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

  • STATUS
    Recruiting
  • End date
    Nov 15, 2025
  • participants needed
    300
  • sponsor
    Geisinger Clinic
Updated on 15 March 2022
diabetes
body mass index
total knee replacement
arthropathy
bariatric surgery
morbid obesity
joint reconstruction

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?)

Details
Condition Obesity, Osteoarthritis
Clinical Study IdentifierNCT02598531
SponsorGeisinger Clinic
Last Modified on15 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note