Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis

NCT02272218 | Completed

• 1 other identifier: 12-03313
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• reduction in OA-related pain and disability after LAGB.

  questionnaires will be distributed pre- and post-surgery.

  4 years

Study Arms (1)

LAGB

OTHER

There is only one arm for this study, since this study involves a single cohort receiving the same intervention, laparoscopic gastric banding (LAGB) surgery.

Procedure: bariatric lap band surgery

Interventions

bariatric lap band surgery PROCEDURE

The intervention in this study is laparoscopic gastric banding (LAGB) surgery as a treatment option for obese patients with pain from knee osteoarthritis (KOA) refractory to medical treatment

LAGB

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able and willing to provide written informed consent
• at least 25 years of age
• body mass index (BMI) between 30 and 40 (FDA-approved BMI window for LAGB surgery if there is at least one comorbidity)
• pain in at least one knee for 15 of the 30 days prior to screening
• clinically diagnosed with knee OA using American College of Rheumatology (ACR) criteria.
• Patient pain visual analog scale (VAS) ≥40
• pain not controlled with Tylenol, NSAIDs or topical therapy (or unable to use/tolerate NSAIDs for medical reasons)
• anterior-posterior (AP) radiograph of at least one knee with Kellgren-Lawrence (K-L) grading scale ≥ 2 (moderate to severe osteoarthritis)

You may not qualify if:

• unable to provide written informed consent
• less than 25 yrs of age
• BMI \<30 or \>40
• does not fulfill the ACR criteria for OA
• VAS \<40
• any clinical disorder requiring use of corticosteroids within one week of visit
• viscosupplementation or intra-articular steroid injection to the affected knee within the prior one month
• bilateral total knee replacement
• has not yet tried to treat pain with oral NSAIDs/COX-2 inhibitors (unless medical contraindications), Tylenol, or topical therapy
• co-morbidities including, congestive heart failure, hepatic or renal disease, chronic infectious diseases, non-cutaneous cancer within last five years
• comorbidities that would make lap band surgery contraindicated (severe cardiopulmonary diseases, severe esophagitis, stomach or duodenal ulcers, esophageal or gastric varices, inflammatory bowel disease, liver cirrhosis, chronic pancreatitis, alcohol or drug addiction, on chronic steroid treatment, or active infections)
• anterior-posterior (AP) radiograph of both knees with K-L grade \< 2
• pregnancy or women of childbearing potential with a positive pregnancy test during pre-surgical phases of the study as part of standard of care pre-op testing.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Center for Musculoskeletal Care

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 22, 2014
• Study Start: October 23, 2012
• Primary Completion: October 18, 2018
• Study Completion: October 18, 2018
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

US (1)