The effect of tourniquet use on postoperative opioid consumption after ankle fracture surgery - a retrospective cohort study.

OBJECTIVES: A pneumatic tourniquet is often used during ankle fracture surgery to reduce bleeding and enhance the visibility of the surgical field. Tourniquet use causes both mechanical and ischemic pain. The main purpose of this study was to evaluate the effect of tourniquet time on postoperative opioid consumption after ankle fracture surgery. METHODS: We retrospectively reviewed the files of 586 adult patients with surgically treated ankle fractures during the years 2014-2016. We evaluated post hoc the effect of tourniquet time on postoperative opioid consumption during the first 24 h after surgery. The patients were divided into quartiles by the tourniquet time (4-43 min; 44-58 min; 59-82 min; and ≥83 min). Multivariable linear regression analysis was used to evaluate the results. RESULTS: Tourniquets were used in 486 patients. The use of a tourniquet was associated with an increase in the total postoperative opioid consumption by 5.1 mg (95 % CI 1.6-8.5; p=0.004) during the first 24 postoperative hours. The tourniquet time over 83 min was associated with an increase in the mean postoperative oxycodone consumption by 5.4 mg (95 % CI 1.2 to 9.7; p=0.012) compared to patients with tourniquet time of 4-43 min. CONCLUSIONS: The use of a tourniquet and prolonged tourniquet time were associated with higher postoperative opioid consumption during the 24 h postoperative follow-up after surgical ankle fracture fixation. The need for ethical approval and informed consent was waived by the Institutional Review Board of Northern Ostrobothnia Health District because of the retrospective nature of the study.

Syndesmosis fixation in supination-external rotation ankle fractures. Long-Term results of a prospective randomised study.

BACKROUND: The clinical relevance and treatment of syndesmosis injury in supination-external rotation (SER) ankle fractures are controversial. METHODS: After malleolar fixation 24 SER 4 ankle fracture patients with unstable syndesmosis in external rotation stress test were randomised to syndesmosis transfixation with a screw (13 patients) or no fixation (11 patients). Mean follow-up time was 9.7 years (range, 8.9-11.0). The primary outcome measure was the Olerud-Molander Ankle Outcome Score (OMAS). Secondary outcome measures included ankle mortise congruity and degenerative osteoarthritis, 100-mm visual analogue scale for function and pain, RAND 36-Item Health Survey, and range of motion. RESULTS: Mean OMAS in the syndesmosis transfixation group was 87.3 (SD 15.5) and in the no-syndesmosis-fixation group 89.0 (SD 16.0) (difference between means 1.8, 95% CI -10.4-14.0, P = 0.76). There were no differences between the two groups in secondary outcome measures. CONCLUSION: With the numbers available, SER 4 ankle fractures with unstable syndesmosis can be treated with malleolar fixation only, with good to excellent long-term functional outcome.

Suture button versus syndesmosis screw fixation in pronation-external rotation ankle fractures: A minimum 6-year follow-up of a randomised controlled trial.

OBJECTIVE: Randomised controlled trials (RCT) with short-term follow-ups have shown that, in treatment of syndesmosis injuries, a suture button device (SB) resulted in better radiographic and functional outcome compared to syndesmosis screw fixation (SS). However, only one RCT has reported long-term results; thus, the syndesmosis malreduction rates for both implants might increase during longer follow-up. The primary objective of this RCT was to evaluate the maintenance of syndesmosis reduction with the SS compared to the SB fixation in patients during a minimum follow-up of 6-years. The secondary objectives were to assess the post-traumatic osteoarthritis (OA) grade and the functional outcome. PATIENTS AND METHODS: At Oulu University Hospital, between January 2010 and December 2011, we enrolled 43 patients with Lauge-Hansen pronation-external rotation type 4/Weber C, ankle fractures with unstable syndesmosis. Patients were randomised to treatment with either a single 3.5-mm tricortical SS (22 patients) or an SB (21 patients). The mean follow-up was 7.1 years (range, 6.2-7.9). Syndesmosis reduction and OA grade was assessed with standing cone-beam computed tomography (CBCT) of both ankles. Malreduction was defined as >2 mm side-to-side difference in the mean width of the syndesmosis. OA was graded according to the Morrey & Wiedeman classification. The Olerud-Molander Ankle Outcome Score (OMAS) and a quality of life questionnaire (RAND 36-Item Health Survey) were used to evaluate functional outcome. RESULTS: Two syndesmoses in the SS group and one in the SB group were malreduced (P = 0.58). Moderate OA after a mean of 7 years post-injury was common. In the SS and SB groups, 9 of 16 and 11 of 13 patients, respectively, had one or more grades serious OA in the injured ankle than in the uninjured ankle (P = 0.11). The mean OMAS was 88 in the SS group and 78 in the SB group (difference between means 7.1, 95% CI: -7.0-21.1, P = 0.32). The RAND-36 results did not differ between groups. CONCLUSION: The SS and SB maintained syndesmosis reduction equally well during follow-up. Our study findings also suggest that both methods result in moderate OA rates and the functional outcome is comparable between these two syndesmosis fixation methods.

