NCT07755085

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
26mo left

Started Oct 2026

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1.7 years

First QC Date

August 3, 2026

Last Update Submit

August 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    90 days

Secondary Outcomes (10)

  • Body weight

    6 months

  • Body composition analysis by DEXA

    6 months

  • Gait

    1 year

  • Patient reported outcome measures - Joint function

    1 year

  • Patient reported outcome measure - Quality of Life

    1 year

  • +5 more secondary outcomes

Other Outcomes (2)

  • Return to work

    1 year

  • Surgery Delayed / Cancelled

    6 months

Study Arms (2)

Placebo Medication

PLACEBO COMPARATOR

Patients administered placebo medication for at least 6 months preoperatively

Behavioral: Behavioral + placebo

Study medication group

EXPERIMENTAL

Patients receive at least 6 months of study group medication preoperatively

Drug: GLP-1 Receptor Agonists + Behavioral modification

Interventions

At least 6 months of preoperative semaglutide and structured behavioural modification

Study medication group

Structured behavioural modification - diet, exercise, counselling and placebo medication

Placebo Medication

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Health

Dartmouth, Nova Scotia, B2Y 2N5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 38857711BACKGROUND

MeSH Terms

Conditions

ArthritisObesityOverweight

Interventions

Glucagon-Like Peptide-1 Receptor AgonistsBehavior Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypoglycemic AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Jhase Sniderman, MD, MSc, FRCSC, FAAOS

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon, MD, MSc, FRCSC, FAAOS

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 10, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

August 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Protocol, analysis can be shared upon request - no patient data will be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Start until end of trial
Access Criteria
Eligible researchers from academic institutions
More information

Locations