To compare the long-term outcomes of fibular nailing and plate fixation for unstable ankle fractures in a cohort of patients under the age of 65 years. Patients from a previously conducted randomized control trial comparing fibular nailing and plate fixation were contacted at a minimum of 10 years post intervention at a single study centre. Short term data were collected prospectively and long-term data were collected retrospectively using an electronic patient record software. Ninety-nine patients from one trauma centre were included (48 fibular nails and 51 plate fixations). Groups were matched for gender ( The current study illustrates no difference between fibular nail fixation and plate fixation at a long-term follow up of 10 years in patients under 65 years old, although the study is currently under powered.
Limited long term data exists comparing operatively and non-operatively treated Achilles tendon ruptures. A previous randomised controlled trial comparing early outcomes showed a short term advantage for surgery, but there are no long term prospective randomised comparisons. Our aim was to determine whether surgery conferred long term benefits in terms of patient reported outcomes or re-rupture. 64 patients (80%) were followed up with postal questionnaires. Patients were asked to complete the Short Musculoskeletal Function Assessment (SMFA), Achilles Tendon Total Rupture Score (ATRS) and EQ-5D questionnaires, and to report re-ruptures. 32 patients were treated non-operatively and 32 operatively; 59 completed the SMFA and 64 the ATRS and EQ-5D assessments. There was no significant difference in SMFA score (median 1.09, IQR 4.89 in the cast group versus 2.17 and 7.07 in the operative group; p=0.347), ATRS (median 96, IQR 18 versus 93 and 15; p=0.509), EQ-5D Index (median 1.0, IQR 0.163 versus 1.0 and 0.257; p=0.327) and EQ-5D Visual Analogue Score (median score 85, IQR 15 versus 85 and 24; p=0.650). There were 2 re-ruptures in the operative group and 4 in the non-operative group (p=0.067). This is the first prospective, randomised, long term report comparing operative and non-operative management. At follow up between 13–17 years after injury, patients reported good function and health related quality of life. There was no significant difference in re-rupture rate between the treatment groups.
This prospective randomised trial aimed to assess the superiority of internal fixation of well-reduced medial malleolar fractures (displacement □2mm) compared with non-fixation, following fibular stabilisation in patients undergoing surgical management of a closed unstable ankle fracture. A total of 154 adult patients with a bi- or trimalleolar fracture were recruited from a single centre. Open injuries and vertically unstable medial malleolar fractures were excluded. Following fibular stabilisation, patients were randomised intra-operatively on a 1:1 basis to fixation or non-fixation after satisfactory fluoroscopic fracture reduction was confirmed. The primary outcome was the Olerud Molander Ankle Score (OMAS) at 12 months post-randomisation. Complications were documented over the follow-up period. The baseline group demographics and injury characteristics were comparable. There were 144 patients reviewed at the primary outcome point (94%). The median OMAS was 80 (IQR, 60-90) in the fixation group vs. 72.5 (IQR, 55-90) in the non-fixation group (p=0.165). Complication rates were comparable, although significantly more patients (n=13, 20%) in the non-fixation group developed a radiographic non-union (p<0.001). The majority (n=8/13) were asymptomatic, with one patient requiring surgical reintervention. In the non-fixation group, a superior outcome was associated with an anatomical medial malleolar fracture reduction. Internal fixation is not superior to non-fixation of well-reduced medial malleolar fractures when managing unstable ankle fractures. However, one in five patients following non-fixation developed a radiographic non-union and whilst the re-intervention rate to manage this was low, the longer-term consequences of this are unknown. The results of this trial may support selective non-fixation of anatomically reduced fractures.
This prospective, randomized, controlled trial compares patient outcome after non-operative care versus open reduction and tunneled suspension device fixation (ORTSD) for grade III or IV acromioclavicular joint disruptions. Sixty patients aged between sixteen and thirty-five years with an acute grade III or IV AC joint disruption were randomized to receive ORTSD fixation or non-operative treatment. Functional assessment was conducted at six weeks, three months, six months, and one year using the Disabilities of the Arm, Shoulder and Hands (DASH), Oxford Shoulder Scores (OSS) and Short Form (SF-12). Reduction was evaluated using radiographs. Complications were recorded, and an economic evaluation performed. There was no significant difference in DASH or OSS at one year between non-operative and ORTSD groups (DASH score, 4.67 versus 5.63; OSS, 45.72 versus 45.63). Patients undergoing surgery had inferior DASH scores at 6 weeks (p<0.01). Five patients who failed non-operative management subsequently received surgery. Overall cost of treatment was significantly greater after ORTSD fixation (£796.22 vs £3359.73 (p<0.01)). ORTSD fixation confers no functional benefit over non-operative treatment at one year. While patients managed non-operatively generally recover faster, a significant group remain dissatisfied following non-operative treatment requiring delayed surgical reconstruction.
