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

NCT02598531 | Terminated DMC

• 1 other identifier: 2015-0244
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Obesity; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mobility assessment using the 400 Meter Walk test

  2 years post TKA surgery

• Pain, disability and joint stiffness will be assessed using the Osteoarthritis Outcomes Questionnaire (WOMAC total score)

  2 years post TKA surgery

• Pain, function, range of motion and joint stability will be assessed using the American Knee Society Score.

  2 years post TKA surgery

• Quality of life will be assessed using the PROMIS-29 Quality of Life Questionnaire.

  2 years post TKA surgery

• Knee pain will be assessed using the Osteoarthritic Pain Questionnaire (KOOS)

  2 years post TKA surgery

Study Arms (2)

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.

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Geisinger Clinic: lead
• NYU Langone Health: collaborator
• University of Virginia: collaborator
• State University of New York at Buffalo: collaborator
• University of Rochester: collaborator
• Hospital for Special Surgery, New York: collaborator

Study Sites (1)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Related Publications (18)

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• 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.

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Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples Synovial Fluid

MeSH Terms

Conditions

Obesity; Osteoarthritis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Christopher D Still, DO, FACN, FACP

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: November 6, 2015
• Study Start: January 1, 2016
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)