Knee OsteoarthritisNCT02272218
Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis
A study testing bariatric lap band surgery in people with Knee Osteoarthritis, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- bariatric lap band surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2012to 18 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Musculoskeletal Care
New York, New York, 10016
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- bariatric lap band surgery
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric lap band surgeryProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: bariatric lap band surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in OA-related pain and disability after LAGB.
questionnaires will be distributed pre- and post-surgery.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study start23 Oct 2012
- Primary completion18 Oct 2018
- Study completion18 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272218
- Sponsor's protocol ID
- 12-03313
- Status last verified
- Feb 2020
- First submitted
- 10 Oct 2014
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02272218
- Acronym / sponsor ID
- 12-03313
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 23 Oct 2012 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAGB | Other | Procedure: bariatric lap band surgeryThere is only one arm for this study, since this study involves a single cohort receiving the same intervention, laparoscopic gastric banding (LAGB) surgery. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- anterior-posterior (AP) radiograph of at least one knee with Kellgren-Lawrence (K-L) grading scale ≥ 2 (moderate to severe osteoarthritis)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bariatric lap band surgeryThe 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 | Procedure or surgery | LAGB |
Primary outcome
reduction in OA-related pain and disability after LAGB.
Time frame: 4 years
questionnaires will be distributed pre- and post-surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bariatric lap band surgery in people with Knee Osteoarthritis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in OA-related pain and disability after LAGB. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.