Comparison of Different Tourniquet Release Times in Bunion Surgery
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|ClinicalTrials.gov Identifier: NCT03616847|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hallux Valgus Hallux Rigidus||Other: Standard care Other: Tourniquet release||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two randomised study groups with one having standard care and the other the intervention.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||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|
|Official Title:||Evaluation of Post-operative Swelling and Functional Outcomes in Relation to Pneumatic Tourniquet Use Pattern in Bunion Surgery|
|Actual Study Start Date :||August 23, 2018|
|Estimated Primary Completion Date :||August 26, 2021|
|Estimated Study Completion Date :||November 25, 2021|
Experimental: Standard care
Participants will have hallux valgus/hallux rigidus surgery using a calf tourniquet which will remain inflated until the wound is closed.
Other: Standard care
Hallux valgus/hallux rigidus surgery with the calf tourniquet remaining in situ until the wound is closed.
Experimental: 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.
Other: Tourniquet release
Hallux valgus/hallux rigidus surgery with the calf tourniquet released five minutes before the wound is closed.
- Foot volume [ Time Frame: 3 months post-operatively ]The volume of the operated foot measured by water displacement (in millilitres).
- MOxFQ score [ Time Frame: 3 months post-operatively ]Manchester-Oxford Foot Questionnaire score (0-100, 100 being the most severe)
- Foot pain assessed using a dolometer [ Time Frame: 3 months post-operatively ]Foot pain measured on a visual analogue scale (0-10, 0 being no pain & 10 being worst pain imaginable).
- Return to work [ Time Frame: 3 months post-operatively ]Time after surgery the participant returned to work (reported in weeks since surgery)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616847
|Contact: Alistair M Ewen, Ph. D.||0141 951 email@example.com|
|Contact: Kathryn Macpherson, B. Sc.||0141 951 firstname.lastname@example.org|
|Golden Jubilee National Hospital||Recruiting|
|Clydebank, West Dunbartonshire, United Kingdom, G81 4DY|
|Contact: Alistair M Ewen, PhD 0141 951 5946 email@example.com|
|Contact: Kathryn Macpherson, BSc 0141 951 5121 firstname.lastname@example.org|
|Principal Investigator: Kalpesh Shah, M.D|
|Principal Investigator:||Kalpesh Shah, M.D.||Gloden Jubilee National Hospital|