Comparison of Different Tourniquet Release Times in Bunion Surgery
NCT ID: NCT03616847
Last Updated: 2019-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
80 participants
INTERVENTIONAL
2018-08-23
2021-11-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tourniquet Use in Hallux Valgus Surgery
NCT06680518
Prospective and Comparative Analysis of Arthroscopic and Open Surgery for Hallux Rigidus
NCT00284362
Transarticular Lateral Release Versus Percutaneous Lateral Release for Hallux Valgus
NCT04614675
Operative Versus Non-operative Treatment for Mild to Moderate Hallux Valgus Deformity
NCT06114043
Early Weight Bearing Tarsometatarsal Fusion Study
NCT03812237
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Bunion surgery is one of the most common surgical procedures in foot surgery. It involves correcting the hallux valgus deformity through a combination of various osteotomy, fusion, or soft tissue procedures. Swelling after any surgery is common, but particularly so after foot surgery as gravity causes fluid to collect in the foot. With regards to recovery after surgery, patients are advised to expect to be off work for between 6-8 weeks for a sedentary occupation, and between 12-14 weeks for heavy work. Although patients have low pain levels, the foot remains swollen for an average of 3-6 months after surgery. It is usually the swelling that prevents patients from getting in to normal footwear to be able to return to work sooner.
Bunion surgery is usually performed under a calf-tourniquet to create a bloodless surgical field and ensure less surgical bleeding, thereby reducing surgical time. However, use of tourniquets can lead to more swelling, increased post-operative pain and challenges in rehabilitation - all of which may affect recovery after bunion surgery. Prolonged duration of tourniquet use has been shown to cause post-operative wound healing complications, potentially attributable to local inflammation and tissue hypoxia. It is known from the studies for knee replacement surgery that tourniquet use can lead to decreased range of motion after surgery in early stage.
This study will be a randomised controlled trial with two study groups. The control group will have surgery with the tourniquet remaining in situ until the wound is closed. The intervention group will have the tourniquet released after surgery, but closure will be delayed by five minutes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard care
Participants will have hallux valgus/hallux rigidus surgery using a calf tourniquet which will remain inflated until the wound is closed.
Standard care
Hallux valgus/hallux rigidus surgery with the calf tourniquet remaining in situ until the wound is closed.
Tourniquet release
Participants 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.
Tourniquet release
Hallux valgus/hallux rigidus surgery with the calf tourniquet released five minutes before the wound is closed.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard care
Hallux valgus/hallux rigidus surgery with the calf tourniquet remaining in situ until the wound is closed.
Tourniquet release
Hallux valgus/hallux rigidus surgery with the calf tourniquet released five minutes before the wound is closed.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to give informed consent
* Able to return for follow-up
Exclusion Criteria
* Patients with known peripheral oedema from any cause
* Patients who will also require lesser toe correction as part of the procedure
* Active smokers
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Golden Jubilee National Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kalpesh Shah, M.D.
Role: PRINCIPAL_INVESTIGATOR
Gloden Jubilee National Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Golden Jubilee National Hospital
Clydebank, West Dunbartonshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18/ORTH/03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.