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

Obesity Clinical Trial

— SWIFT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02598531
• Other study ID #: 2015-0244
• Status: Recruiting
• Start date: January 2016
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2023
• Source: Geisinger Clinic
• Contact: Chris J Seiler, MBA
• Phone: 570-214-2732
• Email: cjseiler[@]geisinger.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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?

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?)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Obesity
• Osteoarthritis
• Weight Loss

Locations

Country	Name	City	State
United States	Geisinger Health System	Danville	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Geisinger Clinic	NYU Langone Health, State University of New York at Buffalo, University of Rochester, University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View Citation

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. Erratum In: JAMA. 2005 Apr 13;293(14):1728. — View Citation

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. — View Citation

Craig BM, Reeve BB, Brown PM, Cella D, Hays RD, Lipscomb J, Simon Pickard A, Revicki DA. US valuation of health outcomes measured using the PROMIS-29. Value Health. 2014 Dec;17(8):846-53. doi: 10.1016/j.jval.2014.09.005. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Working Group on Health Outcomes for Older Persons with Multiple Chronic Conditions. Universal health outcome measures for older persons with multiple chronic conditions. J Am Geriatr Soc. 2012 Dec;60(12):2333-41. doi: 10.1111/j.1532-5415.2012.04240.x. Epub 2012 Nov 29. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year post bariatric surgery
Secondary	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.	2 years post TKA surgery
Secondary	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.	2 years post TKA surgery
Secondary	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.	2 years post TKA surgery
Secondary	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.	2 years post TKA surgery
Secondary	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.	2 years post TKA surgery
Secondary	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.	2 years post TKA surgery