BACKGROUND: Distal radius fractures are often surgically treated if insufficient reduction has been achieved or after conservative treatment has failed. Treatment using metal implants often demands a secondary operation to remove the implant. A bio-resorbable implant (in this study the Reunite osteosynthesis plate by Biomet Inc) should obviate the need for a secondary operation with equal functional results. MATERIALS AND METHODS:Thirty-two patients with a distal radius fracture were assigned to treatment with either a bio-resorbable implant (N = 19) or a metal implant (N = 13). Both groups received the same postoperative care and were followed for 52 weeks in the outpatient clinic. The hypothesis of this study was a decrease in re-operation rate in the experimental group with equal functional results. RESULTS: Five out of 19 patients treated with the Reunite plate were re-operated and four out of 13 treated with metal implants needed a secondary operation. In both implants, equal functional results in Range of Motion and DASH scores were found. CONCLUSION: There were no significant differences between the experimental and control group with respect to re-operations, DASH scores and Range of Motion. Because of the higher initial costs and equal results, the use of bio-resorbable implants must be considered carefully.
RCT Entities:
BACKGROUND: Distal radius fractures are often surgically treated if insufficient reduction has been achieved or after conservative treatment has failed. Treatment using metal implants often demands a secondary operation to remove the implant. A bio-resorbable implant (in this study the Reunite osteosynthesis plate by Biomet Inc) should obviate the need for a secondary operation with equal functional results. MATERIALS AND METHODS: Thirty-two patients with a distal radius fracture were assigned to treatment with either a bio-resorbable implant (N = 19) or a metal implant (N = 13). Both groups received the same postoperative care and were followed for 52 weeks in the outpatient clinic. The hypothesis of this study was a decrease in re-operation rate in the experimental group with equal functional results. RESULTS: Five out of 19 patients treated with the Reunite plate were re-operated and four out of 13 treated with metal implants needed a secondary operation. In both implants, equal functional results in Range of Motion and DASH scores were found. CONCLUSION: There were no significant differences between the experimental and control group with respect to re-operations, DASH scores and Range of Motion. Because of the higher initial costs and equal results, the use of bio-resorbable implants must be considered carefully.