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

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?)

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.