Comparing surgical fixation and conservative management using a cast in wrist fractures in people aged 65 years and older
| ISRCTN | ISRCTN95922938 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95922938 |
| IRAS number | 283764 |
| Secondary identifying numbers | IRAS 283764 |
- Submission date
- 02/12/2021
- Registration date
- 03/12/2021
- Last edited
- 24/10/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Fractures of the radius bone in the lower arm near to the wrist are the most common fracture, accounting for 16% of all fractures. They are commonest in elderly patients after falls. At the Royal Infirmary of Edinburgh alone, we see over 1000 of these fractures each year. When the bony fragments displace (move) out of position the current best treatment is surgical fixation. In our centre, this is most commonly achieved by fixing the bone fragments with a metal plate and screws inserted from the volar (front) side of the wrist. While this makes for better bone position, its effect on function in elderly patients is unclear. There is no general agreement for about the best way to manage wrist fractures in elderly people and practice varies widely.
Some previous research showed no clear benefit of surgery over a cast in terms of patient-reported outcomes (the results that are considered most important to patients) in the elderly. The current randomised controlled trials (RCTs) in the scientific literature have limitations and demonstrate mixed results, with some showing that surgical fixation results in better outcomes whilst others suggest that there is no difference. Recent literature reviews combining the results of many research studies found that, although the surgery group had slightly improved function, it might not be worth the risks involved in surgery. We want to carry out an RCT to compare functional outcomes of non-surgical management and surgical fixation of displaced distal radius fractures (a type of wrist fracture) in patients aged 65 years and older. If it is shown that a cast is just as good as surgery, this could save thousands of unnecessary operations each year both in the UK and abroad.
Who can participate?
All patients aged 65 years and older presenting to the Edinburgh Orthopaedic Trauma Service with the correct type of broken wrist (distal radius fracture) will be invited to participate in the study. We intend to recruit 184 patients.
What does the study involve?
Patients who take part in this study will receive treatment either with a cast or with an operation. Which technique they receive is entirely decided by random allocation and will be decided immediately on agreeing to take part. All other aspects of care will be identical to the care received out with the study.
Patients can take as long as they need to decide whether to take part, but they are only eligible to take part for the first 3 weeks after their fracture and we usually aim not to delay any treatment. One of the orthopaedic doctors who is familiar with the study and the treatments will discuss the study with the patient, answer any questions and go through a study consent form with them, asking them to sign this if they agree to take part. Patients will then be randomly allocated to either surgery or cast treatment. Those patients for surgery will be listed for surgery on our routine trauma list. This is usually done as a day case within a few days but can take up to 1 to 2 weeks (in other words patients can go home and come back for surgery as long as they will be safe at home in the meantime). COVID-19 has changed the way that patients are cared for in many ways. Depending on the guidelines at the time, patients may need to self-isolate and then undergo a test for COVID-19 before they come in for an operation. Patients for cast management will have follow-up arranged in the outpatient clinic to ensure their cast is in adequate condition.
After treatment, we intend to follow up all participants for 1 year. This involves three routine visits to the Royal Infirmary of Edinburgh at 2 weeks, 6 weeks and 12 weeks, with questionnaires via the post or over the phone at 6 months and 1 year following surgery. At follow-up clinic visits, which are required whether or not patients are part of the study, patients will be reviewed by a doctor from the orthopaedic team. They will be asked some simple questions about their progress, as well as take a short series of wrist and hand movement and strength tests. Patients will be asked to complete questionnaires regarding their level of wrist function and will be asked to undergo 2 wrist x-rays. The whole process should take approximately 60 minutes at each visit. Patients may be seen by a member of the physiotherapy team if they are felt to require this. The questionnaires that will be sent at 6 months and 1 year after injury are part of the study and not part of standard clinical care.
We will also review patient records to see whether you need any further wrist operations within 2 years. This will not require any further outpatient appointments.
What are the possible risks and benefits of participating?
There are no direct benefits of taking part. However, the information we get from this study should help improve the treatment of people who suffer your type of injury in the future.
There are risks involved with each of the treatment options. Overall, we do not currently know which option is better – hence the need for this study.
Conservative treatment in a cast: In the short term, this is very simple and has very few complications associated with it. It is possible that patient's longer-term outcome will be as good as with surgery, but this may not be the case. It may be that patients end up with stiffness and/or pain in the wrist. In the rare occasion this happens, then there is the option for an operation later to re-break the bone and straighten it. This operation is usually successful, although most patients do complain of some degree of ongoing stiffness and discomfort afterwards.
