scholarly journals Is postoperative non-weight-bearing necessary? INWN Study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ramy Khojaly ◽  
Ruairí Mac Niocaill ◽  
Muhammad Shahab ◽  
Matthew Nagle ◽  
Colm Taylor ◽  
...  

Abstract Background Postoperative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. There is an evolving understanding that extended periods of immobilisation and weight-bearing limitation may lead to poorer clinical outcomes. Traditional non-weight-bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. Methods A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 h versus non-weight-bearing (NWB) and immobilisation in a cast for 6 weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury) is proposed. All patients presenting to three trauma units will be included. The exclusion criteria will be skeletal immaturity and tibial plafond fractures. The three institutional review boards have granted ethical approval. The primary outcome measure will be the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. The trial will be reported in accordance with the CONSORT statement for reporting a pragmatic trial, and this protocol will follow the SPIRIT guidance. Discussion Traditional management of operatively treated ankle fractures includes an extended period of non-weight-bearing. There is emerging evidence that earlier weight-bearing may have equivocal outcomes and favourable patient satisfaction but higher wound-related complications. These studies often preclude more complicated fracture patterns or patient-related factors. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. This pragmatic randomised-controlled multicentre trial will investigate immediate weight-bearing following ORIF of all ankle fracture patterns in the usual care condition. It is hoped that these results will contribute to the modern management of ankle fractures. Trial registration ISRCTN Registry ISRCTN76410775. Retrospectively registered on 30 June 2019.

2020 ◽  
Author(s):  
Ramy Elmahy Khojaly ◽  
Ruairi Mac Niocaill ◽  
Muhammad Shahab ◽  
Matthew Nagle ◽  
Colm Taylor ◽  
...  

Abstract Background:Postoperative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. There is an evolving understanding that extended periods of immobilisation and limitation of weight-bearing may lead to poorer clinical outcomes. Traditional non-weight bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates.Methods:A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus non-weight-bearing (NWB) and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury) is proposed. All patients presenting to three trauma units will be included. The exclusion criteria will be skeletal immaturity and tibial plafond fractures. The three institutional review boards have granted ethical approval. The primary outcome measure will be the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes included wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. The trial will be reported in accordance with the CONSORT statement for reporting a pragmatic trial, and this protocol will follow the SPIRIT guidance.Discussion:Traditional management of operatively treated ankle fractures includes an extended period of non-weight bearing. There is emerging evidence that earlier weight-bearing may have equivocal outcomes and favourable patient satisfaction but with higher wound-related complications. These studies often preclude more complicated fracture patterns or patient-related factors. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. This pragmatic randomised-controlled multicentre trial will investigate immediate weight-bearing following ORIF of all ankle fracture patterns in the usual condition of care. It is hoped that these results will contribute to the modern management of ankle fractures.Trial registration:The trial is retrospectively registered on the 30th of June 2019, ISRCTN - ISRCTN76410775.http://www.isrctn.com/ISRCTN76410775


2020 ◽  
Author(s):  
Ramy Elmahy Khojaly ◽  
Ruairi Mac Niocaill ◽  
Muhammad Shahab ◽  
Matthew Nagle ◽  
Colm Taylor ◽  
...  

Abstract Background:Postoperative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. There is an evolving understanding that extended periods of immobilisation and limitation of weight-bearing may lead to poorer clinical outcomes. Traditional non-weight bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates.Methods:A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus non-weight-bearing (NWB) and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury) is proposed. All patients presenting to three trauma units will be included. The exclusion criteria will be skeletal immaturity and tibial plafond fractures. The three institutional review boards have granted ethical approval. The primary outcome measure will be the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes included wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. The trial will be reported in accordance with the CONSORT statement for reporting a pragmatic trial, and this protocol will follow the SPIRIT guidance.Discussion:Traditional management of operatively treated ankle fractures includes an extended period of non-weight bearing. There is emerging evidence that earlier weight-bearing may have equivocal outcomes and favourable patient satisfaction but with higher wound-related complications. These studies often preclude more complicated fracture patterns or patient-related factors. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. This pragmatic randomised-controlled multicentre trial will investigate immediate weight-bearing following ORIF of all ankle fracture patterns in the usual condition of care. It is hoped that these results will contribute to the modern management of ankle fractures.Trial registration:The trial is retrospectively registered on the 30th of June 2019, ISRCTN - ISRCTN76410775.http://www.isrctn.com/ISRCTN76410775


2020 ◽  
Author(s):  
Ramy E Khojaly ◽  
Ruairí Mac Niocaill ◽  
Muhammad Shahab ◽  
Matthew Nagle ◽  
Colm Taylor ◽  
...  

