Objective: To objectively evaluate the clinical efficacy, safety and technical operating standard of percutem clamp fixation (PCCF), an operation designed by imitating bone setting method of TCM, in treating unstable tibiofibular fracture (UTF).
Methods: A prospective controlled multicentre clinical study was carried out on 200 patients with UTF, they were assigned to the treated group (99 cases) treated with PCCF and the control group (101 cases) treated with unilateral multifunctional external fixator (UMFEF).
Results: PCCF showed better effects than UMFEF in reducing the time of fixing operation and healing time; and the immediate effect after removing the fixating apparatus and long-term efficacy as well as safety in the treated group were also superior to those in the control group (P < 0.01).
Conclusion: It is convenient, safe and effective to treat UTF by fixation with percutem clamp.