Do we have to keep patients in a cast and prevent them from weight bearing after surgical repair of ankle fractures?
| ISRCTN | ISRCTN76410775 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76410775 |
| Secondary identifying numbers | 14-11-2018 |
- Submission date
- 20/05/2019
- Registration date
- 30/06/2019
- Last edited
- 05/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Ankle fractures are common; usually occurring as a result of low energy torsional trauma. Generally, the treatment is either with surgical fixation or non-surgically in the form of immobilization with modified weight bearing depending on the stability of fracture and its pattern. Currently, there is a lack of consensus in post-operative management regimes in terms of the degree of mobilisation and weight bearing allowed following surgical fixation of unstable fractures about the ankle leading to a wide variation in clinical practice. There is an evolving understanding that extended periods of immobilisation and limitation of weight bearing lead to poorer outcomes.
The purpose of this study is to investigate the safety and efficacy of early weight bearing and range of motion exercise regimes after surgical fixation of unstable ankle fractures with a particular focus on functional outcomes and complication rates with an emphasis on those attributable to early weight bearing such as wound compromise and loss of fixation.
Who can participate?
All adult patients with an ankle fracture that need surgical intervention.
What does the study involve?
The proposed method of the study is to compare two groups of patient who will undergo different post-operative management programs: the control arm will be treated using a traditional process of extended immobilization in cast and limitation of weight bearing with the treatment arm being managed, after surgery, in a functional brace (walking boot) with a rehabilitation regime allowing for early exercises and weight bearing.
What are the possible benefits and risks of participating?
The researchers can’t guarantee a benefit to patients who take part in this study. The results of the study may benefit future patients with similar fractures. Taking part in the study will not change the standard of care participants receive. Both modes of treatment are already routinely done in the HSE.
Where is the study run from?
In the University hospital Waterford and two other centres in Ireland awaiting final confirmation and ethical approval.
When is the study starting and how long is it expected to run for?
The study started on 07/01/2019 and expected to run until 07/07/2020
Who is funding the study?
Investigator-initiated and funded
Who is the main contact?
Mr Ramy Khojaly, Orthopaedic Department, University Hospital Waterford, Waterford Ireland
wrh.ortho08@hse.ie
Contact information
Scientific
University Hospital Waterford
Dunmore Road
Waterford
X91 CP5W
Ireland
 ORCID ID |
0000-0002-2286-4745 |
|---|---|
| Phone | +353 51 848 000 |
| r.e.e.khojaly@smd18.qmul.ac.uk |
Study information
| Study design | Multicentre, prospective, randomised controlled trial (RCT), un-blind with participants allocated in a 1:1 ratio to one of two parallel groups. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Is post-operative non-weight-bearing necessary? A pragmatic randomised multicentre trial of operatively treated ankle fracture (DoWeCAST?) |
| Study acronym | DoWeCAST? |
| Study hypothesis | Extended periods of immobilisation and limitation of weight bearing after ankle fracture fixation is unnecessary and leads to poorer outcomes. |
| Ethics approval(s) | 1. Approved 14/11/2018, Research Ethics Committee Health Service Executive, South Eastern Area (Old school of nursing, University Hospital Waterford; +353 51 842026; Caroline.Lamb2@hse.ie) 2. Approved 29/10/2019, Clincial Research Ethics Committee of the Cork Teaching Hospitals (Cork University Hospital, Wilton, Cork, Ireland; +353 21 4901901; crec@ucc.ie), ref: ECM 4 (z) 3. Approved Galway University Hospitals CREC (University Hospital Galway Newcastle Rd, Galway, H91 YR71, Ireland; no tel. provided; no email provieded), ref: C.A.2248 |
| Condition | Unstable ankle fractures |