Difference in postoperative opioid consumption after spinal versus general anaesthesia for ankle fracture surgery-A retrospective cohort study.

BACKGROUND: Surgical treatment of ankle fracture is associated with significant pain and high postoperative opioid consumption. The anaesthesia method may affect early postoperative pain. The main objective of the study was to compare postoperative opioid consumption after ankle-fracture surgery between patients treated with spinal anaesthesia and general anaesthesia. METHODS: We reviewed retrospectively the files of 586 adult patients with surgically treated ankle fracture in the years 2014 through 2016. The primary outcome was opioid consumption during the first 48 postoperative hours. Secondary outcomes were maximal pain scores, postoperative nausea and vomiting, the length of stay in the post-anaesthesia care unit, and opioid use in different time periods up to 48 h postoperatively. Propensity score matching was used to mitigate confounding variables. RESULTS: Total opioid consumption 48 h postoperatively was significantly lower after spinal anaesthesia (propensity score-matched population: effect size -13.7 milligrams; 95% CI -18.8 to -8.5; P < .001). The highest pain score on the numerical rating scale in the post-anaesthesia care unit was significantly higher after general anaesthesia (propensity score-matched population: effect size 3.7 points; 95% CI 3.2-4.2; P < .001). A total of 60 patients had postoperative nausea and vomiting in the post-anaesthesia care unit, 53 (88.3%) of whom had general anaesthesia (P = .001). CONCLUSIONS: Patients with surgically treated ankle fracture whose operation was performed under general anaesthesia used significantly more opioids in the first 48 h postoperatively, predominantly in the post-anaesthesia care unit, compared with patients given spinal anaesthesia.

Surgery versus non-operative treatment for ER-stress unstable Weber-B unimalleolar fractures: a study protocol for a prospective randomized non-inferiority (Super-Fin) trial.

Roughly two-thirds of ankle fractures are unimalleolar injuries, the Weber B-type fibula fracture being by far the most common type. Depending on the trauma and the accompanying soft-tissue injury, these fractures are either stable or unstable. Current clinical practice guidelines recommend surgical treatment for unstable Weber B-type fibula fractures. An ongoing randomized, parallel group, non-inferiority trial comparing surgery and non-operative treatment for unstable Weber B-type ankle fractures with allocation ratio 1:1. The rationale for non-inferiority design is as follows: By being able to prove non-inferiority of non-operative treatment, we would be able to avoid complications related to surgery. However, the primary concern related to non-operative treatment is increased risks of ankle mortise incongruency, leading to secondary surgery, early post-traumatic osteoarthritis and poor function. After providing informed consent, 126 patients aged 16 years or older with an unimalleolar Weber B-type unstable fibula fracture were randomly assigned to surgery (open reduction and internal fixation) or non-operative treatment (6-week cast immobilization). We have completed the patient enrolment and are currently in the final stages of the 2-year follow-up. The primary, non-inferiority outcome is the Olerud-Molander Ankle Score (OMAS) at 2 years (primary time point). The predefined non-inferiority margin is set at 8 OMAS points. Secondary outcomes include the Foot and Ankle Score, a 100 mm Visual Analogue Scale for function and pain, the RAND-36-Item Health Survey for health-related quality-of-life, the range-of-motion of the injured ankle, malunion (ankle joint incongruity) and fracture union. Treatment-related complications and harms; symptomatic non-unions, loss of congruity of the ankle joint, reoperations and wound infections will also be recorded. We hypothesize that non-operative treatment yields non-inferior functional outcome to surgery, the current standard treatment, with no increased risk of harms.

Stability-Based Classification of Ankle Fractures-The Long-Term Outcome After 11-13 Years of Follow-up.

