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Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

bariatric lap band surgery

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
1. clinically diagnosed with knee OA using American College of Rheumatology (ACR) criteria.
2. Patient pain visual analog scale (VAS) ≥40
3. 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)

Exclusion Criteria:

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.

Sites / Locations

Center for Musculoskeletal Care

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

LAGB

Arm Description

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

Outcomes

Primary Outcome Measures

reduction in OA-related pain and disability after LAGB.

questionnaires will be distributed pre- and post-surgery.

Secondary Outcome Measures

Full Information

NCT ID

NCT02272218

First Posted

October 10, 2014

Last Updated

February 7, 2020

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT02272218

Brief Title

Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis

Official Title

Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

October 23, 2012 (Actual)

Primary Completion Date

October 18, 2018 (Actual)

Study Completion Date

October 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LAGB

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

bariatric lap band surgery

Intervention Description

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

Primary Outcome Measure Information:

Title

reduction in OA-related pain and disability after LAGB.

Description

questionnaires will be distributed pre- and post-surgery.

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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.

Facility Information:

Facility Name

Center for Musculoskeletal Care

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

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Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis

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