Randomized, controlled trials (RCTs) are generally accepted as the “gold standard” for the provision of the most unbiased measures of the efficacy of interventions but are often criticized for the lack of external validity. We assessed the external validity of a RCT examining the efficacy of local infiltration analgesia (LIA) compared with continuous epidural infusion after total knee arthroplasty (TKA) During a one-year period, all patients consecutively admitted for elective, unilateral, primary TKA were identified as potential participants. All underwent eligibility screening to determine who were eligible for participation in a randomized controlled trial. We investigated the distribution of preoperative characteristics and postoperative variables among excluded patients, non-consenters, and enrolled and randomized participants.Background
Methods
The objective of this study was to compare differences in alignment following robotic arm-assisted bi-unicompartmental knee arthroplasty (Bi-UKA) and conventional total knee arthroplasty (TKA). This was a prospective, randomised controlled trial of 70 patients. 39 TKAs were implanted manually, as per standard protocol at our institution, and 31 Bi-UKA patients simultaneously received fixed-bearing medial and lateral UKAs, implanted using robotic arm-assistance. Preoperative and 3-month postoperative CT scans were analysed to determine hip knee ankle angle (HKAA), medial distal femoral angle (MDFA), and medial proximal tibial angle (MPTA). Analysis was repeated for 10 patients by a second rater to validate measurement reliability by calculating the intra-class correlation coefficient (ICC). Mean change in HKAA towards neutral was 2.7° in TKA patients and 2.3° in Bi-UKA patients (P=0.6). Mean change in MDFA was 2.5° for TKA and 1.0° for Bi-UKA (P<0.01). Mean change in MPTA was 3.7° for TKA and 0.8° for Bi-UKA (P<0.01). Mean postoperative MDFA and MPTA for TKAs were 89.8° and 89.6° respectively, indicating orientation of femoral and tibial components perpendicular to the mechanical axis. Mean postoperative MDFA and MPTA for Bi-UKAs were 91.0° and 86.9° respectively, indicating a more oblique joint line orientation. Inter-rater agreement was excellent (ICC>0.99). Early functional activities, according to the new Knee Society Scoring System, favoured Bi-UKAs (P<0.05). Robotic arm-assisted, cruciate-sparing Bi-UKA better maintains the natural anatomy of the knee in the coronal plane and may therefore preserve normal joint kinematics, compared to a mechanically aligned TKA. This has been achieved without significantly altering overall HKAA.
The long-term impact of dividing Piriformis when performing a standard posterior approach to the hip has not been assessed. A less invasive approach in which the tendon is preserved has been described (the Piriformis-sparing minimally invasive [PSMI] approach). With advances in MRI technology it is now possible to image structures in close proximity to metal without artifact. The aim of the study was to compare the MRI features (muscle grade and bulk) of the divided and repaired Piriformis tendon group (by the standard posterior approach) with the preserved tendon group (by the PSMI approach). As part of an on-going randomized controlled trial comparing the PSMI approach with the standard posterior approach for total hip replacement, a subgroup of 20 consecutive patients who fulfilled the inclusion criteria were recruited. Patients received preoperative and 3 months and 2 year postoperative MRI scans. Patients and evaluators were blinded to allocation. Outcomes assessed included grade, volume and integrity of Piriformis.Background
Methods
Medial opening-wedge high tibial osteotomy is one of the common surgical procedures in treatment of knee deformities. Many methods have been proposed to fill the medial side osseous gap. The results of using allograft as void filler compared to iliac crest autograft has not been subject to a randomized clinical trial. The purpose of this study was to examine the results of medial opening-wedge high tibial osteotomy using iliac crest allograft as compared to iliac crest autograft. Forty-six patients with genovarum deformity were enrolled based on specific inclusion and exclusion criteria and were randomly assigned into two groups. Medial opening-wedge high tibial osteotomy was done using iliac crest allograft (23 patients) or autograft (23 patients) and the osteotomy site was internally fixed using proximal tibial T-plate. All patients were followed-up to 12 months after surgery. Anatomical indices of proximal tibia, complications of treatment, and functional outcome (using WOMAC osteoarthritis index) were assessed for both groups.Background
Materials & Methods
The Versajet™ Hydrosurgery system (Smith & Nephew) offers a unique way of performing debridement using a high pressure fluid jet parallel to the surface to draw devitalized soft tissues into a cutting chamber for excision and evacuation. The aim of this study was to assess the outcome of the Versajet hydrosurgery system in the treatment of Gustilo and Anderson grade III A and III B open tibial fractures using a pilot scale prospective randomized controlled trial against conventional surgery. The primary variable was the total number of debridements until wound closure. A total of 40 patients were recruited: 16 patients Versajet Plus™ (Smith & Nephew) hydrosurgery vs patients 24 standard surgical debridement. Baseline characteristics were well balanced with respect to the age, mechanism of injury, contamination, wound area, depth, and displacement of the bone. There was some imbalance between treatment groups where more (68.8%) Versajet patients had III A classification; vs. (37.5%) standard surgical debridement patients. The number of debridement procedures before wound closure was for Versajet: 1 debridement procedure for 11 patients (69%), 2 for 3 patients (19%) and 3 for 2 patients (12.5%). For standard surgical patients: 1 debridement procedure for 1 patient (4.3%), 2 for 19 patients (83%) and 3 for 3 patients (13%). There was significant evidence (p<0.001) that Versajet patients required fewer debridement procedures than standard surgical debridement prior to wound closure (ratio Standard: Versajet=1.747). There was no evidence that the number of debridement procedures to achieve wound closure differed between the Gustilo and Anderson grade IIIA and grade IIIB classifications (p=0.692). The median time to wound closure was 3 days (95% CI 3 days, 5 days) for Versajet and 5 days (95% CI 4 days, 8 days) for standard surgically debrided wounds, but the difference was not statistically significant (p=0.275). There was no evidence (p=0.397) of a difference in the total number of surgical sessions (debridement or debridement with closure) required to close the wound (ratio Standard: Versajet=1.040; 95% CI (0.950, 1.137). There were no instances of post operative infection. This pilot study has shown that on average only a single Versajet Plus hydrosurgery debridement is needed before IIIA or IIIB wounds are ready for closure and there is a trend (not significant) towards the possibility of earlier closure following the use of Versajet compared with standard surgery.