None listed
Conditions
Brief summary
The Arthroplasty and Bariatric Surgery (ABS) study intends to examine the clinical outcomes and cost effectiveness of preceding total knee replacement (TJR) with laparoscopic adjustable gastric banding (LAGB) in a randomised controlled trial (RCT). This will be a 4 year multi-institutional randomized controlled trial in severely obese patients with end stage osteoarthritis. The study will recruit 120 severely obese people with osteoarthritis who are on the waiting list for TKR and randomly allocate them to receive the current standard of care for TKR or a combination of LAGB followed by TKR. We plan to measure weight loss, pain and function, quality of life and complications, as well as the cost effectiveness of a strategy that combines LAGB +TKR, compared to TKR alone. Participants will all be followed for one year at which time the benefits in terms of, weight loss, clinical and health improvements, adverse events and costs would be measured.
Interventions
The intervention group will undergo Laparoscopic adjustable gastric banding (LAGB) followed by total knee arthroplasty (TKA) 12 months later or after 20% loss of baseline body weight if this occurs earlier.
LAGB is a single procedure that involves placing a silicone band around the top of the stomach. The band has a balloon on its inner surface. The balloon is connected by tubing to an access port placed under the skin. Saline can be injected into the port to make the band tighter or removed to
The intervention group will undergo Laparoscopic adjustable gastric banding (LAGB) followed by total knee arthroplasty (TKA) 12 months later or after 20% loss of baseline body weight if this occurs earlier. LAGB is a single procedure that involves placing a silicone band around the top of the stomach. The band has a balloon on its inner surface. The balloon is connected by tubing to an access port placed under the skin. Saline can be injected into the port to make the band tighter or removed to make it less tight. Doing this assists with control of appetite. If the band is adjusted optimally, there should be very little hunger, there is loss of interest in food and a tendency to eat less amounts, less often. The procedure is performed laparoscopically, sometimes known as “keyhole” surgery. It is performed under a general anaesthetic and takes about 30 minutes. TKA is also a single surgical procedure whereby the diseased knee joint is replaced with artificial one. The knee is a hinge joint which provides motion at the point where the thigh meets the lower leg. During a total knee replacement, the end of the thigh (femur) bone is removed and replaced with a metal shell. The end of the lower leg bone (tibia) is also removed and replaced with a channelled plastic piece with a metal stem. Depending on the condition of the kneecap portion of the knee joint, a plastic "button" may also be added under the kneecap surface. The procedure is performed under either a general or spinal anaesthetic and takes about 1 hour
Sponsors
Professor Peter Choong
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Age less than 65 years at time of LAGB; (ii) BMI equal to or greater than 35 kg/m2; (iii) End-stage osteoarthritis, on the surgical waiting list for primary TKA at the study institution; (iv) Willing and able to cooperate in a long-term weight management programme.
Exclusion criteria
(i) Revision surgery or surgery for neoplastic disease; (ii) Inability to provide informed consent; (iii) A medical condition which in the opinion of the investigators makes the patient unsuitable for participation in the trial (iv) Previous oesophagogastric surgery such as fundoplication; (v) Lack of acceptance of the randomisation process.
Outcome results
None listed