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Comparison of Different Tourniquet Release Times in Bunion Surgery

Primary Purpose

Hallux Valgus, Hallux Rigidus

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Standard care
Tourniquet release
Sponsored by
Golden Jubilee National Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring Randomised controlled trial, Hallux valgus correction, Hallux rigidus correction, Tourniquet, Foot volume

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Golden Jubilee National HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard care

Tourniquet release

Arm Description

Participants will have hallux valgus/hallux rigidus surgery using a calf tourniquet which will remain inflated until the wound is closed.

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.

Outcomes

Primary Outcome Measures

Foot volume
The volume of the operated foot measured by water displacement (in millilitres).

Secondary Outcome Measures

MOxFQ score
Manchester-Oxford Foot Questionnaire score (0-100, 100 being the most severe)
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).
Return to work
Time after surgery the participant returned to work (reported in weeks since surgery)

Full Information

First Posted
July 25, 2018
Last Updated
May 22, 2019
Sponsor
Golden Jubilee National Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03616847
Brief Title
Comparison of Different Tourniquet Release Times in Bunion Surgery
Official Title
Evaluation of Post-operative Swelling and Functional Outcomes in Relation to Pneumatic Tourniquet Use Pattern in Bunion Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
August 26, 2021 (Anticipated)
Study Completion Date
November 25, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Golden Jubilee National Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus, Hallux Rigidus
Keywords
Randomised controlled trial, Hallux valgus correction, Hallux rigidus correction, Tourniquet, Foot volume

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two randomised study groups with one having standard care and the other the intervention.
Masking
InvestigatorOutcomes 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
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
Experimental
Arm Description
Participants will have hallux valgus/hallux rigidus surgery using a calf tourniquet which will remain inflated until the wound is closed.
Arm Title
Tourniquet release
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Hallux valgus/hallux rigidus surgery with the calf tourniquet remaining in situ until the wound is closed.
Intervention Type
Other
Intervention Name(s)
Tourniquet release
Intervention Description
Hallux valgus/hallux rigidus surgery with the calf tourniquet released five minutes before the wound is closed.
Primary Outcome Measure Information:
Title
Foot volume
Description
The volume of the operated foot measured by water displacement (in millilitres).
Time Frame
3 months post-operatively
Secondary Outcome Measure Information:
Title
MOxFQ score
Description
Manchester-Oxford Foot Questionnaire score (0-100, 100 being the most severe)
Time Frame
3 months post-operatively
Title
Foot pain assessed using a dolometer
Description
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
Title
Return to work
Description
Time after surgery the participant returned to work (reported in weeks since surgery)
Time Frame
3 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alistair M Ewen, Ph. D.
Phone
0141 951 5946
Email
alistair.ewen@gjnh.scot.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn Macpherson, B. Sc.
Phone
0141 951 5121
Email
kathryn.macpherson@gjnh.scot.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalpesh Shah, M.D.
Organizational Affiliation
Gloden Jubilee National Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Golden Jubilee National Hospital
City
Clydebank
State/Province
West Dunbartonshire
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alistair M Ewen, PhD
Phone
0141 951 5946
Email
alistair.ewen@gjnh.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Kathryn Macpherson, BSc
Phone
0141 951 5121
Email
kathryn.macpherson@gjnh.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Kalpesh Shah, M.D

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data will be shared

Learn more about this trial

Comparison of Different Tourniquet Release Times in Bunion Surgery

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