Surgical management with an operation: The risks of this treatment include bleeding, infection, nerve injury, prominent metal that requires removal, ongoing pain/ stiffness, along with rare complications associated with anaesthesia and surgery.
Patients who take part in this study will have x-rays (and potentially x-ray guided surgery) of the wrist. Up to one of these x-rays will be additional to those that they would have if they did not take part. These procedures use ionising radiation to form images of the body and provide the doctor with other clinical information. Ionising radiation can cause cell damage that may, after many years or decades, turn cancerous. We are all at risk of developing cancer during our lifetime. Taking part in this study will add only a very small chance of this happening.
Where is the study run from?
TheRoyal Infirmary of Edinburgh (UK)
When is the study starting and how long is it expected to run for?
October 2019 to December 2025
Who is funding the study?
The Scottish Orthopaedic Research Trust Into Trauma (SORT-IT) (UK) and the Orthopaedic Trauma Association (OTA) (USA)
Who is the main contact?
1. Mr Andrew Duckworth (scientific contact), andrew.duckworth@ed.ac.uk
2. Miss Katrina Bell (public contact), katrina.bell@nhslothian.scot.nhs.uk
Contact information
Public
Department of Trauma and Orthopaedic Surgery
Royal Infirmary of Edinburgh
51 Little France Crescent
Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom
 ORCID ID |
0000-0003-4145-4909 |
|---|---|
| Phone | +44 (0)131 242 3545 |
| katrina.bell@nhslothian.scot.nhs.uk |
Scientific
Centre for Population Health Sciences
Usher Institute @ Bioquarter
NINE
9 Little France Road
Edinburgh
EH16 4UX
United Kingdom
| ORCID ID |
0000-0002-5317-1300 |
|---|---|
| Phone | +44 (0)131 242 3484 |
| andrew.duckworth@ed.ac.uk |
Study information
| Study design | Single-centre interventional randomized controlled trial |
|---|---|
| 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 | Elderly - Fixation Of the Radius: Radiological and Clinical Evaluation (eFORRCE): A prospective randomised superiority trial of surgical versus conservative management for unstable fractures of the distal radius in patients aged 65 and older. |
| Study acronym | eFORRCE |
| Study hypothesis | The Patient-Rated Wrist Evaluation (PRWE) score with surgical fixation is superior to that with conservative management at 1 year. |
| Ethics approval(s) | Approved 23/09/2021, Scotland B Research Ethics Committee (2nd Floor Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44 (0)131 465 5680; manx.neill@nhslothian.scot.nhs.uk), ref: 21/SS/0061 |
| Condition | Unstable fractures of the distal radius in patients aged 65 years and older |
| Intervention | Surgical patients will be treated routinely with standard volar plate techniques as per routine trauma care. Following surgery, the post-operative assessment and course will be as per normal protocol for patients who are not in this study. Physiotherapy will be arranged as required at the discretion of the treating surgeon. Non-operatively managed patients will receive 6 weeks in cast and then be referred to physiotherapy at the discretion of the treating surgeon. The cast will be in the form of a below-elbow Plaster of Paris Colles backslab (a type of plaster cast used to treat distal radius fractures) for the first week following injury. This will be completed with synthetic cast material after one week and then changed to a circumferential below-elbow Colles synthetic cast at 2 weeks post-injury until 6weeks post-injury. Participants will be randomised to receive surgical or conservative management on a 1:1 ratio. An independent statistician employed through the University of Edinburgh research methodology department will produce a computer-generated randomisation schedule using a block randomisation with a random block size. Randomisation will be stratified based on the fracture AO classification to ensure as far as possible that there are equal numbers of type A and C fractures in each treatment arm. Classification of fracture type will be carried out by one of the consultants involved in the study. In 2010-2011, there were 505 distal radius fractures in patients aged ≥65 years, of which 351 were type A, 111 were type C and the remaining fractures were of a type that would not be eligible for study inclusion. It is therefore expected to be 76% type A and 24% type C. Two separate randomisation lists will be produced, one for type A fractures and a second for type C fractures. A member of staff independent from the trial will use this list to create opaque sequentially sealed envelopes for each list containing a participant identification number and the treatment allocation. To aid identification and ensure that the next randomisation envelope is taken from the appropriate list, the fracture type (A or C) will be stated on the front of the envelopes with differently coloured stickers for each arm. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Wrist pain and disability assessed using the Patient-Rated Wrist Evaluation (PRWE) at 1 year (52 weeks) post-injury |
