An interventional study of Standard care and Tourniquet release in Hallux Valgus and Hallux Rigidus, sponsored by Golden Jubilee National Hospital. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-24.
Sponsored by Golden Jubilee National Hospital · Not applicable, Interventional, and Treatment
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.
Pneumatic tourniquets provide the benefits of better visualisation and decreased blood loss, but can also cause metabolic changes due to ischemia and compressive damage due to pressure. Surveys of foot and ankle surgeons demonstrates prevalent use of tourniquets in their clinical practice, with various patterns of use differing amongst the surgeons.
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.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 80 is above the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Golden Jubilee National Hospital is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will have hallux valgus/hallux rigidus surgery using a calf tourniquet which will remain inflated until the wound is closed.
Other: Standard care
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.
Other: Tourniquet release
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.
Foot volume
The volume of the operated foot measured by water displacement (in millilitres).
Time frame: 3 months post-operatively
MOxFQ score
Manchester-Oxford Foot Questionnaire score (0-100, 100 being the most severe)
Time frame: 3 months post-operatively
Foot pain assessed using a dolometer
Foot pain measured on a visual analogue scale (0-10, 0 being no pain \& 10 being worst pain imaginable).
Time frame: 3 months post-operatively
Return to work
Time after surgery the participant returned to work (reported in weeks since surgery)
Time frame: 3 months post-operatively
Plan to share: No — No data will be shared
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Golden Jubilee National Hospital