Fusion surgery for bunions gives improvement in pain and function
| ISRCTN | ISRCTN99306723 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99306723 |
- Submission date
- 29/01/2025
- Registration date
- 28/04/2025
- Last edited
- 28/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims:
Hallux valgus (HV) is a painful deformity of the big toe/forefoot, also known as a bunion. There are multiple surgical options for its management, including fusing the joint at the base of the big toe (first metatarsophalangeal joint [MTPJ] arthrodesis). In our institution, this procedure is preferred over corrective osteotomy for patients with severe HV. This study aimed to investigate the outcomes of patients undergoing first MTPJ arthrodesis for HV.
Who can participate?
Patients aged over 16 years undergoing arthrodesis for HV between 2016 and 2021 in NHS Tayside
What does the study involve?
Participants complete questionnaires about their health and function before surgery and at 26, 52 and 104 weeks after surgery.
What are the possible benefits and risks of participating?
The study will identify whether first metatarsophalangeal joint fusion is a safe and effective treatment for hallux valgus.
Where is the study run from?
NHS Tayside (UK)
When is the study starting and how long is it expected to run for?
January 2021 to June 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Miss Rebecca Lewis, rebecca.lewis@nhs.scot
Contact information
Public, Scientific, Principal Investigator
Department of Trauma & Orthopaedics
NHS Tayside
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
 ORCID ID |
0000-0002-9854-8570 |
|---|---|
| Phone | +44 (0)1382 660111 |
| rebecca.lewis@nhs.scot |
Study information
| Study design | Single-centre observational case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment, Efficacy |
| Scientific title | First metatarsophalangeal joint arthrodesis for hallux valgus gives satisfactory patient-reported outcomes: a retrospective case series |
| Study objectives | Arthrodesis for hallux valgus in the absence of radiological evidence of degenerative joint disease results in improvements in patient-reported outcome measures. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | Ethical approval was not sought for this study because it was a retrospective evaluation of local clinical practice and, therefore, not deemed to require ethics committee approval. Caldicott permission was sought and granted. |
| Health condition(s) or problem(s) studied | Hallux valgus |
| Intervention | The researchers will conduct a single-centre case series design with prospectively collected Patient Reported Outcome Measures data and retrospective case note review. Data will be requested from the local Foot and Ankle database. For each patient, the primary pathology of HV will be confirmed using preoperative radiographs and first MTPJ arthrodesis will be confirmed using the operative notes. After confirming these details, all patients who have completed preoperative PROMs and had their operations between January 2016 and July 2021 will be included. Patients will be excluded based on inadequate operative information, in cases where arthrodesis cannot be confirmed, and patients whose primary pathology is degenerative disease, apparent on preoperative radiographs. Some patients will have undergone simultaneous bilateral arthrodesis or additional concurrent procedures involving the first ray or lesser metatarsals; to reflect clinical practice, these patients will be included. Finally, patients will not be excluded because of rheumatoid arthritis if HV is still considered the primary pathology. Instead, patients with rheumatoid and diabetes mellitus will be considered during analysis. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Pain is measured using the Manchester-Oxford foot questionnaire (MOxFQ) and the EQ-5D-5L questionnaire at baseline, 26, 52 and 104 weeks postoperatively 2. Walking-standing ability is measured using the Manchester-Oxford foot questionnaire (MOxFQ) at baseline, 26, 52 and 104 weeks postoperatively 3. Social interaction is measured using the Manchester-Oxford foot questionnaire (MOxFQ) at baseline, 26, 52 and 104 weeks postoperatively 4. Overall health is measured using the EQ-5D-5L visual analogue score (VAS) at baseline, 26, 52 and 104 weeks postoperatively |
| Secondary outcome measures | Complication rates, including non-union, pain, reoperation, infection and delayed wound healing. This data will be collected at the end of the study period. |
| Overall study start date | 01/01/2021 |
| Completion date | 30/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 62 |
| Key inclusion criteria | 1. Aged over 16 years 2. Undergone first MTPJ arthrodesis for hallux valgus between January 2016 and July 2021 |
| Key exclusion criteria | Patients with inadequate operative information. |
| Date of first enrolment | 22/01/2016 |
| Date of final enrolment | 10/06/2021 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Dundee
DD3 8EA
United Kingdom
Sponsor information
Hospital/treatment centre
Ninewells Hospital
Dundee
DD1 9SY
Scotland
United Kingdom
| Website | http://www.nhstayside.scot.nhs.uk/index.htm |
|---|---|
"ROR" |
https://ror.org/000ywep40 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to data protection & patient confidentiality. |
Editorial Notes
29/01/2025: Study's existence confirmed by the University of Dundee.
