ObesitySWIFTNCT02598531

Surgical Weight-Loss to Improve Functional Status Trajectories Following Total Knee Arthroplasty (SWIFT Trial)

An observational study of Obesity and Osteoarthritis, run by Geisinger Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of the SWIFT Trial is to answer two research questions. 1. Does bariatric surgery before total knee arthroplasty (TKA) improve both perioperative and long-term outcomes of TKA in extreme obesity? 2. Does bariatric surgery before TKA delay or possibly negate the need for arthroplasty? Read more about this study

Who is it for?: Ages 22 to 75 years
Conditions the study is for: Obesity, Osteoarthritis
How many people: 289 participants
Where: 1 siteUnited States
Study dates: Jan 2016to 31 Oct 2024
Phase: Observational
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 22 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Study population is defined using the inclusion and exclusion criteria below. Demographic information (with the exclusion of age) is not used to determine the study population.

Who may be able to join

Age 22-75 years.
Subject is diagnosed with Non-inflammatory Degenerative Joint Disease(NIDJD).
Subject is diagnosed with Morbid Obesity (Body Mass Index ≥ 40 kg/m2 or >35 kg/m2 with qualifying comorbid conditions such as obstructive sleep apnea or diabetes).
Subject is a suitable candidate for cemented primary TKA with either resurfaced or non-resurfaced patellae.
Subject is currently not bedridden.
Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
Subject has given voluntary, written informed consent to participate in this clinical investigation.
Subject is comfortable with speaking, reading, and understanding questions and providing responses in an available translated language.

Who cannot join

Subject has undergone THA or contralateral knee within the past 6 months.
Subject has had a contralateral amputation.
Subject requires simultaneous bilateral TKA.
Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
Subject is currently experiencing radicular pain from the spine.
Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.

Show all 14Show fewer

Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
Subject has had previous bariatric surgery.
Subject is medically or psychologically not suitable to undergo surgery.
Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
Subject has a medical condition with less than 2 years of life expectancy.
Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.
Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language.

Trial locations and contacts

1 site in 1 country.

United States1 site

Geisinger Health System
Danville, Pennsylvania, 17822

Other trials in United States

About this study

The purpose of the SWIFT Trial is to answer two research questions.

Does bariatric surgery before total knee arthroplasty (TKA) improve both perioperative and long-term outcomes of TKA in extreme obesity?
Does bariatric surgery before TKA delay or possibly negate the need for arthroplasty?

Read the detailed description

Obese patients pursing a TKA procedure are typically encouraged to lose weight prior to the procedure as part of the patient's treatment plan. If the patient chooses to receive treatment for his or her obesity, the Orthopedic provider may refer the patient to a weight management provider. If a patient is eligible for TKA and meets the inclusion and exclusion criteria (containing BMI and corresponding comorbidity measures), he/she is eligible to participate in the study.

In this study there will be two arms, a Test Arm in which patients undergo bariatric surgery prior to TKA and a Control Arm in which patients undergo TKA only. Patients will choose which arm they enter, based on whether or not they want to undergo surgical weight loss intervention prior to TKA.

Test Arm: Participants will either undergo Laparoscopic Sleeve Gastrectomy or Laparoscopic Gastric Bypass surgery. Approximately 9-13 months post bariatric surgery, each test arm participant will be evaluated to determine if he/she is still a candidate or if the need for knee replacement no longer exists (or is delayed). If the participant is still a candidate, he/she will undergo TKA. Participants will complete nine (9) research visits over the course of 3.5 - 4 years, in addition to the standard of care visits required for bariatric surgery and TKA. Research visits will include study activities such as vital sign measurements, orthopedic outcome assessments, physical function assessments (i.e. stair climb, 400 meter walk, etc.), questionnaire completion, and synovial fluid collection if the patient has a TKA procedure performed.

Control Arm: Participants in the control arm undergo a total knee replacement without surgical weight loss intervention and will complete six (6) research visits over the course of 2.5-3 years, in addition to the standard of care visits required for TKA. Research visits will include study activities such as vital sign measurements, orthopedic outcome assessments, physical function assessments (i.e. stair climb, 400 meter walk, etc.), questionnaire completion, and synovial fluid collection at the time of TKA.

