Dataset Information

Use of cast immobilisation versus removable brace in adults with an ankle fracture: multicentre randomised controlled trial.

ABSTRACT:

Objectives

To assess function, quality of life, resource use, and complications in adults treated with plaster cast immobilisation versus a removable brace for ankle fracture.

Design

Multicentre randomised controlled trial.

Setting

20 trauma units in the UK National Health Service.

Participants

669 adults aged 18 years and older with an acute ankle fracture suitable for cast immobilisation: 334 were randomised to a plaster cast and 335 to a removable brace.

Interventions

A below the knee cast was applied and ankle range of movement exercises started on cast removal. The removable brace was fitted, and ankle range of movement exercises were started immediately.

Main outcome measures

Primary outcome was the Olerud Molander ankle score at 16 weeks, analysed by intention to treat. Secondary outcomes were Manchester-Oxford foot questionnaire, disability rating index, quality of life, and complications at 6, 10, and 16 weeks.

Results

The mean age of participants was 46 years (SD 17 years) and 381 (57%) were women. 502 (75%) participants completed the study. No statistically significant difference was found in the Olerud Molander ankle score between the cast and removable brace groups at 16 weeks (favours brace: 1.8, 95% confidence interval -2.0 to 5.6). No clinically significant differences were found in the Olerud Molander ankle scores at other time points, in the secondary unadjusted, imputed, or per protocol analyses.

Conclusions

Traditional plaster casting was not found to be superior to functional bracing in adults with an ankle fracture. No statistically difference was found in the Olerud Molander ankle score between the trial arms at 16 weeks.

Trial registration

ISRCTN registry ISRCTN15537280.

SUBMITTER: Kearney R

PROVIDER: S-EPMC8256800 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ObjectivesTo estimate the cost-effectiveness of using a removable boot versus a cast following ankle fracture from the National Health Service and Personal Social Services (NHS+PSS) payer and societal perspectives and explore the impact of both treatments on participants' activities of daily living.DesignCost-effectiveness analyses and qualitative interviews performed alongside a pragmatic multicentre randomised controlled trial.SettingEight UK NHS secondary care trusts.Participants243 participants (60.5% female, on average 48.2 years of age (SD 16.4)) with ankle fracture. Qualitative interviews with 16 participants. Interventions removable air boot versus plaster cast 2 weeks after surgery weight bearing as able with group-specific exercises.Primary and secondary outcome measuresQuality-adjusted life years (QALYs) estimated from the EQ-5D-5L questionnaire, costs and incremental net monetary benefit statistics measured 12 weeks after surgery, for a society willing-to-pay £20 000 per QALY.ResultsCare in the boot group cost, on average, £88 (95% CI £22 to £155) per patient more than in the plaster group from the NHS+PSS perspective. When including all societal costs, the boot saved, on average, £676 per patient (95% CI -£337 to £1689). Although there was no evidence of a QALY difference between the groups (-0.0020 (95% CI -0.0067 to 0.0026)), the qualitative findings suggest participants felt the boot enhanced their quality of life. Patients in the boot felt more independent and empowered to take on family responsibilities and social activities.ConclusionsWhile the removable boot is slightly more expensive than plaster cast for the NHS+PSS payer at 12 weeks after surgery, it reduces productivity losses and the need for informal care while empowering patients. Given that differences in QALYs and costs to the NHS are small, the decision to use a boot or plaster following ankle surgery could be left to patients' and clinicians' preferences.Trial registration numberISRCTN15497399, South Central-Hampshire A Research Ethics Committee (reference 14/SC/1409).

Project description:ObjectiveTo 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.DesignRandomised, pragmatic, non-inferiority, clinical trial with blinded outcome assessment.SettingTwo major trauma centres in Finland, 22 December 2012 to 6 June 2016.Participants247 skeletally mature patients aged 16 years or older with an isolated Weber B type fibula fracture and congruent ankle mortise in static ankle radiographs.InterventionsParticipants 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 measuresThe 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.Results212 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.ConclusionImmobilisation 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 registrationClinicalTrials.gov NCT01758835.

