Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis

Status Completed

Clinical Trial Summary

The primary purpose of this study is to evaluate laparoscopic gastric banding (LAGB) surgery as a treatment option for obese patients with pain from knee osteoarthritis (KOA) refractory to medical treatment. The primary outcome will be the reduction in OA-related pain and disability after LAGB.

Clinical Trial Description

This is a pilot study of 15 (may need to consent/screen 30 patients to have 15 enrolled) obese patients (BMI 30-40) with painful knee osteoarthritis. Although prior studies have reported musculoskeletal secondary outcomes following various types of bariatric surgery, investigators propose the evaluation of laparoscopic gastric banding (LAGB) to treat a cohort of patients with moderate to severe knee osteoarthritis.

Once eligible patients are identified by rheumatologists and/or bariatric team and consented for the study, they will have bilateral knee radiographs (standard of care) to ensure they have a sufficient degree of OA. Patients will then be referred to the bariatric surgeons, who will then confirm the patients' interest, understanding and suitability for the LAGB surgery which is a FDA approved procedurefor patients with a BMI >30 and at least one obesity-related comorbidity (including knee OA)37. It is the application of this approved procedure that constitutes the research question should LAGB surgery be considered as a treatment option to improve pain and physical disability in patients with knee OA? During the pre-operative process patients will be given study questionnaires to evaluate knee pain and function, have a musculoskeletal exam and blood/urine will be collected.These procedures will be repeated at post-operative intervals to track response of the knees to the LAGB.

The primary outcome measure is improvement in OA-related knee pain and physical disability. Improvement of pain and function will be defined by changes in the VAS, WOMAC, AORC and KOOS scores. The degree of improvement required to qualify as such will be described in the methods sections below.

Secondary outcome measures include (1) radiographic evidence of OA progression or worsening despite the LABG, (2) weight loss, and (3) reduction or discontinuation of pain medication. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02272218
Study type	Interventional
Source	NYU Langone Health
Contact
Status	Completed
Phase	N/A
Start date	October 23, 2012
Completion date	October 18, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04651673` - Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Completed	`NCT05677399` - Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.	N/A
Active, not recruiting	`NCT04043819` - Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis	Phase 1
Recruiting	`NCT06000410` - A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee	Phase 3
Completed	`NCT05014542` - Needling Techniques for Knee Osteoarthritis	N/A
Recruiting	`NCT05892133` - Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty	N/A
Recruiting	`NCT05528965` - Parallel Versus Perpendicular Technique for Genicular Radiofrequency	N/A
Active, not recruiting	`NCT03472300` - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Active, not recruiting	`NCT02003976` - A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone	N/A
Active, not recruiting	`NCT04017533` - Stability of Uncemented Medially Stabilized TKA	N/A
Completed	`NCT04779164` - The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis	N/A
Recruiting	`NCT04006314` - Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis	N/A
Recruiting	`NCT05423587` - Genicular Artery Embolisation for Knee Osteoarthritis II	N/A
Enrolling by invitation	`NCT04145401` - Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Active, not recruiting	`NCT03781843` - Effects of Genicular Nerve Block in Knee Osteoarthritis	N/A
Completed	`NCT05974501` - Pre vs Post Block in Total Knee Arthroplasty (TKA)	Phase 4
Completed	`NCT05324163` - Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis	Phase 3
Completed	`NCT05529914` - Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis	N/A
Recruiting	`NCT05693493` - Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?	N/A
Not yet recruiting	`NCT05510648` - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.