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Comparison of Different Tourniquet Release Times in Bunion Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616847
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Golden Jubilee National Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : August 23, 2018
Estimated Primary Completion Date : August 26, 2021
Estimated Study Completion Date : November 25, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion
MedlinePlus related topics: Foot Health

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.




Primary Outcome Measures :
  1. Foot volume [ Time Frame: 3 months post-operatively ]
    The volume of the operated foot measured by water displacement (in millilitres).


Secondary Outcome Measures :
  1. MOxFQ score [ Time Frame: 3 months post-operatively ]
    Manchester-Oxford Foot Questionnaire score (0-100, 100 being the most severe)

  2. 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).

  3. Return to work [ Time Frame: 3 months post-operatively ]
    Time after surgery the participant returned to work (reported in weeks since surgery)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients having hallux valgus or hallux rigidus
  • Able to give informed consent
  • Able to return for follow-up

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Alistair M Ewen, Ph. D. 0141 951 5946 alistair.ewen@gjnh.scot.nhs.uk
Contact: Kathryn Macpherson, B. Sc. 0141 951 5121 kathryn.macpherson@gjnh.scot.nhs.uk

Locations
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United Kingdom
Golden Jubilee National Hospital Recruiting
Clydebank, West Dunbartonshire, United Kingdom, G81 4DY
Contact: Alistair M Ewen, PhD    0141 951 5946    alistair.ewen@gjnh.scot.nhs.uk   
Contact: Kathryn Macpherson, BSc    0141 951 5121    kathryn.macpherson@gjnh.scot.nhs.uk   
Principal Investigator: Kalpesh Shah, M.D         
Sponsors and Collaborators
Golden Jubilee National Hospital
Investigators
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Principal Investigator: Kalpesh Shah, M.D. Gloden Jubilee National Hospital
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Responsible Party: Golden Jubilee National Hospital
ClinicalTrials.gov Identifier: NCT03616847    
Other Study ID Numbers: 18/ORTH/03
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Golden Jubilee National Hospital:
Randomised controlled trial
Hallux valgus correction
Hallux rigidus correction
Tourniquet
Foot volume
Additional relevant MeSH terms:
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Hallux Valgus
Hallux Rigidus
Hallux Limitus
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired
Joint Diseases
Foot Injuries
Leg Injuries
Wounds and Injuries