Project description:BackgroundPatients with Achilles tendon rupture who have non-operative treatment have traditionally been treated with immobilisation of the tendon in plaster casts for several weeks. Functional bracing is an alternative non-operative treatment that allows earlier mobilisation, but evidence on its effectiveness and safety is scarce. The aim of the UKSTAR trial was to compare functional and quality-of-life outcomes and resource use in patients treated non-operatively with plaster cast versus functional brace.MethodsUKSTAR was a pragmatic, superiority, multicentre, randomised controlled trial done at 39 hospitals in the UK. Patients (aged ≥16 years) who were being treated non-operatively for a primary Achilles tendon rupture at the participating centres were potentially eligible. The exclusion criteria were presenting more than 14 days after injury, previous rupture of the same Achilles tendon, or being unable to complete the questionnaires. Eligible participants were randomly assigned (1:1) to receive a plaster cast or functional brace using a centralised web-based system. Because the interventions were clearly visible, neither patients nor clinicians could be masked. Participants wore the intervention for 8 weeks. The primary outcome was patient-reported Achilles tendon rupture score (ATRS) at 9 months, analysed in the modified intention-to-treat population (all patients in the groups to which they were allocated, excluding participants who withdrew or died before providing any outcome data). The main safety outcome was the incidence of tendon re-rupture. Resource use was recorded from a health and personal social care perspective. The trial is registered with ISRCTN, ISRCTN62639639.FindingsBetween Aug 15, 2016, and May 31, 2018, 1451 patients were screened, of whom 540 participants (mean age 48·7 years, 79% male) were randomly allocated to receive plaster cast (n=266) or functional brace (n=274). 527 (98%) of 540 were included in the modified intention-to-treat population, and 13 (2%) were excluded because they withdrew or died before providing any outcome data. There was no difference in ATRS at 9 months post injury (cast group n=244, mean ATRS 74∙4 [SD 19∙8]; functional brace group n=259, ATRS 72∙8 [20∙4]; adjusted mean difference -1∙38 [95% CI -4∙9 to 2∙1], p=0·44). There was no difference in the rate of re-rupture of the tendon (17 [6%] of 266 in the plaster cast group vs 13 [5%] of 274 in the functional brace group, p=0·40). The mean total health and personal social care cost was £1181 for the plaster cast group and £1078 for the functional bract group (mean between-group difference -£103 [95% CI -289 to 84]).InterpretationTraditional plaster casting was not found to be superior to early weight-bearing in a functional brace, as measured by ATRS, in the management of patients treated non-surgically for Achilles tendon rupture. Clinicians may consider the use of early weight-bearing in a functional brace as a safe and cost-effective alternative to plaster casting.FundingUK National Institute for Health Research Health Technology Assessment Programme.

Project description:INTRODUCTION:Up to 30% of patients with a dislocated distal radial fracture (DRF) treated with closed reduction and cast immobilisation suffer from long-term functional restrictions. It remains unclear, whether duration of cast immobilisation influences functional outcome. The aim of this study is to evaluate whether the functional outcome of dislocated DRFs could be improved by shortening the period of immobilisation. METHODS AND ANALYSIS:A single blinded multicentre randomised controlled trial is initiated. Four weeks of plaster cast immobilisation is compared with six week plaster cast immobilisation in adult patients with adequate reduced DRFs. Primary outcome parameters are functional outcome measured with the Patient Rated Wrist Evaluation after 1 year of follow-up (FU). Secondary outcomes are: Disability of Arm, Shoulder and Hand Score after 1 year, 36-Item Short Form Health Survey after 1 year, functional outcome earlier in FU (6 weeks, 12 weeks and 6 months), range of motion, pain level and complications: number of re-interventions, secondary dislocation, delayed and non-union. ETHICS AND DISSEMINATION:The medical ethical committee VUmc approved the study protocol (2018.004, NL62861.029.17). The expectation of this study is that a shorter duration of plaster cast immobilisation is beneficial. This risk of specific complications is low and generally similar in both treatment options. FU is standardised according to current trauma guidelines. Present literature indicates that both treatment options that are used within this study are accepted protocols for treatment of dislocated DRFs. This trial will provide Level-I evidence for the comparison of functional outcome between the two treatment options for dislocated DRFs. Results of this study are expected to be published as a prospective, multicentre, randomised controlled trial article in 2021. TRIAL REGISTRATION:The Netherlands National Trial Register: NTR 6600, ABR: NL62861.029.17. Medical Ethical Committee VUmc registration number: 2018.004.