Abstract Background:Postoperative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. There is an evolving understanding that extended periods of immobilisation and limitation of weight-bearing may lead to poorer clinical outcomes. Traditional non-weight bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates.Methods:A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus non-weight-bearing (NWB) and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury) is proposed. All patients presenting to three trauma units will be included. The exclusion criteria will be skeletal immaturity and tibial plafond fractures. The three institutional review boards have granted ethical approval. The primary outcome measure will be the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes included wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. The trial will be reported in accordance with the CONSORT statement for reporting a pragmatic trial, and this protocol will follow the SPIRIT guidance.Discussion:Traditional management of operatively treated ankle fractures includes an extended period of non-weight bearing. There is emerging evidence that earlier weight-bearing may have equivocal outcomes and favourable patient satisfaction but with higher wound-related complications. These studies often preclude more complicated fracture patterns or patient-related factors. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. This pragmatic randomised-controlled multicentre trial will investigate immediate weight-bearing following ORIF of all ankle fracture patterns in the usual condition of care. It is hoped that these results will contribute to the modern management of ankle fractures.Trial registration:The trial is retrospectively registered on the 30th of June 2019, ISRCTN - ISRCTN76410775.http://www.isrctn.com/ISRCTN76410775


2020 ◽  
Author(s):  
Ramy E Khojaly ◽  
Ruairí Mac Niocaill ◽  
Muhammad Shahab ◽  
Danilo Vukanic ◽  
Matthew Nagle ◽  
...  

Abstract Background Post-operative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. There is an evolving understanding that extended periods of immobilisation and limitation of weight-bearing may lead to poorer clinical outcomes. Traditional non-weight bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rate. Methods A pragmatic randomised controlled multi-centre trial, comparing IWB in a walking boot and ROM within 24 hours versus non-weight bearing (NWB) and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury) is proposed. All patients presenting to three trauma units will be included. Exclusion criteria will be skeletal immaturity and tibial plafond fractures. The three institutional review boards have granted ethical approval. The primary outcome measure will be the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include; Wound infection (deep and superficial), displacement of osteosynthesis, total arc of ankle motion (plantar flexion and dorsal-flection), RAND 36-Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. The trial will be reported in accordance with the CONSORT statement for reporting a pragmatic trial and this protocol follow the SPIRIT guidance. Discussion Traditional management of operatively treated ankle fractures includes an extended period of non-weight bearing. There is emerging evidence that earlier weight-bearing may have equivocal outcomes and favourable patient satisfaction but with higher wound-related complications. These studies often preclude more complicated fracture patterns or patient-related factors. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner. This pragmatic randomised-controlled multi-centre trial will investigate immediate weight-bearing following ORIF of all ankle fractures pattern in the usual condition of care. It is hoped that these results will contribute towards the modern management of ankle fractures.


2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0018
Author(s):  
Bonnie Chien ◽  
Kristen Stupay ◽  
Christopher Miller ◽  
Jeremy Smith ◽  
Jorge Briceno ◽  
...  

Category: Trauma Introduction/Purpose: Prompt reduction and stabilization of displaced ankle fractures is important to protect soft tissues, restore potential neurovascular deficits and prevent cartilage injury. Many of these injuries do eventually require surgical fixation. The purpose of this study is to determine whether the initial quality of ankle closed reduction based on radiographic criteria would affect outcomes such as ankle osteoarthritis and complications after surgery. Furthermore, we sought to develop a classification system for the quality of closed reduction that would be easy to use and provide interrater reliability. Methods: A retrospective analysis of patients who sustained isolated, closed ankle fractures with at least 3 months follow up postoperatively at two level 1 trauma centers was performed. Patient demographics and history, ankle fracture characteristics and reduction information as well as surgical outcomes and complications were collected. A grading classification for the quality of the initial closed reduction before surgery was developed based on standard AP or mortise and lateral ankle x-rays. The factors considered for rating the reduction included the degree of talar shift on the AP/mortise view, malleoli displacement, as well the relationship of a central plumb line to the center of the talar dome on the lateral x-ray. For ankle osteoarthritis, the Takakura classification was utilized. Three reviewers (1 resident, 2 attendings) independently reviewed and rated all imaging. Results: 161 patients were analyzed. 65% female, average age 50, average 4 days between injury and surgery, mean follow up of 12 months (3-58 months), and 17% wound complications. Psychiatric history was the single comorbidity significantly associated with complications (p=0.009). There was no difference in wound or infection complication rates based on initial closed reduction quality (p=0.17). Neither number nor quality of reductions correlated with increased osteoarthritis (p=0.19, 0.39 respectively). Worst graded reductions had shorter time to surgery, mean 1.4 vs 4.7 days for best reductions (p=0.03), suggesting a protective factor that may account for no association between reduction quality and wound complications. Interclass correlation coefficients for multiple observers showed very high consistency for grading of reduction quality based on the classification system (ICC >0.85, p<0.001). Conclusion: It is often emphasized that a displaced ankle fracture should be as perfectly reduced as possible, understandably for grossly dislocated ankle fracture dislocations potentially compromising skin and neurovascular structures. At the same time, this original study demonstrated contrary to common assumption that the initial quality of ankle closed reduction does not appear to affect the severity of ankle osteoarthritis or the rate of surgical complications. This study also developed a highly reproducible ankle reduction classification system. It opens the opportunity for future prospective application and analysis of this classification’s ultimate clinical utility.


