Quality benchmark for trans-tibial prostheses in low-income countries.

Based on four series of patients (N=141) participating in clinical field testing of prosthetic feet and all provided with trans-tibial prostheses in accordance with the polypropylene component and assembly system developed by the International Committee of the Red Cross (ICRC) a series of quality benchmarks was developed and tested against historical data. The patient compliance demands were set for walking >1 km at 90 +/- 10%, non-users at 5 +/- 5%, discomfort at 10 +/- 10%, pain at 10 +/- 10%, and patient satisfaction at 90 +/- 10%. The technical performance demands were set for good socket fit at 60 +/- 10%, misalignment at 15 +/- 10%, insufficient craftsmanship at 10 +/- 10%, and requirements for socket change at 10 +/- 10%.