OBJECTIVES: To assess the long-term functional and radiological outcome, as well as complications and reoperations of ankle fracture patients treated based on stability classification. DESIGN: Retrospective. SETTING: Main Trauma Center, University Hospital. PATIENTS AND INTERVENTIONS: One hundred sixty patients were treated based on stability classification. After a mean follow-up of 12 years, 102 patients were assessed; 67 visited the outpatient clinic, and standard standing ankle radiographs were taken; osteoarthritis (OA) was graded according to Kellgren-Lawrence classification. The remaining patients (n = 35) were followed up via mail or telephone. The complications and reoperations of all 160 patients were collected from electronic patient records. MAIN OUTCOME MEASURES: Olerud-Molander ankle score, foot and ankle outcome score, visual analog scale, RAND-36 item health survey, range-of-motion measurements, and Kellgren-Lawrence OA classification. RESULTS: Very good to excellent ankle functional outcome was reported by 96% of the stable fracture group [mean Olerud-Molander ankle score (OMAS), 92; range, 20-100] and 82% of the unstable group (mean OMAS, 86; range, 30-100). For patients with an unstable fracture, OMAS and VAS pain scores significantly improved from 2 to 12 years, even though higher grades of radiologic OA were found. No patients with fractures deemed stable needed operative intervention even in the long-term follow-up. Instead, 30% of the operatively treated patients underwent reoperation during the long follow-up. CONCLUSIONS: The treatment of ankle fractures based on stability-based classification led to predictable, functionally good outcomes even during long-term follow-up. Ankle fractures can reliably be deemed stable based on this classification and treated without failures in the long term. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Fibular nailing for fixation of ankle fractures in patients at high risk of surgical wound infection.

BACKGROUND: Postoperative infection is a severe complication after operative treatment of ankle fractures, associated with age, comorbidities, and severe soft tissue injuries. We assessed the efficacy of intramedullary fibular nailing for treating ankle fractures in patients at high risk of wound complications. METHODS: 41 high-risk patients were included in the study. We retrospectively reviewed the medical records to assess the risk profile, the treatment data, and possible infections and re-operations. After a minimum of 2 years eight patients had died, three had advanced-staged dementia and two were lost to follow-up. Remaining 28 patients reported the functional outcome and QoL through patient-reported questionnaires. Radiographs and cone-beam computed tomography were performed, as well as range-of-motion was measured. RESULTS: No surgical wound infections were found. The mean Olerud-Molander score was 67 points (SD 28 [20-100]). The osteoarthritis stages and the range-of-motion were significantly different between the injured and uninjured ankles, but we detected no significant effect on the QoL. CONCLUSION: Intramedullary fibular fixation appeared to be a safe treatment choice for ankle fractures in high-risk patients. LEVEL OF EVIDENCE: IV.

Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial.

OBJECTIVE: To determine whether treatment of isolated stable Weber B type ankle fractures with a cast or a simple orthotic device for three weeks produces non-inferior outcomes compared with conventional immobilisation in a cast for six weeks. DESIGN: Randomised, pragmatic, non-inferiority, clinical trial with blinded outcome assessment. SETTING: Two major trauma centres in Finland, 22 December 2012 to 6 June 2016. PARTICIPANTS: 247 skeletally mature patients aged 16 years or older with an isolated Weber B type fibula fracture and congruent ankle mortise in static ankle radiographs. INTERVENTIONS: Participants were randomly allocated to conventional six week cast immobilisation (n=84) or three week treatment either in a cast (n=83) or in a simple orthosis (n=80). MAIN OUTCOME MEASURES: The primary, non-inferiority, intention-to-treat outcome was the Olerud-Molander Ankle Score at 12 months (OMAS; range 0-100; higher scores indicate better outcomes and fewer symptoms). The predefined non-inferiority margin for the primary outcome was -8.8 points. Secondary outcomes were ankle function, pain, quality of life, ankle motion, and radiographic outcome. Follow-up assessments were performed at 6, 12, and 52 weeks. RESULTS: 212 of 247 randomised participants (86%) completed the study. At 52 weeks, the mean OMAS was 87.6 (SD 18.3) in the six week cast group, 91.7 (SD 12.9) in the three week cast group, and 89.8 (SD 18.4) in the three week orthosis group. The between group difference at 52 weeks for the three week cast versus six week cast was 3.6 points (95% confidence interval -1.9 to 9.1, P=0.20), and for the three week orthosis versus six week cast was 1.7 points (-4.0 to 7.3, P=0.56). In both comparisons, the confidence intervals did not include the predefined inferiority margin of -8.8 points. The only statistically significant between group differences observed in the secondary outcomes and harms in the two primary comparisons were slight improvement in ankle plantar flexion and incidence of deep vein thrombosis, both in the three week orthosis group versus six week cast group. CONCLUSION: Immobilisation for three weeks with a cast or orthosis was non-inferior to conventional cast immobilisation for six weeks in the treatment of an isolated stable Weber B type fracture. TRIAL REGISTRATION: ClinicalTrials.gov NCT01758835.

The functional outcome and quality of life after treatment of isolated medial malleolar fractures.