The study hypothesis is that weight loss induced by bariatric surgery prior to TKA will improve TKA outcomes in patients with extreme obesity. The study hypothesis will be met if one of the following outcomes is achieved:

In >=20% of bariatric surgery patients, the need for TKA was negated or delayed for at least two years.
A statistically significant superiority is found among those patients undergoing bariatric surgery + TKA versus those undergoing TKA only in at least two of the following domains at two years post TKA:
Mobility (400 meter walk test)
Osteoarthritis outcome (WOMAC total score)
Knee orthopedic outcome (Knee Society score)
Quality of life (PROMIS-29 Quality of Life Questionnaire)
Osteoarthritic Pain (KOOS Pain)
Patient Satisfaction (If you had to live the rest of your life with the symptoms you have now, how would you feel?)

Conditions: Obesity, Osteoarthritis
Medical subject headings: Obesity, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02598531
Study group	Role	What they receive
Test Arm		Test Arm participants will be enrolled in the standard of care bariatric surgery program and will undergo surgical weight loss through Laparoscopic Sleeve Gastrectomy or Laparoscopic Gastric Bypass. Approximately 9-13 months post surgery, each participant will be evaluated to determine if he/she is still eligible for a total knee replacement or if their need has been removed. If still eligible, participants will be enrolled in the standard of care TKA program and will undergo a TKA procedure. Participants will complete nine (9) research visits over 3.5-4 years.
Control Arm		Control Arm participants will be enrolled in the standard of care TKA program and complete six (6) research visits over 2.5-3 years. This group of participants will undergo a TKA procedure without any surgical weight loss intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of bariatric surgery patients who delay or no longer need TKA.
Participants in the Test Arm will undergo bariatric surgery prior to TKA. Determine if >=20% of Test Arm participants no longer need or delay the need for TKA.
Measured: 1 year post bariatric surgery

Secondary outcomes (6)

Mobility assessment using the 400 Meter Walk test
Participants will be asked to complete 10 laps around cones that are 20 meters apart. During the test, participants will be asked to rate how hard they are walking and their level of knee pain. Heart rate and blood pressure will also be monitored. Mobility will be documented and analyzed to determine if there are changes throughout the course of the study.
Measured: 2 years post TKA surgery
Pain, disability and joint stiffness will be assessed using the Osteoarthritis Outcomes Questionnaire (WOMAC total score)
The questionnaire is designed to assess pain, disability and joint stiffness in the osteoarthritis patient. Questionnaire answers will be documented and analyzed to determine if there are changes in pain, disability, and/or stiffness throughout the course of the study.
Measured: 2 years post TKA surgery
Pain, function, range of motion and joint stability will be assessed using the American Knee Society Score.
The American Knee Society Score is an assessment and questionnaire that provides a rating of the pain, function, range of motion, and knee joint stability. It is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs. Pain, function, range of motion, and joint stability will be documented and analyzed to determine if there are changes throughout the course of the study.
Measured: 2 years post TKA surgery
Quality of life will be assessed using the PROMIS-29 Quality of Life Questionnaire.
Participants will be asked to complete a validated questionnaire known as PROMIS-29 to determine their quality of life. Answers to this questionnaire will be documented and analyzed to determine if there are changes in quality of life throughout the course of this study.
Measured: 2 years post TKA surgery
Knee pain will be assessed using the Osteoarthritic Pain Questionnaire (KOOS)
The KOOS or Knee injury and Osteoarthritis Outcome Score are patient completed questionnaires which assess the patient's opinion regarding their knee and its associated osteoarthritis. Answers to this questionnaire will be documented and analyzed to determine if there are changes in knee pain throughout the course of this study.
Measured: 2 years post TKA surgery
Change in Patient Satisfaction
Participants will be asked to answer the following question: If you had to live the rest of your life with the symptoms you have now, how would you feel? Answers to this question will be documented and analyzed to determine if there are changes in patient satisfaction throughout the course of this study.
Measured: 2 years post TKA surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201631 Oct 2024

First posted6 Nov 2015 (estimated)
Study startJan 2016
Primary completion31 Oct 2024
Study completion31 Oct 2024