2018 ◽  
Vol 39 (7) ◽  
pp. 850-857 ◽  
Author(s):  
Mark C. Lawlor ◽  
Melissa A. Kluczynski ◽  
John M. Marzo

Background: The utility of computed tomography (CT) for measuring medial clear space (MCS) for determination of the stability of supination external rotation (SER) ankle fractures and in comparison to standard radiographs is unknown. We compared MCS on gravity stress (GS) radiographs to GS and weight bearing (WB) cone-beam CT (CBCT). Methods: An AO SER 44B3.1 ankle fracture was simulated in 10 human cadavers, also serving as controls. MCS was measured on GS radiographs, GS CBCT, and a simulated WB CBCT scan. Specimens were stable if MCS was <5 mm and unstable if MCS was ≥5 mm. Paired t tests were used to compare MCS from each imaging modality for controls versus SER injuries and stable versus unstable specimens. Results: Compared with controls assessed by GS radiographs, MCS was greater for an SER injury when assessed by GS radiograph and GS CBCT scan within the stable group. Compared with controls assessed by GS radiographs, MCS was greater for SER injuries when assessed by GS radiograph, GS CBCT scan, and WB CBCT within the unstable group. MCS was reduced for stable versus unstable SER injuries assessed by WB CBCT. Conclusion: In a cadaveric model of SER ankle fracture, the medial clear space was statistically significantly greater for the experimental condition when assessed by gravity stress radiograph and gravity stress CBCT scan. Under weight-bearing conditions, the cone-beam CT scanner distinguished between stable and unstable ankles in the experimental condition. Clinical Relevance: This study suggests that a WB cone-beam CT scan may be able to distinguish between stable and unstable SER ankle fractures and influence operative decision making.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
C. P. Bretherton ◽  
H. A. Claireaux ◽  
J. Achten ◽  
A. Athwal ◽  
S. J. Dutton ◽  
...  

Abstract Background Unstable ankle fractures represent a substantial burden of disease, accounting for a mean hospital stay of nine days, a mean cost of £4,491 per patient and 20,000 operations per year. There is variation in UK practice around weight-bearing instructions after operatively managed ankle fracture. Early weight-bearing may reduce reliance on health services, time off work, and improve functional outcomes. However, concerns remain about the potential for complications such as implant failure. This is the protocol of a multicentre randomised non-inferiority clinical trial of weight-bearing following operatively treated ankle fracture. Methods Adults aged 18 years and over who have been managed operatively for ankle fracture will be assessed for eligibility. Baseline function (Olerud and Molander Ankle Score [OMAS]), health-related quality of life (EQ-5D-5L), and complications will be collected after informed consent has been obtained. A randomisation sequence has been prepared by a trial statistician to allow for 1:1 allocation to receive either instruction to weight-bear as pain allows from the point of randomisation, two weeks after the time of surgery (‘early weight-bearing’ group) or to not weight-bear for a further four weeks (‘delayed weight -bearing’ group). All other treatment will be as per the guidance of the treating clinician. Participants will be asked about their weight-bearing status weekly until four weeks post-randomisation. At four weeks post-randomisation complications will be collected. At six weeks, four months, and 12 months post-randomisation, the OMAS, EQ-5D-5L, complications, physiotherapy input, and resource use will be collected. The primary outcome measure is ankle function (OMAS) at four months post-randomisation. A minimum of 436 participants will be recruited to obtain 80% power to detect a non-inferiority margin of -6 points on the OMAS 4 months post-randomisation. A within-trial health economic evaluation will be conducted to estimate the cost-effectiveness of the treatment options. Discussion The results of this study will inform national guidance with regards to the most clinically and cost-effective strategy for weight-bearing after surgery for unstable ankle fractures. Trial registration ISRCTN12883981, Registered 02 December 2019.


2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0021
Author(s):  
Brianna R. Fram ◽  
Ryan G. Rogero ◽  
Daniel Corr ◽  
Gerard Chang ◽  
James Krieg ◽  
...  