BACKGROUND: The optimal treatment of isolated medial malleolar fractures is widely debated. The aim of this study is to analyse the different treatment methods. METHODS: The study included 137 patients with an isolated medial malleolar fracture treated at our hospital between 2000 and 2010. Functional outcome was assessed using Olerud-Molander score and health-related quality-of-life (HRQoL) was measured with RAND36 item health survey. Patients were sent follow-up questionnaires after an average of 9.5 years (4.3-15.2) from the date of treatment. RESULTS: The overall improvement in function was equivalent in both operative and non-operative treatment groups. However, the outcome scores declined in both groups as the primary displacement increased, regardless of the treatment method. HRQoL was similar in both groups. CONCLUSIONS: If maximal fracture displacement is ≤2mm, isolated medial malleolar fractures can be treated non-operatively with good outcome, but the operative treatment may also be performed without serious complications. The degree of fracture displacement is an independent risk factor for inferior functional result, regardless of the treatment method. LEVEL OF EVIDENCE: Therapeutic level of evidence: IV, retrospective cohort study.

A prospective randomised study comparing TightRope and syndesmotic screw fixation for accuracy and maintenance of syndesmotic reduction assessed with bilateral computed tomography.

BACKGROUND: The accuracy and maintenance of syndesmosis reduction are essential when treating ankle fractures with accompanying syndesmosis injuries. The primary aim of this study was to compare syndesmosis screw and TightRope fixation in terms of accuracy and maintenance of syndesmosis reduction using bilateral computed tomography (CT). STUDY DESIGN: Single centre, prospective randomised controlled clinical trial; Level of evidence 1. METHODS: This study (ClinicalTrials.gov, NCT01742650) compared fixation with TightRope(®) (Arthrex, Naples, FL, USA) or with one 3.5-mm tricortical trans-syndesmotic screw in terms of accuracy and maintenance of syndesmosis reduction in Lauge-Hansen pronation external rotation, Weber C-type ankle fractures with associated syndesmosis injury. Twenty-one patients were randomised to TightRope fixation and 22 to syndesmotic screw fixation. Syndesmosis reduction was assessed using bilateral CT intraoperatively or postoperatively, and also at least 2 years after surgery. Functional outcomes and quality of life were assessed using the Olerud-Molander score, a 100-mm Visual Analogue Scale, the Foot and Ankle Outcome Score, and the RAND 36-Item Health Survey. Grade of osteoarthritis was qualified with follow-up cone-beam CT. RESULTS: According to surgeons' assessment from intraoperative CT, screw fixation resulted in syndesmosis malreduction in one case whereas seven syndesmosis were considered malreduced when TightRope was used. However, open exploration and postoperative CT of these seven cases revealed that syndesmosis was well reduced if the ankle was supported at 90˚. Retrospective analysis of the intra- and post-operative CT by a radiologist showed that one patient in each group had incongruent syndesmosis. Follow-up CT identified three patients with malreduced syndesmosis in the syndesmotic screw fixation group, whereas malreduction was seen in one patient in the TightRope group (P = 0.33). Functional scores and the incidence of osteoarthritis showed no significant difference between groups. CONCLUSION: Syndesmotic screw and TightRope had similar postoperative malreduction rates. However, intraoperative CT scanning of ankles with TightRope fixation was misleading due to dynamic nature of the fixation. After at least 2 years of follow-up, malreduction rates may slightly increase when using trans-syndesmotic screw fixation, but reduction was well maintained when fixed with TightRope. Neither the incidence of ankle joint osteoarthritis nor functional outcome significantly differed between the fixation methods.

Effect of syndesmosis injury in SER IV (Weber B)-type ankle fractures on function and incidence of osteoarthritis.

BACKGROUND: Syndesmosis fixation of Lauge-Hansen SER IV, Weber B ankle fractures is controversial. This study compared a matched pair of SER IV patients with stress proven syndesmotic injuries with the same number without stress proven syndesmotic injury in terms of functional, pain, and radiologic result. METHODS: The study was based on a RCT-study comparing syndesmotic transfixation to no fixation in SER IV (Weber B)-type ankle fractures. Twenty-four patients with a syndesmosis injury found on the intraoperative 7.5 Nm standardized external rotation test were compared to 24 patients with a stable syndesmosis. The pairs were matched by fracture morphology, sex, and age. The primary outcome measure was ankle function as assessed by the Olerud-Molander score. Weight-bearing plain radiographs and 3T MRI of the injured ankle were used to assess ankle joint congruity and osteoarthritis, according to Kellgren-Lawrence classification and cartilage defects. RESULTS: The Olerud-Molander score was 86 in syndesmosis injury patients and 90 in patients with normal syndesmosis (P = .28). The incidence of ankle joint osteoarthritis on plain radiographs was not significantly different between the groups (Grade I 5% vs 21%; Grade II 86% vs 75%; Grade III 9% vs 4%; P = .34). MRI scans showed TC joint cartilage defects in 54% of the patients: 12 (56%) in the syndesmosis injury group vs 13 (54%) in the group without syndesmosis injury (P > .9). CONCLUSION: After 4 to 6 years of follow-up, clinical and radiologic outcome were not different in patients with syndesmosis injury compared to patients with stable syndesmosis in SER IV (Weber B)-type ankle fractures. LEVEL OF EVIDENCE: Prognostic Level II, comparative study.