| Secondary outcome measures | 1. Wrist pain and disability assessed using the Patient-Rated Wrist Evaluation (PRWE) at 12 and 26 weeks 2. Health-related quality of life measured using EuroQol 3 Dimensions (3L) Score (EQ-5D-3L) at 12 weeks, 26 weeks and 52 weeks 3. Physical function of the upper limb measured using the Quick Disabilities of the Arm Shoulder and Hand (QuickDASH) score at 12 weeks, 26 weeks and 52 weeks 4. Pain assessed by VAS pain score at 2 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks 5. Healthcare resource use, and comparative cost-effectiveness at 1 year (52 weeks) using data collected from patient interviews and questionnaire responses and appropriate statistical and economic analysis methods 6. Complication rate obtained by patient questionnaire responses and reviewing patient notes at 1 year (52 weeks) 7. Grip strength assessed using a dynamometer at 12 weeks 8. Wrist range of motion assessed using a goniometer at 12 weeks 9. Radiographic parameters (including radial inclination, radial height, ulnar variance, carpal malalignment, dorsal tilt, intra-articular step and intra-articular gap) assessed using X-ray imaging at 2 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks |
| Overall study start date | 21/10/2019 |
| Overall study end date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 178 |
| Participant inclusion criteria | 1. Aged ≥65 years 2. Dorsally angulated fractures of the distal radius 3. The treating surgeon believes the patient is suitable for surgical fixation 4. Operation date within 3 weeks of fracture 5. Closed or Gustilo-Anderson grade I injury |
| Participant exclusion criteria | 1. Patients unable to give informed consent 2. Patients medically unfit to undergo surgery 3. Volar displaced fractures 4. Partial articular and isolated radial styloid fractures 5. Associated fractures to the upper limb and/or pre-existing pathology adversely affecting function 6. Associated ligamentous injury, dislocation or subluxation of the wrist 7. Open fractures of Gustilo-Anderson grade II or higher 8. Persisting neurovascular deficit requiring operative intervention 9. Off-ended/severely displaced fractures post attempted reduction that are deemed to require surgery by the treating surgeon 10. Non-residents who will be unable to attend for local follow-up 11. Patients unable to comply with follow-up, including English-language patient-reported outcome measures, either on the telephone or by post |
| Recruitment start date | 07/02/2022 |
| Recruitment end date | 31/12/2025 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom
Sponsor information
University/education
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 242 3326 |
|---|---|
| resgov@accord.scot | |
| Website | http://www.ed.ac.uk/home |
"ROR" |
https://ror.org/01nrxwf90 |
Hospital/treatment centre
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 242 3325 |
|---|---|
| accord@nhslothian.scot.nhs.uk | |
| Website | http://www.nhslothian.scot.nhs.uk/Pages/default.aspx |
|
"ROR" |
https://ror.org/03q82t418 |
Funders
Funder type
Other
Government organisation / Associations and societies (private and public)
- Alternative name(s)
- Orthopaedic Trauma Association, Incorporated, Orthopedic Trauma Association Inc, OTA
- Location
- United States of America
No information available
Results and Publications
| Intention to publish date | 31/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of protocol once study is underway. Planned publication of results in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the study (fully anonymised) will be available upon request after the publication of the study results from Miss Katrina Bell (katrina.bell@nhslothian.scot.nhs.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 21/10/2024 | 24/10/2024 | Yes | No |
Editorial Notes
LH 24/10/2024: Added pub from PubMed alert.
11/03/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2024 to 31/12/2025.
2. The overall end date was changed from 31/12/2025 to 31/12/2026.
3. The intention to publish date was changed from 31/12/2026 to 31/12/2027.
4. The target number of participants was changed from 184 to 178.
03/04/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 03/12/2023 to 31/12/2024.
2. The overall end date was changed from 03/12/2024 to 31/12/2025.
3. The intention to publish date was changed from 03/12/2025 to 31/12/2026.
4. The plain English summary was updated to reflect these changes.
10/02/2022: The recruitment start date was changed from 14/12/2021 to 07/02/2022.
17/12/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 03/12/2021 to 14/12/2021.
2. The data sharing statement was added.
02/12/2021: Trial's existence confirmed by Scotland B Research Ethics Committee.
