Comparison of Different Tourniquet Release Times in Bunion Surgery
Evaluation of Post-operative Swelling and Functional Outcomes in Relation to Pneumatic Tourniquet Use Pattern in Bunion Surgery
1 other identifier
interventional
80
1 country
1
Brief Summary
Patients listed for hallux valgus/hallux rigidus correction surgery will be randomised to one of two treatment groups. Group 1 (standard care) will have the calf tourniquet released after wound closure. Group 2 will have the tourniquet removed five minutes before wound closure. Participants will have the volume of their operated foot measured pre-operatively and post-operatively at six weeks and three months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2018
CompletedFirst Posted
Study publicly available on registry
August 6, 2018
CompletedStudy Start
First participant enrolled
August 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2021
CompletedMay 24, 2019
May 1, 2019
3 years
July 25, 2018
May 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Foot volume
The volume of the operated foot measured by water displacement (in millilitres).
3 months post-operatively
Secondary Outcomes (3)
MOxFQ score
3 months post-operatively
Foot pain assessed using a dolometer
3 months post-operatively
Return to work
3 months post-operatively
Study Arms (2)
Standard care
EXPERIMENTALParticipants will have hallux valgus/hallux rigidus surgery using a calf tourniquet which will remain inflated until the wound is closed.
Tourniquet release
EXPERIMENTALParticipants will have hallux valgus/hallux rigidus surgery using a calf tourniquet which will be removed. There will be a five minute delay before the wound is closed.
Interventions
Hallux valgus/hallux rigidus surgery with the calf tourniquet remaining in situ until the wound is closed.
Hallux valgus/hallux rigidus surgery with the calf tourniquet released five minutes before the wound is closed.
Eligibility Criteria
You may qualify if:
- Patients having hallux valgus or hallux rigidus
- Able to give informed consent
- Able to return for follow-up
You may not qualify if:
- Patients with symptomatic peripheral vascular disease
- Patients with known peripheral oedema from any cause
- Patients who will also require lesser toe correction as part of the procedure
- Active smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Golden Jubilee National Hospital
Clydebank, West Dunbartonshire, G81 4DY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kalpesh Shah, M.D.
Gloden Jubilee National Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Those collecting and analysis the data will be masked to the treatment groups. It is not possible to mask the participant or the care provider in this study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2018
First Posted
August 6, 2018
Study Start
August 23, 2018
Primary Completion
August 26, 2021
Study Completion
November 25, 2021
Last Updated
May 24, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share
No data will be shared