MetaMet: Bone Cutter Versus Bone Saw for Ray Amputation

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Toe amputation is a common minor vascular procedure and is increasingly performed in the context of irretrievable diabetic foot infection, with and without concurrent ischaemia. Approximately 422 million people worldwide have diabetes mellitus and peripheral arterial disease (PAD) affects approximately 200 million people(1). The intersection between diabetes, neuro-ischaemic foot ulceration and lower limb amputations is well established(2). Recently published data from the United States reported overall rates of lower limb amputations in diabetic patients rose between 2000 and 2015, in part due to a 62% increase in the rate of minor (foot and toe) amputations(3). It is estimated that 6% of Irish adults are diabetic; from this, we can extrapolate the burden of managing diabetic foot complications(4). Resource utilisation notwithstanding, the financial costs of managing diabetic foot complications are estimated to outstrip some cancers(5). As the prevalence of diabetes mellitus rises amongst an ageing Irish population, the importance of achieving durable functional outcomes after partial foot amputation is paramount. Re-ulceration, re-infection, re-amputation and hospital re-admission after partial foot amputation for digital gangrene is well documented in the literature in both diabetic and PAD cohorts(6). Across the literature, rates of re-amputation at five years post-index surgery for diabetic foot complications range from 45-65% (6, 7). A recent study by Collins et al reported that, out of 146 Irish patients undergoing minor amputations, 43% (n=63) required further ipsilateral amputation, 21 (14.4%) of which were trans-tibial or trans-femoral(8). Chronic kidney disease, diabetes with or without poor gylcaemic control, peripheral neuropathy, peripheral arterial disease, ongoing tobacco smoking, obesity (BMI >30), concurrent sepsis at the time of index operation have all been identified as independent risk factors for amputation failure and the need for revision(9-11). While numerous studies have investigated patient-dependent factors predictive of amputation failure, there is a dearth of evidence examining the impact of surgical technique on this commonly performed procedure. An exhaustive search of the literature surrounding surgical technique and outcomes after ray amputation yielded several papers on the benefits of various soft tissue flaps for covering wound defects but just one detailing a particular methods of bone transection. However, Moodley et al focused on the use of a Gigli saw, which is beyond the scope of this feasibility study(12). There have been no randomised controlled trials evaluating the impact of metatarsal transection method on outcomes after ray amputation, specifically whether a manual bone cutter or an electric/oscillating/pneumatic bone saw were used. We hypothesise that utilising a manual bone cutter is more subject to inter-user variability, as it depends on the physical strength of the operating surgeon; improperly applied forces are liable to fracture the remaining bone, leaving small comminuted fragments that may become necrotic and act as a nidus for further infection within the wound bed. Furthermore, using an oscillating microsaw has the advantage of providing a clean bony transection regardless of the physical strength of the operator, however it may cause more damage to the surrounding connective tissues and disturb microvascular periosteal supply, which could also lead to osteonecrosis. We propose a pilot randomised controlled trial to test the feasibility and to generate sufficient data to permit sample size calculation for a trial designed to evaluate the outcomes after ray amputation using either a bone cutter or a bone saw.

Official Title
-----------------
Randomised Controlled Trial Comparing Metatarsal Method of Transection Using Bone Cutters or Bone Saw on Outcomes After Ray Amputation (MetaMet)

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

Intervention / Treatment
-----------------
* Procedure: Bone Saw
* Procedure: Bone Cutter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consenting patients, aged 18 and over, undergoing transmetatarsal amputation of one-to-two adjacent toes Exclusion Criteria: Significant peripheral arterial disease, as defined by ABPI <0.4 or digital pressures of <50mmHg, not undergoing concurrent revascularisation; Patients undergoing amputation of three of more adjacent toes Patients unfit for surgery; Patients unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 parallel randomised controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bone Saw<br>In the intervention arm, the metatarsal bone will be transected using an oscillating microsaw. This is an accepted surgical method. | Procedure: Bone Saw<br>* The surgeon will use an oscillating microsaw to transect the metatarsal shaft<br>|
| Other: Bone Cutter<br>In the control arm, the metatarsal bone will be transected using a manual bone cutters. This is also an accepted surgical method | Procedure: Bone Cutter<br>* The surgeon will use a manual bone cutter to transect the metatarsal shaft<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Power Calculation for Definitive RTC | collect sufficient data to enable an accurate power calculation for a future randomised controlled trial | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Surgical Re-Intervention | To determine the effect of microsaw compared to bone cutters for toe amputation on rates of surgical reintervention at the index procedure site | Six months | 
| Rate of Hospital Re-Admissions | To determine the effect of microsaw compared to bone cutters for toe amputation on rates of hospital re-admissions directly related to the index surgical procedure | Six months | 
| Time to Wound Healing | To determine the effect of microsaw compared to bone cutters for toe amputation on time to healing of the index surgical wound | Six months | 
| Rate of Index Ulcer Healing | To determine the effect of microsaw compared to bone cutters for toe amputation on healing of the index ulcer | Six months | 
| Rate of Re-Infection | To determine the effect of microsaw compared to bone cutters for toe amputation on rates of re-infection at the index procedure site | six months | 
| Rate of Ulcer Recurrence | To determine the effect of microsaw compared to bone cutters for toe amputation on ulcer recurrence or further ulceration | Six months | 
| Rate of Recurrent Osteomyelitis | To determine the effect of microsaw compared to bone cutters for toe amputation on osteomyelitis recurrence adjacent to the index surgical site | Six months | 
| Rate of Resection Margin Positive Culture | To determine the effect of microsaw compared to bone cutters for toe amputation on resection margin culture positivity | Six months | 
| Patient-Reported Post-Operation Pain | To determine the effect of microsaw compared to bone cutters for toe amputation on patient-reported post-operative pain, as measured by the Verbal Rating Scale (VRS) | Six Months | 
| Patient-Reported Quality of Life | To determine the effect of microsaw compared to bone cutters for toe amputation on patient-reported health-related quality of life at six weeks and six months, as measured by the EQ-5D-5L tool | Six Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic foot infection, critical limb ischaemia, minor amputation, reulceration, wound complications