Transtibial Amputation Management Strategies
PI: Bruce Sangeorzan, M.D.
Introduction: Lower limb amputations continue to be a problem in the United States. The dramatic amputation reduction goals of the 1990’s were not realized. Of 60,000 lower limb amputations in the VHA between 1989 and 1998, transtibial amputations occurred in 29% of persons with diabetes and 24% in persons without diabetes. Patients with transtibial amputations frequently experience problems with pain, edema, contractures, and complications requiring additional surgery, limited return to function, limited satisfaction and high rehabilitation costs. Definitive evidence is lacking on the optimal post-operative transtibial management strategy.
Objectives: The primary aim is to assess standardized procedures and data management protocols in a pilot study of transtibial amputees randomized to one of three types of management strategy (soft dressing, rigid plaster dressing or rigid dressing with pneumatic airbladders) and to measure six primary outcomes: pain, time to primary healing, edema, rehabilitation success, limb complications and restoration of functional ability. Secondary aims of this pilot study are to assess instruments to measure six secondary outcomes in these transtibial amputees: cost, health care utilization, patient satisfaction, team satisfaction, quality of life and phantom pain; and to prepare the protocol for the subsequent multi-site clinical trial to determine the most effective management strategy for patients with transtibial amputations. To test the usefulness of various questionnaires and data collection tools used to measure the effectiveness of definitive transtibial amputee management strategies.
Patient Enrollment: We enrolled 19 veterans with new transtibial amputations (TTA) by October 2004. Our first study subject was enrolled on October 16, 2003 and our last subject was enrolled on February 14, 2006. The total time for subject recruitment was protracted (2.3 years).
Data analysis: Analysis to date identifies some differences between transtibial amputation management strategies. One difference that was not expected was the increased use of the off the shelf protective device (Flo-Tech Tor). The standard of post-operative care at the Seattle VA now includes the use of the Flo-Tech Tor after the removal of the plaster cast usually the second week post-op. The Flo-Tech is light weight, easily removed for examination of the suture line and the patients like the convenience of wearing something light weight.
Patient Follow-up: Of the 19 enrolled subjects, 18 completed the trial.
Adverse Reactions: Two patients have had moderate problems with their dressing treatment. One subject (TAMS 17) hit his residual limb, which resulted in swelling at the tibial tubercle but resolved without complications. Another subject (TAMS 23) fell while admitted to a SNF. When he was seen at the clinic, his wound was macerated, required a surgical revision and an above the knee amputation. Other subjects have reported minor and expected problems with their dressing treatments.
Frequency of Treatment Success or Failure by Type of Treatment.
Proposed Timetable: Final analysis is ongoing as all patient follow-up is now completed. Study tools for pain, treatment satisfaction, quality of life and healing outcomes will be discussed.
Milestones: (1) IRB approval was obtained; and (2) 19 subjects were been enrolled and 18 completed the study.