Recruiting

Observational Study

Sponsor:

Nova Scotia Health Authority

Code:

NCT05120492

Conditions

Knee Osteoarthritis

Morbid Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

bariatric surgery followed by total knee replacement

Study Details

Brief summary:

Does weight loss surgery in patients with morbid obesity prior to knee replacement surgery improve outcomes from knee replacement surgery

Conditions

Knee Osteoarthritis

Morbid Obesity

Study ID

NCT05120492

Start date

Apr 22, 2022

Status verified date

Aug, 2024

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

severe knee osteoarthritis body-mass index of 45 to 60

Exclusion Criteria:

previous total replacement of the same knee, a need for bilateral total knee replacement, and knee pain during the previous week that the patient rated at higher than 60 mm on a 100-mm visual-analogue scale. Also,prior bariatric or complex foregut surgery, significant cardiovascular, pulmonary, renal, liver, gastrointestinal, psychiatric disorders, pregnancy, malignancy within last 5 years, anemia, coagulopathy requiring anti-coagulation therapy.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Surgical weight loss

sleeve gastrectomy + dietary and lifestyle counseling prior to total knee replacement

no intervention: Standard of Care

dietary and lifestyle counseling prior to total knee replacement

Interventions

bariatric surgery followed by total knee replacement

The only intervention is the randomization of the priority of the 2 procedures.

Primary outcome measure

  • Pain, mobility and quality of Life [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada, B4E 0H4

Contacts

James Ellsmere, MD

902-473-1886JELLSMER@DAL.CA

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 21, 2024

Last verified

Aug, 2024

Keywords

  • Arthroplasty, Replacement, Knee
  • Bariatric Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2024-08-21.