Effects of Shrinker Use on Healing and Volume
We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers. We also expect them to experience greater reduction in residual limb volume during the early stages of postoperative care leading up to prosthetic fitting, fewer healing complications, reduced time to the prosthetic fitting, increased time to the first prosthetic socket replacement, and fewer socket replacements by the end of the "transition to stable phase".
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Shrinker Use on Healing and Volume for Transtibial Amputees|
- reduction in time to healing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Shrinker
Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.
Device: compression shrinker
Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker
Other Name: Juzo® Compression Therapy Garment
No Intervention: No Shrinker
Patients will receive no shrinker
Edema is an inevitable result of amputation surgery. Persistent edema can affect oxygen and nutrient flow into, as well as waste flow out of the residual limb. Shrinkers are a common and effective treatment for edema. However, their influence on healing and long term limb volume has not been studied. This study will pertain to human subjects affected by primary transtibial amputation. Two interventional groups of patients will use shrinkers with different levels of compression as part of their rehabilitation. A third, control group will not use shrinkers. The groups will be studied to determine the effects of shrinker use on healing and long term residual limb volume.
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Jonathan Day, BSPO||University of Oklahoma Health Sciences Center Department of Orthopedic Surgery & Rehabilitation, Division of Orthotics & Prosthetics|