Category: Ankle; Trauma Introduction/Purpose: Ankle fractures are the third most common adult fractures. Further, they are the second most common fracture type to require inpatient admission, behind only hip fractures, despite occurring in a population on average nearly 30 years younger. There is evidence that early or immediate weight bearing and range of motion may be safe following ankle fracture fixation, but existing studies are small and largely exclude patients with syndesmotic or posterior malleolar fixation. We therefore studied the safety of immediate weight bearing as tolerated (IWBAT) and immediate range of motion (IROM) following open reduction internal fixation (ORIF) of unstable ankle fractures in a diverse cohort and attempted to identify risk factors for complications. Methods: We performed a retrospective case-control study. Out of 268 patients who underwent primary ORIF of an unstable ankle fracture from 2013-18, we identified 133 (49.6%) who were IWBAT and IROM. The treating surgeon excluded patients from IWBAT if they had an ipsilateral leg injury requiring non-weight bearing, a large displaced posterior malleolus fragment, or Maisonneuve injury with fracture of the proximal fibula. We used propensity-score matching to identify 172 controls who were non-weight bearing (NWB) and no range of motion for 6 weeks post-op. We reviewed medical records and radiographs for demographic, injury and treatment characteristics. Our primary outcome was complications. We compared demographics, injury characteristics, treatment episode, and complications between the IWBAT and NWB groups and performed within group analysis to identify risk factors for complications. A p-value <0.05 was considered significant. Results: The groups did not differ significantly in age, BMI, Charleston Comorbidity Index (CCI), smoking status, diabetes status, malleoli involved, percentages undergoing medial malleolus (60.9% IWBAT vs. 51.7% NWB, p=0.11), posterior malleolus (24.1% IWBAT, 26.7% NWB, p=0.59), or syndesmosis fixation (41.4% IWBAT, 42.4% NWB, p=0.85). There was no significant difference in total complications (9.8% IWBAT vs. 12.8% NWB, p=0.41), nonoperative complications (6.8% IWBAT vs. 8.7% NWB, p=0.53), or operative complications (3.8% IWBAT vs. 4.1% NWB, p=0.89). We did not identify any factors associated with increased complication risk, including posterior malleolus or syndesmosis fixation, diabetes, age, CCI or pre-injury assisted ambulation. Conclusion: IWBAT and IROM may be safe following ankle fracture ORIF in a broader patient population than previously believed. We did not identify specific risk factors for post-operative complications. Further study on patient selection may allow for more extensive use of this protocol to reduce the morbidity associated with unstable ankle fractures. [Table: see text]


2012 ◽  
Vol 7 (1) ◽  
pp. 40-46
Author(s):  
KP Paudel

Ankle fractures are the most common types of fractures treated in orthopaedics. When to begin ankle movement and weight bearing and the type of immobilizing devices to use post-operatively have had more intense clinical study than most other aspects of ankle fracture treatment. Aim of this study is to compare the results of two functional methods of post-operative treatment in internally fixed ankle fractures, i.e. one after early weight bearing using walking plaster and the other after non-weight bearing functional mobilization in the first six weeks following stable internal fixation. This is a prospective, non-randomized study. Between March 2004 and February 2006, thirty- five patients with displaced ankle fractures treated by internal fixation were assigned in a way that every alternate patient fell in different groups. Group A patients, 17, were managed with a below-knee walking plaster and group B patients, 18 with non-weight bearing mobilization with crutches. Five patients were lost in follow up and 30 were followed regularly as in the protocol. There was a temporary benefit in subjective evaluation (63 v 48 points, student t test. P=0.262), return to work (53.8 v 72.9 days, student t test, p=0.079) for those with a below-knee walking plaster at six week. There were minimal differences between the groups in the loss of dorsal range of movement (14.7 v 13.1 degree) or in the overall clinical results at the first follow up. But the differences disappeared in any evaluation after three months. Both treatments were considered to be satisfactory and the treatment choice depends on the ability to mobilize or weight bearing, the type of work and personal preference. DOI: http://dx.doi.org/10.3126/jcmsn.v7i1.5972 JCMSN 2011; 7(1): 40-46


2008 ◽  
Vol 37 (2) ◽  
pp. 106-113
Author(s):  
Boris Bacic ◽  
Philippe Gicquel ◽  
Marie-Christine Giacomelli ◽  
Claud Karger ◽  
Jean-Michel Clavert

The biomechanical differences between mature and immature bones, as well as the differing forces applied to those bones, help explain the differences between adult and pediatric fractures. The potential complications associated with pediatric ankle fractures include those seen with adult fractures (such as posttraumatic arthritis, stiffness, and reflex sympathet-ic dystrophy) as well as those that result from physeal damage (including leg-length discrepancy, angular deformity). The goals of treatment are to achieve and maintain a satisfactory reduction and to avoid physeal arrest. A knowledge of common pediatric ankle fracture patterns and the pitfalls associated with their evaluation and treatment will aid in the effective management of these injuries.


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