| Intervention | Consent: All patients admitted to the hospital with ankle fracture requiring surgical intervention get consented by the admitting NCHD for the ankle trail after providing appropriate information and patient information leaflet. Most of the patients get consented the night before surgery; some patients get consented in the day of surgery (day cases). Patient’s selection: The selection process starts in the morning of surgery at the trauma meeting, the operating surgeon and one of the investigators review the patients x-rays and ensure patients are meeting the inclusion criteria, this process continues intra-operatively to ensure achievement of surgical anatomical reduction and stable internal fixation of ankle fracture. Randomisation process: Computer-generated block randomisation (20 patients per block) has been created at the start of the trial. Theatre nurses check the randomisation sequence by accessing the trial excel sheet and inform the surgeon with the appropriate sequence at the end of surgery and insert patients data to the sheet. Treatment: Patients will either get a cast or a walking boot in theatre after surgery. All patients get reviewed by a physiotherapist before discharge. Patients in the cast group are instructed to walk non-weight bearing using crutches/frame for a total of six weeks. Patients in the walking boot group are instructed to walk weight bearing as tolerated immediately, they also instructed to remove the walking boot 4 times a day at minimum and perform ankle range of motion exercises until they referred to outpatient physiotherapy in 2 weeks. All patients receive post-operative instruction sheet. Follow up: Patients are followed up as following; 2 weeks, 6 weeks, 12 weeks, 6 months and 1 year. At each visit, OMAS and SF-36 Health questionnaire are collected from the patient. Attending orthopaedic consultant or NCHD fills up a case report form ( Please find attached) at each visit, this includes the following information; surgical site assessment, x-ray evaluation, ankle ROM (using goniometry), information regarding return to work, confirmation of physiotherapy referral and confirmation of collection of OMAS and SF-36 Health questionnaire. |
| Intervention type | Other |
| Primary outcome measure | Ankle Olerud and Molander Score (OMAS) questionnaire is collected at each visit( 2 weeks, 6 weeks, 12 weeks, 6 months and 1 year). |
| Secondary outcome measures | 1. Ankle range of motion (plantar and dorso-flexion) is measured using goniometry at each follow-up visit. 2. Physical and mental health outcomes SF36 questionnaire are collected at each visit. 3. The time needed to return to work; patients are asked each visit if they returned to work and date of return to work is documented in the case report form. 4. Wound complication and complications related to fracture fixation and bone healing are documented at each visit. |
| Overall study start date | 01/07/2018 |
| Overall study end date | 30/07/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 140 |
| Participant inclusion criteria | All skeletally mature, acute ankle fractures that were treated with anatomical reduction and stable internal fixation including: 1. Isolated lateral malleolus fractures. 2. Isolated medial malleolus fractures. 3. Bi-malleolar fractures. 4.Tri-malleolar fracture. 5. Syndesmosis injuries that has been surgically fixed with either screw or tightrope. 6. Closed, grade I, or grade II open fractures. |
| Participant exclusion criteria | 1. Skeletal immaturity. 2. Grade-III open fractures. 3. Tibial plafond fractures. 4. Polytrauma. 5. Non-ambulatory status before injury. 6. Expected insufficient stable fracture fixation with standard surgical technique. 7. Pre-existent cognitive disability, inability to comply with non-weight-bearing mobilization and inability to comply with follow-up. |
| Recruitment start date | 07/01/2019 |
| Recruitment end date | 07/07/2020 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Waterford
X91ER8E
Ireland
Sponsor information
Hospital/treatment centre
Dunmore Road
waterford
X91 ER8E
Ireland
| Phone | +353 51 848 000 |
|---|---|
| hselive@hse.ie | |
"ROR" |
https://ror.org/007pvy114 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The Result of this trial will be published in a medical journal at the end of the trail. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/05/2021 | 01/06/2021 | Yes | No |
Editorial Notes
05/08/2021: The following changes have been made:
1. The overall trial end date has been changed from 07/07/2021 to 30/07/2021.
2. The study contact has been updated.
01/06/2021: Publication reference added.
14/04/2020: Due to the public health situation and to minimise exposing patients to a hospital environment for their safety all unnecessary appointments are cancelled for now. The trial team will continue collecting as much data as possible remotely, via virtual fracture clinic, online and using post services.
06/02/2020: The following changes were made to the trial record:
1. The scientific title was changed from "Do we have to keep patients in cast and prevent them weight bearing after Open reduction and internal fixation (ORIF) of unstable ankle fractures? A multicentre randomised controlled trial" to "Is post-operative non-weight-bearing necessary? A pragmatic randomised multicentre trial of operatively treated ankle fracture (DoWeCAST?)".
2. The total target enrolment was changed from 100 to 140.
08/01/2020: The ethics approvals (2, 3) were added.
21/05/2019: Trial's existence confirmed by the Research Ethics Committee Health Service Executive, South Eastern Area.
