Hallux ValgusNCT03616847
Comparison of Different Tourniquet Release Times in Bunion Surgery
A study testing Tourniquet release in people with Hallux Valgus and Hallux Rigidus, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus, Hallux Rigidus
- What is being tested?
- Tourniquet release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Aug 2018to 25 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having hallux valgus or hallux rigidus
- Able to give informed consent
- Able to return for follow-up
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Golden Jubilee National Hospital
Clydebank, West Dunbartonshire, G81 4DY
Alistair M Ewen, PhD, 0141 951 5946, alistair.ewen@gjnh.scot.nhs.uk
Kathryn Macpherson, BSc, 0141 951 5121, kathryn.macpherson@gjnh.scot.nhs.uk
About this study
Official title: Evaluation of Post-operative Swelling and Functional Outcomes in Relation to Pneumatic Tourniquet Use Pattern in Bunion Surgery
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.
Read the 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.
- Conditions
- Hallux Valgus, Hallux Rigidus
- Being tested
- Standard care, Tourniquet release
- Keywords
- Randomised controlled trial, Hallux valgus correction, Hallux rigidus correction, Tourniquet, Foot volume
- Medical subject headings
- Hallux Valgus, Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Hallux valgus/hallux rigidus surgery with the calf tourniquet remaining in situ until the wound is closed.
Tourniquet releaseOther
Hallux valgus/hallux rigidus surgery with the calf tourniquet released five minutes before the wound is closed.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Experimental | Participants will have hallux valgus/hallux rigidus surgery using a calf tourniquet which will remain inflated until the wound is closed. Receives: Other: Standard care |
| Tourniquet release | Experimental | 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. Receives: Other: Tourniquet release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot volume
The volume of the operated foot measured by water displacement (in millilitres).
Measured: 3 months post-operatively
Secondary outcomes (3)
MOxFQ score
Manchester-Oxford Foot Questionnaire score (0-100, 100 being the most severe)
Measured: 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).
Measured: 3 months post-operatively
Return to work
Time after surgery the participant returned to work (reported in weeks since surgery)
Measured: 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start23 Aug 2018
- Primary completion26 Aug 2021 (estimated)
- Study completion25 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two randomised study groups with one having standard care and the other the intervention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kalpesh Shah, M.D., Principal investigator, Gloden Jubilee National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616847
- Sponsor's protocol ID
- 18/ORTH/03
- Status last verified
- May 2019
- First submitted
- 25 Jul 2018
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-operative Swelling and Functional Outcomes in Relation to Pneumatic Tourniquet Use Pattern in Bunion Surgery
- ClinicalTrials.gov ID
- NCT03616847
- Acronym / sponsor ID
- 18/ORTH/03
- Conditions
- Hallux Valgus, Hallux Rigidus
- Keywords
- Randomised controlled trial, Hallux valgus correction, Hallux rigidus correction, Tourniquet, Foot volume
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 26 Aug 2021 (estimated)
- Study completion
- 25 Nov 2021 (estimated)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two randomised study groups with one having standard care and the other the intervention.
| Arm | Type | Receives |
|---|---|---|
| Standard care | Experimental | Other: Standard careParticipants will have hallux valgus/hallux rigidus surgery using a calf tourniquet which will remain inflated until the wound is closed. |
| Tourniquet release | Experimental | Other: Tourniquet releaseParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients having hallux valgus or hallux rigidus
- Able to give informed consent
- Able to return for follow-up
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard careHallux valgus/hallux rigidus surgery with the calf tourniquet remaining in situ until the wound is closed. | Other | Standard care |
| Tourniquet releaseHallux valgus/hallux rigidus surgery with the calf tourniquet released five minutes before the wound is closed. | Other | Tourniquet release |
Primary outcome
Foot volume
Time frame: 3 months post-operatively
The volume of the operated foot measured by water displacement (in millilitres).
3 secondary outcomes
MOxFQ score
Time frame: 3 months post-operatively
Foot pain assessed using a dolometer
Time frame: 3 months post-operatively
Return to work
Time frame: 3 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Individual participant dataSharing planned: No. No data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kalpesh Shah, M.D. principal investigator
Gloden Jubilee National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet release in people with Hallux Valgus and Hallux Rigidus, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alistair M Ewen, Ph. D. (0141 951 5946, alistair.ewen@gjnh.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot volume (time frame: 3 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.