Hallux Valgus Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04473196 -
The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
|
N/A | |
Recruiting |
NCT05587569 -
Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
|
N/A | |
Recruiting |
NCT05555459 -
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
|
N/A | |
Completed |
NCT02121119 -
Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump
|
Phase 4 | |
Enrolling by invitation |
NCT00600899 -
Home Infusors for Analgesia After Foot Surgery
|
Phase 4 | |
Completed |
NCT05579054 -
Translation, Validity, and Reliability of the Foot Posture Index (FPI-6) - Turkish Version
|
||
Terminated |
NCT05082012 -
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
|
N/A | |
Recruiting |
NCT05051709 -
Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus
|
N/A | |
Recruiting |
NCT04716140 -
Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery
|
N/A | |
Active, not recruiting |
NCT04145882 -
Efficacy of Additional Osteotomies to Correct Hallux Valgus
|
N/A | |
Completed |
NCT04468555 -
Hallux Valgus Manual Therapy Based on Global Postural Reeducation.
|
N/A | |
Terminated |
NCT03257540 -
Early Weight-Bearing After Lapidus Arthrodesis
|
||
Completed |
NCT03846687 -
Validation of Patient Reported Outcome Measures for Use in Hallux Valgus
|
||
Completed |
NCT04365712 -
Osteotomy of the 1st Metatarsal for Hallux Valgus Using Pneumatic Oscillating Saw or Piezoelectric Scalpel
|
N/A | |
Recruiting |
NCT02282956 -
Ultrasound Guided Single Shot Block of Posterior Tibial Nerve for Postoperative Pain Relief After Hallux Valgus Surgery
|
Phase 4 | |
Withdrawn |
NCT01555216 -
Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block
|
N/A | |
Completed |
NCT00683137 -
Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery
|
Phase 3 | |
Terminated |
NCT04103814 -
Effect of Topical CBD Cream for Degenerative Hallux Disorders
|
Phase 2/Phase 3 | |
Completed |
NCT03423498 -
The Toe-spread-out Exercise in Patients With Hallux Valgus and Without the Deformity
|
N/A | |
Not yet recruiting |
NCT06076655 -
Hallux Valgus Treatment Developed for Children With Cerebral Palsy
|
N/A |