The pain relief and complications in metatarsalgia randomised controlled trial
A randomised controlled trial comparing flat-cut vs wedge-cut variants of the Weil osteotomy for the treatment of propulsive metatarsalgia.
Dr Andrew Wines
80 participants
Mar 17, 2021
Interventional
Conditions
Summary
Propulsive metatarsalgia involves pain under the metatarsal heads during the “third rocker” phase of the gait cycle. Weil osteotomy is used to surgically treat metatarsalgia, by shortening the metatarsal via a distal oblique cut. Adjunct procedures are performed for lesser toe correction when required. While Weil osteotomies are commonly performed, complications include floating toe, joint stiffness and recurrence or transfer of metatarsalgia. “Wedge” osteotomy is a modification of Weil, involving a second incision to remove a slice of bone. The procedure purportedly reduces plantar translation of the metatarsal head, maintains metatarsophalangeal centre of rotation and improves intrinsic muscle function. However, in-vivo data for the clinical efficacy of this technique is limited. This study aims to investigate whether a wedge-cut Weil osteotomy compared to the traditional flat-cut technique is associated with increased pain relief and fewer complications up to 12 months postoperatively in patients presenting with propulsive metatarsalgia. Patients will be recruited into an existing patient registry (ACTRN12620000331932) and will be randomised into the flat-cut or wedge-cut (control) Weil osteotomy groups prior to surgery. They will subsequently undergo standard of care consultation for diagnosis and treatment, including the collection of demographic data, patient medical history, radiological findings and pathology. Data collection will be completed routinely at the consulting rooms for the principal investigators.
Eligibility
Inclusion Criteria5
- Patients presenting to the participating surgeons for treatment of propulsive metatarsalgia that are:
- Over 18 years of age
- Eligible for surgical intervention, having failed a minimum 6 months of conservative interventions
- Registered in the surgeons’ practice registry (ANZCTR Registration: ACTRN12620000331932)
- Have provided written informed consent to participation in the trial
Exclusion Criteria6
- Patients that:
- Require additional procedures involving the soft tissues of the foot-ankle complex
- Have had recent (<6 months) prior surgery to the affected forefoot
- Are judged by the participating surgeons as incapable to complete patient-reported outcome measures as required for the study, for example due to psychological impairment or insufficient English language capacity. (Patients with insufficient English may still be included if it is determined that a suitable translator is present and capable of relaying information to the patient during recruitment and data collection.)
- Have withdrawn consent for information usage in the practice registry
- Have cancelled their surgery booking with the participating surgeon
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Interventions
Weil osteotomy is a distal oblique osteotomy procedure performed to treat lesser metatarsal deformities and alleviate metatarsalgia, by shortening the metatarsal in the transverse plane. While Weil osteotomies are commonly performed, complications include floating toe, joint stiffness, avascular necrosis, transfer of metatarsalgia to subsequent toes, and plantar flexion of the metatarsal. Wedge-cut osteotomy is a modification of the flat-cut Weil procedure, and includes a second incision to remove a slice of bone. The procedure is purported to reduce plantar translation of the metatarsal head, maintain the metatarsophalangeal (MTP) centre of rotation and improve intrinsic muscle function. However, there is limited in-vivo data for the clinical efficacy of this technique. In the wedge-cut Weil osteotomy group (the “experimental” intervention), participants will receive two parallel distal oblique incisions in the dorsal aspect of the metatarsal head to remove a wedge of bone, in order to reduce plantar translation while shortening the metatarsal. The osteotomy is performed with or without the following adjunct procedures for lesser toe or soft tissue correction: - Proximal interphalangeal arthrodesis - First MTP joint fusion/arthrodesis - Hallux valgus correction Weil osteotomy surgery for both the intervention and control groups will typically take less than an hour, and will be performed by a fellowship trained orthopaedic surgeon who specialises in foot, ankle and trauma surgery. Adherence to the protocol will be assessed by comparing the patient osteotomy group allocation as identified in the operation report, to the trial master sheet with the allocation information.
Locations(3)
View Full Details on ANZCTR
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ACTRN12620001251910