Development And Its Clinical Application Of Adjustable Lower Limb Weight-Bearing Brace For Postoperative Rehabilitation Of Femoral Intertrochanteric Fracture

Objective:To design an adjustable lower limb weight-bearing brace for patients with femoral intertrochanteric fracture managed by Proximal Femoral Nail Anti-rotation(PFNA) and investigate its clinical curative effect of postoperative early rehabilitation.Methods:A total of 74 consecutivet patients with Evans-Jensen type Ⅱ femoral intertrochanteric fracture managed by PFNA were recruited in to our study from April 2014 to April 2015. All patients was randomly divided into two groups, with 36 patients in group A and 38 in group B. The control group (A group) was treated by conventional therapy after operation, While B group were received the adjustable weight-bearing brace 1-week postoperation. All cases were evaluated for clinical, radiological and functional outcomes. The visual analogue scale (VAS) scores, weight-bearing status and Harris scale were used for clinical and functional outcomes.Results:All the patients except 6 case were followed up 9 to 18 months, average 12.6 months. Mean VAS scores was 2.85±0.85 and 1.36±0.74 respectively in group A at 3-months and 6-months follow-up. While the mean VAS scores was 2.53±0.92 and 0.94± 0.76 in group B. There is a statistical differences of VAS scores between two groups at 3-months and 6-months follow-up (P<0.05). The mean of weight-bearing status increased from (16.42±5.47)% at 1-months follow-up to (55.46±10.41)% at 1-months follow-up and (76.54± 11.62)% at 6-months follow-up in group A. While the mean weight-bearing status was (24.56±8.14)%, (67.09±11.21)% and (82.68±12.63)% in group B. Significant differences of weight-bearing status was found between two groups (all P<0.05). Patients had successful bony fusion at a mean of (16±3.7) and 14±2.5 weeks at their follow-up in A and B group respectively (P<0.01). The mean of Harris score increased from 54.5±10.5 at 1-months follow-up to 72.0±12.5 at 1-months follow-up and 81.5±19.5 at 6-months follow-up in group A. While the mean Harris score was 58.5±11.0,78.5±13.0 and 88.0±14.5 in group B. Statistical analysis revealed that there was significant difference in Harris score between A and B group at their follow-up (P<0.01). The functional outcome was assessed using Harris score system and the functions of the 9 cases and 16 cases were classified as excellent while the other 20 cases and 18 cases were marked as good in A and B group respectively (P<0.01).Conclusion:Early application of the adjustable weight-bearing brace for patients with Evans-Jensen type Ⅱ femoral intertrochanteric fracture managed by PFNA can reduce postoperative pain, accelerate the growth of callus shorten the bony healing time, reduce the incidence of complications and improve life quality. Patients can be assisted with the brace for early, regularly, suitably, securely weight-bearing. Moreover, the brace can be used as a routine postoperative adjuvant therapy tool for Ⅱ femoral intertrochanteric fracture managed by PFNA.