Why it stopped: Recruitment Failure

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
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: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 289 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02598531
Sponsor's protocol ID: 2015-0244
Acronym: SWIFT
Status last verified: Jan 2025
First submitted: 23 Oct 2015
Last updated: 22 Jan 2025
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
PubMed 15479938
Benotti P, Wood GC, Still C, Petrick A, Strodel W. Obesity disease burden and surgical risk. Surg Obes Relat Dis. 2006 Nov-Dec;2(6):600-6. doi: 10.1016/j.soard.2006.08.004. Epub 2006 Sep 22.
PubMed 16996319
Friedman RJ, Hess S, Berkowitz SD, Homering M. Complication rates after hip or knee arthroplasty in morbidly obese patients. Clin Orthop Relat Res. 2013 Oct;471(10):3358-66. doi: 10.1007/s11999-013-3049-9. Epub 2013 May 14.
PubMed 23670675
Malinzak RA, Ritter MA, Berend ME, Meding JB, Olberding EM, Davis KE. Morbidly obese, diabetic, younger, and unilateral joint arthroplasty patients have elevated total joint arthroplasty infection rates. J Arthroplasty. 2009 Sep;24(6 Suppl):84-8. doi: 10.1016/j.arth.2009.05.016. Epub 2009 Jul 15.
PubMed 19604665
Namba RS, Paxton L, Fithian DC, Stone ML. Obesity and perioperative morbidity in total hip and total knee arthroplasty patients. J Arthroplasty. 2005 Oct;20(7 Suppl 3):46-50. doi: 10.1016/j.arth.2005.04.023.
PubMed 16214002
Kerkhoffs GM, Servien E, Dunn W, Dahm D, Bramer JA, Haverkamp D. The influence of obesity on the complication rate and outcome of total knee arthroplasty: a meta-analysis and systematic literature review. J Bone Joint Surg Am. 2012 Oct 17;94(20):1839-44. doi: 10.2106/JBJS.K.00820.
PubMed 23079875
Lozano LM, Nunez M, Segur JM, Macule F, Sastre S, Nunez E, Suso S. Relationship between knee anthropometry and surgical time in total knee arthroplasty in severely and morbidly obese patients: a new prognostic index of surgical difficulty. Obes Surg. 2008 Sep;18(9):1149-53. doi: 10.1007/s11695-008-9481-3. Epub 2008 May 28.
PubMed 18506553
Severson EP, Singh JA, Browne JA, Trousdale RT, Sarr MG, Lewallen DG. Total knee arthroplasty in morbidly obese patients treated with bariatric surgery: a comparative study. J Arthroplasty. 2012 Oct;27(9):1696-700. doi: 10.1016/j.arth.2012.03.005. Epub 2012 May 2.
PubMed 22554730
Kulkarni A, Jameson SS, James P, Woodcock S, Muller S, Reed MR. Does bariatric surgery prior to lower limb joint replacement reduce complications? Surgeon. 2011 Feb;9(1):18-21. doi: 10.1016/j.surge.2010.08.004. Epub 2010 Sep 27.
PubMed 21195326
Parvizi J, Trousdale RT, Sarr MG. Total joint arthroplasty in patients surgically treated for morbid obesity. J Arthroplasty. 2000 Dec;15(8):1003-8. doi: 10.1054/arth.2000.9054.
PubMed 11112195
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716
King WC, Engel SG, Elder KA, Chapman WH, Eid GM, Wolfe BM, Belle SH. Walking capacity of bariatric surgery candidates. Surg Obes Relat Dis. 2012 Jan-Feb;8(1):48-59. doi: 10.1016/j.soard.2011.07.003. Epub 2011 Jul 23.
PubMed 21937285
Messier SP, Callahan LF, Golightly YM, Keefe FJ. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis. Osteoarthritis Cartilage. 2015 May;23(5):787-97. doi: 10.1016/j.joca.2015.03.008.
PubMed 25952349
Rikli RE, Jones CJ. Development and validation of criterion-referenced clinically relevant fitness standards for maintaining physical independence in later years. Gerontologist. 2013 Apr;53(2):255-67. doi: 10.1093/geront/gns071. Epub 2012 May 20.
PubMed 22613940
Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
PubMed 14613558

