Comparison of Different Tourniquet Release Times in Bunion Surgery

Sponsor

Golden Jubilee National Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03616847

Collaborator

(none)

Enrollment

Location

Arms

39.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hallux Valgus Hallux Rigidus	Other: Standard care Other: Tourniquet release	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two randomised study groups with one having standard care and the other the intervention.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

Primary Purpose:

Treatment

Official Title:

Evaluation of Post-operative Swelling and Functional Outcomes in Relation to Pneumatic Tourniquet Use Pattern in Bunion Surgery

Actual Study Start Date :

Aug 23, 2018

Anticipated Primary Completion Date :

Aug 26, 2021

Anticipated Study Completion Date :

Nov 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Foot volume [3 months post-operatively]
The volume of the operated foot measured by water displacement (in millilitres).

Secondary Outcome Measures

MOxFQ score [3 months post-operatively]
Manchester-Oxford Foot Questionnaire score (0-100, 100 being the most severe)
Foot pain assessed using a dolometer [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 [3 months post-operatively]
Time after surgery the participant returned to work (reported in weeks since surgery)