A randomized controlled trial comparing functional outcome and cost efficiency of a total surface-bearing socket versus a conventional patellar tendon-bearing socket in transtibial amputees.

OBJECTIVE: To compare functional outcome and cost efficiency of a total surface-bearing (TSB) socket with a conventional patellar tendon-bearing (PTB) socket in transtibial amputees.

DESIGN: Prospective randomized controlled trial.

SETTING: Outpatient rehabilitation clinic of a general hospital, rehabilitation research department of a university hospital, and certified prosthetics and orthotics workplace.

PARTICIPANTS: Twenty-six adult unilateral transtibial amputees walking with a prosthesis for at least 1 year.

INTERVENTION: Subjects were randomly assigned to 2 groups: one receiving an ICEX TSB socket, the other a conventional PTB socket.

MAIN OUTCOME MEASURES: Prosthetic Evaluation Questionnaire (PEQ) score, mobility-related activities of daily life, and gait characteristics at baseline and 3 months after initial socket fitting, as well as cost of materials, manufacturing time, and number of visits and interventions.

RESULTS: No significant differences were found between both groups in terms of changes in socket function (PEQ scores, mobility-related activities, gait characteristics). In the TSB sockets, cost of materials was significantly larger, but the manufacturing time was significantly shorter and the number of visits was significantly less than in the PTB sockets.

CONCLUSIONS: Both sockets performed equally well in terms of patient satisfaction, mobility-related activities performed during daily life, and gait performance. Material costs were higher in the TSB group, whereas the manufacturing time in the TSB group was lower.