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Surgical Weight-Loss to Improve Functional Status Trajectories Following Total Knee Arthroplasty (SWIFT Trial)
ClinicalTrials.gov ID: NCT02598531
Acronym / sponsor ID: SWIFT / 2015-0244
Conditions: Obesity, Osteoarthritis
Study type: Observational
Recruitment status: TerminatedReason stopped: Recruitment Failure
Enrolment: 289 participants (actual)
Lead sponsor: Geisinger ClinicUniversity, hospital or other
Collaborators: NYU Langone Health, University of Virginia, State University of New York at Buffalo, University of Rochester, Hospital for Special Surgery, New York
Study start: Jan 2016
Primary completion: 31 Oct 2024 (actual)
Study completion: 31 Oct 2024 (actual)
First posted: 6 Nov 2015 (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 purpose of the SWIFT Trial is to answer two research questions.

Does bariatric surgery before total knee arthroplasty (TKA) improve both perioperative and long-term outcomes of TKA in extreme obesity?
Does bariatric surgery before TKA delay or possibly negate the need for arthroplasty?

Detailed description

In >=20% of bariatric surgery patients, the need for TKA was negated or delayed for at least two years.
A statistically significant superiority is found among those patients undergoing bariatric surgery + TKA versus those undergoing TKA only in at least two of the following domains at two years post TKA:
Mobility (400 meter walk test)
Osteoarthritis outcome (WOMAC total score)
Knee orthopedic outcome (Knee Society score)
Quality of life (PROMIS-29 Quality of Life Questionnaire)
Osteoarthritic Pain (KOOS Pain)
Patient Satisfaction (If you had to live the rest of your life with the symptoms you have now, how would you feel?)

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Test Arm	–	–Test Arm participants will be enrolled in the standard of care bariatric surgery program and will undergo surgical weight loss through Laparoscopic Sleeve Gastrectomy or Laparoscopic Gastric Bypass. Approximately 9-13 months post surgery, each participant will be evaluated to determine if he/she is still eligible for a total knee replacement or if their need has been removed. If still eligible, participants will be enrolled in the standard of care TKA program and will undergo a TKA procedure. Participants will complete nine (9) research visits over 3.5-4 years.
Control Arm	–	–Control Arm participants will be enrolled in the standard of care TKA program and complete six (6) research visits over 2.5-3 years. This group of participants will undergo a TKA procedure without any surgical weight loss intervention.

Who may qualify

Ages: 22 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Study population is defined using the inclusion and exclusion criteria below. Demographic information (with the exclusion of age) is not used to determine the study population.

Key inclusion criteria (8 listed)

Age 22-75 years.
Subject is diagnosed with Non-inflammatory Degenerative Joint Disease(NIDJD).
Subject is diagnosed with Morbid Obesity (Body Mass Index ≥ 40 kg/m2 or >35 kg/m2 with qualifying comorbid conditions such as obstructive sleep apnea or diabetes).
Subject is a suitable candidate for cemented primary TKA with either resurfaced or non-resurfaced patellae.
Subject is currently not bedridden.

Key exclusion criteria (14 listed)

Subject has undergone THA or contralateral knee within the past 6 months.
Subject has had a contralateral amputation.
Subject requires simultaneous bilateral TKA.
Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
Subject is currently experiencing radicular pain from the spine.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of bariatric surgery patients who delay or no longer need TKA.
Time frame: 1 year post bariatric surgery
Participants in the Test Arm will undergo bariatric surgery prior to TKA. Determine if >=20% of Test Arm participants no longer need or delay the need for TKA.

6 secondary outcomes

Mobility assessment using the 400 Meter Walk test
Time frame: 2 years post TKA surgery
Pain, disability and joint stiffness will be assessed using the Osteoarthritis Outcomes Questionnaire (WOMAC total score)
Time frame: 2 years post TKA surgery
Pain, function, range of motion and joint stability will be assessed using the American Knee Society Score.
Time frame: 2 years post TKA surgery
Quality of life will be assessed using the PROMIS-29 Quality of Life Questionnaire.
Time frame: 2 years post TKA surgery
Knee pain will be assessed using the Osteoarthritic Pain Questionnaire (KOOS)
Time frame: 2 years post TKA surgery
Change in Patient Satisfaction
Time frame: 2 years post TKA surgery

