MetaMet: Bone Cutter Versus Bone Saw for Ray Amputation

NCT05804565 | Unknown

• 1 other identifier: 122/12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

diabetic foot infection; critical limb ischaemia; minor amputation; reulceration; wound complications

Outcome Measures

Primary Outcomes (1)

• Power Calculation for Definitive RTC

  collect sufficient data to enable an accurate power calculation for a future randomised controlled trial

  Six months

Secondary Outcomes (10)

• Rate of Surgical Re-Intervention

  Six months

• Rate of Hospital Re-Admissions

  Six months

• Time to Wound Healing

  Six months

• Rate of Index Ulcer Healing

  Six months

• Rate of Re-Infection

  six months

Study Arms (2)

Bone Saw

ACTIVE COMPARATOR

In the "intervention" arm, the metatarsal bone will be transected using an oscillating microsaw. This is an accepted surgical method.

Procedure: Bone Saw

Bone Cutter

OTHER

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

Interventions

Bone Saw PROCEDURE

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

Bone Saw

Bone Cutter PROCEDURE

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

Bone Cutter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting patients, aged 18 and over, undergoing transmetatarsal amputation of one-to-two adjacent toes

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Hospital Galway: lead

Study Sites (1)

University College Hospital Galway

Galway, H91 YR71, Ireland

RECRUITING

Related Publications (12)

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  PMID: 29843915 BACKGROUND

• Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.

  PMID: 20609967 BACKGROUND

• Geiss LS, Li Y, Hora I, Albright A, Rolka D, Gregg EW. Resurgence of Diabetes-Related Nontraumatic Lower-Extremity Amputation in the Young and Middle-Aged Adult U.S. Population. Diabetes Care. 2019 Jan;42(1):50-54. doi: 10.2337/dc18-1380. Epub 2018 Nov 8.

  PMID: 30409811 BACKGROUND

• Nolan JJ, O'Halloran D, McKenna TJ, Firth R, Redmond S. The cost of treating type 2 diabetes (CODEIRE). Ir Med J. 2006 Nov-Dec;99(10):307-10.

  PMID: 17274175 BACKGROUND

• Skrepnek GH, Mills JL Sr, Lavery LA, Armstrong DG. Health Care Service and Outcomes Among an Estimated 6.7 Million Ambulatory Care Diabetic Foot Cases in the U.S. Diabetes Care. 2017 Jul;40(7):936-942. doi: 10.2337/dc16-2189. Epub 2017 May 11.

  PMID: 28495903 BACKGROUND

• Armstrong DG, Lavery LA, Harkless LB, Van Houtum WH. Amputation and reamputation of the diabetic foot. J Am Podiatr Med Assoc. 1997 Jun;87(6):255-9. doi: 10.7547/87507315-87-6-255.

  PMID: 9198345 BACKGROUND

• Rathnayake A, Saboo A, Malabu UH, Falhammar H. Lower extremity amputations and long-term outcomes in diabetic foot ulcers: A systematic review. World J Diabetes. 2020 Sep 15;11(9):391-399. doi: 10.4239/wjd.v11.i9.391.

  PMID: 32994867 BACKGROUND

• Collins PM, Joyce DP, O'Beirn ES, Elkady R, Boyle E, Egan B, Tierney S. Re-amputation and survival following toe amputation: outcome data from a tertiary referral centre. Ir J Med Sci. 2022 Jun;191(3):1193-1199. doi: 10.1007/s11845-021-02682-4. Epub 2021 Jun 22.

  PMID: 34156661 BACKGROUND

• Acar E, Kacira BK. Predictors of Lower Extremity Amputation and Reamputation Associated With the Diabetic Foot. J Foot Ankle Surg. 2017 Nov-Dec;56(6):1218-1222. doi: 10.1053/j.jfas.2017.06.004. Epub 2017 Jul 29.

  PMID: 28765052 BACKGROUND

• Liu R, Petersen BJ, Rothenberg GM, Armstrong DG. Lower extremity reamputation in people with diabetes: a systematic review and meta-analysis. BMJ Open Diabetes Res Care. 2021 Jun;9(1):e002325. doi: 10.1136/bmjdrc-2021-002325.

  PMID: 34112651 BACKGROUND

• Norvell DC, Czerniecki JM. Risks and Risk Factors for Ipsilateral Re-Amputation in the First Year Following First Major Unilateral Dysvascular Amputation. Eur J Vasc Endovasc Surg. 2020 Oct;60(4):614-621. doi: 10.1016/j.ejvs.2020.06.026. Epub 2020 Aug 13.

  PMID: 32800475 BACKGROUND

• Moodley B, Grabowski G, Altschuler M, Williams M. Use of the Gigli saw for transmetatarsal amputations. J Foot Ankle Surg. 2005 Sep-Oct;44(5):415-8. doi: 10.1053/j.jfas.2005.07.013. No abstract available.

  PMID: 16210164 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Gangrene; Wound Infection; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Ischemia

Study Officials

• Stewart R Walsh, FRCS

  University College Hospital Galway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Power Foley, MRCS

CONTACT

871312557; foleymp@tcd.ie

Stewart Walsh, FRCS

CONTACT

871421564; stewartredmond.walsh@nuigalway.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: patient-blinded, assessor-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar in Vascular Surgery

Model Details: 1:1 parallel randomised controlled trial

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-03

Locations

IE (1)