Stability assessment of the ankle mortise in supination-external rotation-type ankle fractures: lack of additional diagnostic value of MRI.

BACKGROUND: This prospective diagnostic study assessed the utility of MRI (magnetic resonance imaging) findings for the deep aspect of the deltoid ligament in evaluating the stability of the ankle mortise in patients who have an SER (supination-external rotation)-type lateral malleolar fracture with no widening of the medial clear space. METHODS: Sixty-one patients with a unilateral lateral malleolar fracture resulting from an SER mechanism were enrolled. Two surgeons assessed the stability of the ankle mortise with use of an external-rotation stress test. The anterior and posterior parts of the deep deltoid ligament were investigated with 3.0-T MRI and were graded (as normal, edematous, partial tear, or complete tear) by two musculoskeletal radiologists. The medial clear space was measured and compared with the MRI findings for the deep deltoid ligament in stable and unstable injuries. Interobserver reliability was calculated for both external-rotation stress testing and MRI assessment. RESULTS: Thirty-three patients had a medial clear space of ≥ 5 mm in the external-rotation stress test. According to MRI, all of these patients had an injury involving the deep deltoid ligament (an edematous ligament in five, a partial tear in twenty-six, and a total tear in two). Twenty-eight patients had a medial clear space of <5 mm, and MRI indicated a deep deltoid ligament injury in all of these patients as well (an edematous ligament in nine and a partial tear in nineteen). The medial clear space increased according to the severity of the deep deltoid ligament injury as indicated by MRI (p < 0.001). The interobserver agreement of the external-rotation stress test was excellent (94% agreement; kappa = 0.87), whereas the interobserver reliability of the MRI assessments by the two musculoskeletal radiologists was fair to moderate (72% agreement for the posterior part of the deep deltoid ligament and 56% for the anterior part; kappa = 0.46 and 0.22, respectively). CONCLUSIONS: On the basis of the study results, we do not recommend the use of MRI when choosing between operative and nonoperative treatment of an SER-type ankle fracture.

Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study.

BACKGROUND: This study compared mid-term functional and radiologic results of syndesmotic transfixation with no fixation in supination external rotation (SER) ankle fractures with intraoperatively confirmed syndesmosis disruption. Our hypothesis was that early-stage good functional results would remain and unfixed syndesmosis disruption in SER IV ankle fractures would not lead to an increased incidence of osteoarthritis. METHODS: A prospective study of 140 operatively treated patients with Lauge-Hansen SER IV (Weber B) ankle fractures was performed. After bony fixation, the 7.5-Nm standardized external rotation stress test for both ankles was performed under fluoroscopy. A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. The patients were randomized to either syndesmotic screw fixation (13 patients) or no syndesmotic fixation (11 patients). After a minimum of 4 years of follow-up (mean, 58 months), ankle function and pain (Olerud-Molander, a 100-mm visual analogue scale [VAS] for ankle function and pain) and quality of life (RAND-36) of all 24 patients were assessed. Ankle joint congruity and osteoarthritis were assessed using mortise and lateral projection plain weight-bearing radiographs and magnetic resonance imaging (MRI; 3T) scans. RESULTS: Improvement in Olerud-Molander score, VAS, and RAND-36 showed no significant difference between groups during the follow-up. In the syndesmotic transfixation group, improvements in all functional parameters and pain measurements were not significant, whereas in the group without syndesmotic fixation, the Olerud-Molander score improved from 84 to 93 (P = .007) and the pain (VAS) score improved from 11 to 4 (P = .038) from 1 year to last follow-up. X-ray or MRI imaging showed no difference between groups at the last follow-up visit. CONCLUSION: With the numbers available, no significant difference in functional outcome or radiologic findings could be detected between syndesmosis transfixation and no-fixation patients with SER IV ankle fracture after a minimum of 4 years of follow-up. LEVEL OF EVIDENCE: Level II, prospective comparative study.