Results and safety

The study was stopped early (reason given: Recruitment Failure). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
Background: PubMed 15479938Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
Background: PubMed 16996319Benotti P, Wood GC, Still C, Petrick A, Strodel W. Obesity disease burden and surgical risk. Surg Obes Relat Dis. 2006 Nov-Dec;2(6):600-6. doi: 10.1016/j.soard.2006.08.004. Epub 2006 Sep 22.
Background: PubMed 23670675Friedman RJ, Hess S, Berkowitz SD, Homering M. Complication rates after hip or knee arthroplasty in morbidly obese patients. Clin Orthop Relat Res. 2013 Oct;471(10):3358-66. doi: 10.1007/s11999-013-3049-9. Epub 2013 May 14.
Background: PubMed 19604665Malinzak RA, Ritter MA, Berend ME, Meding JB, Olberding EM, Davis KE. Morbidly obese, diabetic, younger, and unilateral joint arthroplasty patients have elevated total joint arthroplasty infection rates. J Arthroplasty. 2009 Sep;24(6 Suppl):84-8. doi: 10.1016/j.arth.2009.05.016. Epub 2009 Jul 15.
Background: PubMed 16214002Namba RS, Paxton L, Fithian DC, Stone ML. Obesity and perioperative morbidity in total hip and total knee arthroplasty patients. J Arthroplasty. 2005 Oct;20(7 Suppl 3):46-50. doi: 10.1016/j.arth.2005.04.023.
Background: PubMed 23079875Kerkhoffs GM, Servien E, Dunn W, Dahm D, Bramer JA, Haverkamp D. The influence of obesity on the complication rate and outcome of total knee arthroplasty: a meta-analysis and systematic literature review. J Bone Joint Surg Am. 2012 Oct 17;94(20):1839-44. doi: 10.2106/JBJS.K.00820.
Background: PubMed 18506553Lozano LM, Nunez M, Segur JM, Macule F, Sastre S, Nunez E, Suso S. Relationship between knee anthropometry and surgical time in total knee arthroplasty in severely and morbidly obese patients: a new prognostic index of surgical difficulty. Obes Surg. 2008 Sep;18(9):1149-53. doi: 10.1007/s11695-008-9481-3. Epub 2008 May 28.
Background: PubMed 22554730Severson EP, Singh JA, Browne JA, Trousdale RT, Sarr MG, Lewallen DG. Total knee arthroplasty in morbidly obese patients treated with bariatric surgery: a comparative study. J Arthroplasty. 2012 Oct;27(9):1696-700. doi: 10.1016/j.arth.2012.03.005. Epub 2012 May 2.
Background: PubMed 21195326Kulkarni A, Jameson SS, James P, Woodcock S, Muller S, Reed MR. Does bariatric surgery prior to lower limb joint replacement reduce complications? Surgeon. 2011 Feb;9(1):18-21. doi: 10.1016/j.surge.2010.08.004. Epub 2010 Sep 27.
Background: PubMed 11112195Parvizi J, Trousdale RT, Sarr MG. Total joint arthroplasty in patients surgically treated for morbid obesity. J Arthroplasty. 2000 Dec;15(8):1003-8. doi: 10.1054/arth.2000.9054.
Background: PubMed 3558716Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Background: PubMed 21937285King WC, Engel SG, Elder KA, Chapman WH, Eid GM, Wolfe BM, Belle SH. Walking capacity of bariatric surgery candidates. Surg Obes Relat Dis. 2012 Jan-Feb;8(1):48-59. doi: 10.1016/j.soard.2011.07.003. Epub 2011 Jul 23.
Individual participant dataSharing planned: No

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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.

Christopher D Still, DO, FACN, FACP principal investigator

Geisinger Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Osteoarthritis, run by Geisinger Clinic 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 14 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: stopped early, as of the sponsor's last update on 22 Jan 2025. 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 was stopped early (reason given: Recruitment Failure). Results are not available in the source record.

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?

Number of bariatric surgery patients who delay or no longer need TKA. (time frame: 1 year post bariatric surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02598531, which also lists 18 linked publications.

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 22 Jan 2025.