Clinical trial NCT06807970: Optimization of Obesity for Total Knee Replacement with Glucagon-like Peptide-1 Receptor Agonist
Official title: Novel Perioperative Optimization of Obese Osteoarthritic Patients Pending Total Knee Replacement with Glucagon-like Peptide-1 Receptor Agonist (NPO-OOPS-TKR)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Osteoarthritis (OA) of the Knee
Keywords: osteoarthritis
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 2.1 Hypothesis Hypothesis for this pilot trial is conducting trial of GLP-1RA for perioperative optimization for TKR feasible. The null hypothesis for the full trial is that clinical, functional and quality of life (QoL) outcomes in obese patients undergoing TKR will not be improved if this is preceded by GLP-1 RA induced weight loss.

3. Study objective The primary aims of this pilot study are 1) estimate adherence, tolerability and follow-up rates, 2) recruitment and management challenges.

The secondary aims are to assess the effect of semaglutide for perioperative optimization in TKR and gather data to estimate the feasibility like tolerability and sample size for a future trial.

Eligibility 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.

Primary outcomes:
measure: Pain
timeFrame: As 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.
Secondary outcomes:
measure: A composite score of clinical situation
timeFrame: As 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.
measure: Length of stay
timeFrame: As 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.
measure: Body weight
timeFrame: As 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.
measure: Radiological parameters
timeFrame: As 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.
measure: height
timeFrame: As 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.
measure: waist circumference
timeFrame: As 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.
measure: blood pressure
timeFrame: As 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.
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: As 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.
measure: The Knee Society Score
timeFrame: As 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.
Other outcomes:
Locations:
Study officials:
affiliation: The University of Hong Kong
name: Lawrence Lau, FRCS, PhD
role: PRINCIPAL_INVESTIGATOR
References: