MetaMet: Bone Cutter Versus Bone Saw for Ray Amputation

Summary

Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor wound healing, new infections and/or new ulcers. Research to date has focused on patient-related factors associated with poor wound healing (e.g. diabetes, lack of blood flow, poor kidney function). However, there is no research looking at the technical surgical aspects of the procedure, specifically how the toe bone is cut.

For this feasibility study, we will recruit forty patients whom a consultant vascular surgeon has decided requires amputation of one-to-two adjacent toes. The participants will be randomised by a computer model into one of the two metatarsal transection methods (bone cutters or bone saw) and the rest of the procedure will be carried out in the standard fashion. Patients and assessors will be blinded to which transection method is chosen.

Patients will undergo a post-operative foot x-ray to assess for bone fragments within 48 hours of surgery and another at six months to assess for bone healing. Patients will be asked to rate their pain in the post-operative period using the verbal rating score. Patients will be followed after discharge from hospital by their public health nurse, as is standard practice, with regular follow-up in the surgical outpatients to assess wound progress. Patients will be asked to rate their quality of life at six weeks and six months post-operatively. These assessments will be coordinated with their routine post-operative follow-up clinic appointments, so as not to inconvenience patients with supernumerary visits.

Conditions

• Diabetic Foot
• Gangrene; Limb
• Wound Infection
• Wound Healing Delayed
• Wound Complication
• Critical Limb-Threatening Ischaemia
• Amputation

Interventions

PROCEDURE

Bone Saw

The surgeon will use an oscillating microsaw to transect the metatarsal shaft

PROCEDURE

Bone Cutter

The surgeon will use a manual bone cutter to transect the metatarsal shaft

Sponsors & Collaborators

• University College Hospital Galway

  lead OTHER

Principal Investigators

• Stewart R Walsh, FRCS · University College Hospital Galway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2023-12-31

Completion

2024-06-30

Countries

• Ireland

Study Locations