Clinical trial

Optimization of Obesity for Total Knee Replacement With Glucagon-like Peptide-1 Receptor Agonist

Active, not recruiting · Early Phase 1 · 1 countries · Registry ID NCT06807970

Active, not recruitingEarly Phase 1Interventional

What this study is about

Studies have shown that obese patients undergoing total knee replacement (TKR) surgery face a higher risk of perioperative issues such as increased use of pain medication, surgical site infections, and the need for revision surgeries compared to non-obese patients. Obesity is also linked to more significant preoperative pain and lingering symptoms post-surgery. Consequently, there's a growing interest in weight loss interventions prior to TKR to enhance perioperative care and outcomes. Recent retrospective studies have indicated that such interventions can improve physical function post-TKR. Research focusing on weight loss interventions before joint replacement surgery is limited. There is currently a gap in research regarding RCTs on weight loss interventions using anti-obesity drugs before TKR, particularly in Asian populations. One promising avenue under exploration involves the use of glucagon-like peptide 1 receptor agonists (GLP-1RAs) as anti-obesity medication before total knee replacement (TKR) surgery. However, there are currently no randomized controlled trials (RCTs) examining the effects of GLP-1RAs on knee arthroplasty outcomes. Large database studies have indicated that GLP-1RAs may decrease the likelihood of certain post-surgery complications but increase the risk of others. In summary, addressing obesity through weight loss interventions, particularly with GLP-1RAs, holds promise for improving outcomes in TKR patients. However, further research, including randomized controlled trials, is necessary to fully understand the effects of GLP-1RAs on perioperative outcomes and patient health.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionOsteoarthritis (OA) of the Knee

Full registry criteria

Inclusion Criteria: * Age between 40 and 80 years old * BMI ≥27 kg/m2 * On the surgical waiting list for primary TKR * Willing and able to cooperate in a weight management programme. * Meeting indication for semaglutide Exclusion Criteria: * Revision surgery or surgery for neoplastic disease * A medical condition which in the opinion of the investigators makes the patient unsuitable for participation in the trial * Contraindication to GLP-1RA, like history of pancreatitis, severe gastrointestinal diseases such as gastroparesis, thyroid cancer, and inflammatory bowel disease * Lack of acceptance of the randomisation process.

Treatments and study arms

Glucagon-like peptide-1 receptor agonists (GLP 1 RA)

Drug

Patients in intervention group will have GLP-1RA semaglutide for 48 weeks and then stops for one month before and after TKR following the latest anesthesia guideline for GLP-1RA. Followed by TKR They will continue semaglutide for 48 weeks during the post-operative follow-up period. This is decided based on balancing treatment effect of semaglutide, waiting time for TKR, and TKR follow-up requirement. In Hong Kong, waiting time for TKR would be \~4 years and so a period of 12 months treatment of semaglutide is reasonable. And in the STEP 6 trial, weight loss at week 52 (-12%) is similar to that in study end at week 68(-13·2%), and STEP5 trial showed maintaining semaglutide to week 104 could maintain weight loss of similar degree as in week 52. And the consensus of assessing TKR Patient-Reported Outcome Measures (PROMs) is one year follow up.

Control (Standard treatment)

Other

If patients are randomized to the control group, they will receive routine follow-up with general advice on diet and physical activity but will not receive semaglutide, and will not be offered a specific management program for their weight. This is in line with current practice.

Primary outcomes

Visual analogue scale and analgesic consumptionAs part of the standard of care when undergoing TKR, patients are routinely assessed at enrolment, 1 month and same day before surgery, and at 6 weeks,3 months, 6 months and 12 months post-surgery.

Assess at enrolment, prior to and after TKR, and at each follow-up till 12 months. Pain is chosen as the primary outcome because up to 14 patients in weight loss groups (versus 2 patients in control groups) in previous studies chosen to decline/delay TKR due to pain relief, suggesting a prominent effect of weight optimization on pain relief. Pain is evaluated using two approaches. The first method is visual analog scale which involves the numeric rating scale, which ranges from 0 to 10, with 0 representing no pain and 10 representing the most intense pain. The second method involves monitoring analgesic consumption, with higher consumption indicating more severe pain.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Queen Mary Hospital🇭🇰 Hong Kong, Pokfulam, Hong Kong

Open map