RecruitingACTRN12620001251910

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.

Sponsor

Dr Andrew Wines

Enrollment

80 participants

Start Date

Mar 17, 2021

Study Type

Interventional

Conditions

Propulsive metatarsalgia

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two surgical techniques for treating metatarsalgia — a condition causing persistent pain in the ball of the foot under the long bones of the foot (metatarsal heads). The pain typically occurs during walking or standing and is often caused by excess pressure on these bones. When conservative treatments (such as orthotics and footwear modifications) don't work, surgery to shorten the affected metatarsal bone (a Weil osteotomy) may be recommended. This trial compares the traditional 'flat-cut' Weil osteotomy with a modified 'wedge-cut' version, which removes a small slice of bone to potentially reduce one of the main complications — a 'floating toe' that doesn't rest naturally on the ground. Both techniques are performed by experienced surgeons, and participants' pain and complications are tracked for 12 months after surgery. You may be eligible if you are 18 or older, are being treated for metatarsalgia by a participating surgeon, have tried conservative treatment for at least 6 months without sufficient relief, and have provided written consent. Patients requiring additional soft tissue surgery, who have had recent forefoot surgery, or who cannot complete outcome questionnaires are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

St George Private Hospital - Kogarah

NSW, Australia

North Shore Private Hospital - St Leonards

NSW, Australia

Castlecrag Private Hospital - Castlecrag

NSW, Australia

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ACTRN12620001251910