Project description:IntroductionOpen reduction and internal fixation with volar locking plate has become the most common fixation method in the treatment of unstable distal radius fracture (DRF). There is, however, no consensus as to whether or for how long a wrist should be immobilised after operative treatment. To date, there have been relatively few studies that have evaluated the effect of immediate postoperative mobilisation on functional outcomes. The aim of postoperative rehabilitation is to obtain a good function and to reduce impairment, recovery time, socioeconomical costs and absence from work. Therefore, there is a need for studies that evaluate the optimal method of postoperative rehabilitation to optimise wrist function and return to work.Methods and analysisThis study is a prospective, randomised, controlled trial in which a total of 240 working-age patients who undergo volar plating for DRF will be randomly assigned to either an early mobilisation group or a postoperative 2-week casting group. The aim of the study will be to compare early postoperative outcomes between the study groups. The primary outcome will be patient-rated wrist evaluation at 2 months after operation. A coprimary outcome will be the total length of sick leave. Our follow-up period will be 1 year, and secondary outcomes will include pain, patient satisfaction, perceived ability to work and complications identified at different time points. We expect those patients who undergo immediate mobilisation will have at least as rapid a return to work and function as those patients who undergo postoperative immobilisation, indicating/meaning that there will be no need for postoperative casting.Ethics and disseminationThis study will be conducted according to the Standard Protocol Items: Recommendations for Interventional Trials statement. The Ethics committee of Tampere University Hospital has approved the protocol. Ethics committee approval number is R21111, and it is accepted on 7 September 2021. The results of this study will be submitted for publication in peer-reviewed journals.Trial registration numberNCT05150925.

Project description:ObjectiveTo assess wrist function, quality of life, and complications in adult patients with a dorsally displaced fracture of the distal radius, treated with either a moulded cast or surgical fixation with K-wires.DesignMulticentre randomised clinical superiority trial, SETTING: 36 hospitals in the UK National Health Service (NHS).Participants500 adults aged 16 or over with a dorsally displaced fracture of the distal radius, randomised after manipulation of their fracture (255 to moulded cast; 245 to surgical fixation).InterventionsManipulation and moulded cast was compared with manipulation and surgical fixation with K-wires plus cast. Details of the application of the cast and the insertion of the K-wires were at the discretion of the treating surgeon, according to their normal clinical practice.Main outcome measuresThe primary outcome measure was the Patient Rated Wrist Evaluation (PRWE) score at 12 months (five questions about pain and 10 about function and disability; overall score out of 100 (best score=0 and worst score=100)). Secondary outcomes were PRWE score at three and six months, quality of life, and complications, including the need for surgery due to loss of fracture position in the first six weeks.ResultsThe mean age of participants was 60 years and 417 (83%) were women; 395 (79%) completed follow-up. No statistically significant difference in the PRWE score was seen at 12 months (cast group (n=200), mean 21.2 (SD 23.1); K-wire group (n=195), mean 20.7 (22.3); adjusted mean difference -0.34 (95% confidence interval -4.33 to 3.66), P=0.87). No difference was seen at earlier time points. In the cast group, 33 (13%) of participants needed surgical fixation for loss of fracture position in the first six weeks compared with one revision surgery in the K-wire group (odds ratio 0.02, 95% confidence interval 0.001 to 0.10).ConclusionsAmong patients with a dorsally displaced distal radius fracture that needed manipulation, surgical fixation with K-wires did not improve patients' wrist function at 12 months compared with a cast.Trial registrationISRCTN registry ISRCTN11980540.