Health TrialsbyHealthPanel

GLP-1s in Hip and Knee Arthroplasty

ConditionsArthritisObesity & OverweightGLP - 1
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNova Scotia Health Authority

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • GLP-1 Receptor Agonists + Behavioral modification

    Drug

    At least 6 months of preoperative semaglutide and structured behavioural modification

  • Behavioral + placebo

    Behavioral

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Placebo MedicationPlacebo comparator 1 intervention
Group B: Study medication groupExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
90 days

Secondary outcomes

1

Body weight

To evaluate and compare weight loss as a percentage of body weight (kilograms) prior to THA or TKA

Time frame
6 months
2

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
3

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
4

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

Other outcomes

1

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
2

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nova Scotia Health Authority

Lead sponsor

Orthopaedic Innovation Centre

Collaborator

Dalhousie University

Collaborator

University of Manitoba

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: