.1016/j.arth.2024.06.008. Epub 2024 Jun 8.
PubMed 38857711
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Preoperative Use of GLP-1 Agonists Change Outcomes in Patients Waiting for Total Hip and Knee Arthroplasty: A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07755085
- Acronym / sponsor ID
- GLP1
- Conditions
- Arthritis, Obesity & Overweight, GLP - 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Orthopaedic Innovation Centre, Dalhousie University, University of Manitoba
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Aug 2026 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Placebo Medication | Placebo comparator | Behavioral: Behavioral + placeboPatients administered placebo medication for at least 6 months preoperatively |
| Study medication group | Experimental | Drug: GLP-1 Receptor Agonists + Behavioral modificationPatients receive at least 6 months of study group medication preoperatively |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a diagnosis of hip or knee arthritis and are a deemed candidate for THA or TKA by an orthopaedic surgeon
- Diagnosis of BMI 35+ with an obesity-related health condition (Coronary vascular disease, previous stroke, type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, asthma) or BMI 40+
- Patients must be between 18-90 years of age
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Cognitive impairment that precludes study participation and compliance
- Patients unwilling to undergo smoking cessation prior to surgery
- Patients currently taking biologic medications that suppress the immune system
- Patients currently taking GLP-1 medications
- Patients with a contraindication to GLP-1 medication
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 |
|---|---|---|
| GLP-1 Receptor Agonists + Behavioral modificationAt least 6 months of preoperative semaglutide and structured behavioural modification | Drug | Study medication group |
| Behavioral + placeboStructured behavioural modification - diet, exercise, counselling and placebo medication | Behavioural | Placebo Medication |
Primary outcome
Incidence of Wound Complication after Joint Arthroplasty
Time frame: 90 days
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)
10 secondary outcomes
Body weight
Time frame: 6 months
Body composition analysis by DEXA
Time frame: 6 months
Gait
Time frame: 1 year
Patient reported outcome measures - Joint function
Time frame: 1 year
Patient reported outcome measure - Quality of Life
Time frame: 1 year
Patient reported outcome measure - Patient Satisfaction
Time frame: 1 year
Incidence of Superficial wound infections
Time frame: 1 year
Incidence of deep periprosthetic infections
Time frame: 1 year
Adverse Events
Time frame: 9 months
Surgical Complications
Time frame: 1 year
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 10 Aug 2026.
- Background: PubMed 38857711Lavu MS, Porto JR, Hecht CJ 2nd, Kaelber DC, Sculco PK, Heckmann ND, Kamath AF. The Five-Year Incidence of Progression to Osteoarthritis and Total Joint Arthroplasty in Patients Prescribed Glucagon-Like Peptide 1 Receptor Agonists. J Arthroplasty. 2024 Oct;39(10):2433-2439.e1. doi: 10.1016/j.arth.2024.06.008. Epub 2024 Jun 8.
- Individual participant dataSharing planned: Yes. Protocol, analysis can be shared upon request - no patient data will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GLP-1 Receptor Agonists + Behavioral modification in people with Arthritis and Obesity & Overweight, run by Nova Scotia Health Authority 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 4 inclusion and 5 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 10 Aug 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jhase Sniderman, MD, MSc, FRCSC, FAAOS (9029323130, jhase.sniderman@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Wound Complication after Joint Arthroplasty (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07755085, which also lists 1 linked publication.
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 10 Aug 2026.