Modified vs Standard Procedures for Amputation

Recruiting at3 trial locations

Overseen by Matthew J Carty, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brigham and Women's Hospital

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Severe illness, Active infections, Neuropathies, Smoking, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new surgical method for arm amputations to improve the use of advanced prosthetic limbs. It targets patients needing above or below elbow amputations. The technique uses remaining muscles to create natural movement and sensation, enhancing control and feedback with prosthetics. A method that directly attaches a prosthesis to the bone has been developed to improve prosthetic function and user experience.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking immunosuppressive agents or are on chronic steroid therapy.

What data supports the effectiveness of the modified amputation procedure treatment?

The research suggests that more distal (further from the body) amputations, which are often part of modified procedures, can lead to fewer complications if done early and with careful evaluation. This implies that modified procedures might be more effective in reducing complications compared to standard procedures. ^{1 2 3 4 5}

Is the modified or standard amputation procedure generally safe for humans?

The research articles provided do not contain specific safety data for modified or standard amputation procedures, but they discuss factors like re-amputation and outcomes related to different amputation levels, which can indirectly inform safety considerations. ^{2 6 7 8 9}

How does the modified amputation procedure differ from standard procedures?

The modified amputation procedure is unique because it involves specific modifications like contouring bones and transferring tendons to prevent complications such as foot deformities and skin breakdown, which are common in traditional procedures. This approach has shown to be functional and complication-free in children over a 3.5-year follow-up. ^{10 11 12 13 14}

Research Team

Matthew J Carty, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults aged 18-65 who need an arm amputation due to injury, birth defects, or arthritis. They must be healthy enough for surgery under general anesthesia and motivated to follow up post-surgery. Good communication skills are required as they'll report on their recovery.

Inclusion Criteria

You are ready and willing to attend all the follow-up appointments after surgery.

You agree to take part in the study at Massachusetts Institute of Technology for some of the tests and measurements.

I am healthy enough for surgery and general anesthesia.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Modified above elbow or below elbow amputations are performed on intervention patients

1 week

1 visit (in-person)

Postoperative Rehabilitation

Development of a modified acute postoperative rehabilitation strategy suited to the new surgical approach

4-8 weeks

Follow-up

Participants are monitored for safety, effectiveness, and recovery of motor and sensory functions

36 months

Treatment Details

Interventions

• Modified amputation procedure (Procedure)
• Standard amputation procedure (Procedure)

Trial Overview The study tests a new way of performing arm amputations aimed at improving control over advanced prosthetics and restoring sensation. Ten patients will receive this modified procedure and their results will be compared with ten receiving traditional amputations.

Participant Groups

Group I: Intervention group Experimental Treatment 1 Intervention

Modified amputation procedure

Group II: Control group Active Control 1 Intervention

Standard amputation procedure

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Massachusetts Institute of Technology

Collaborator

Trials

104

Recruited

12,810,000+

Sally Kornbluth

Massachusetts Institute of Technology

Chief Executive Officer since 2023

PhD in Molecular Biology from Rockefeller University

Angela Koehler

Massachusetts Institute of Technology

Chief Medical Officer

MD from Harvard Medical School

Walter Reed Army Institute of Research (WRAIR)

Collaborator

Trials

111

Recruited

108,000+

Colonel Eli Lozano

Walter Reed Army Institute of Research (WRAIR)

Chief Executive Officer since 2023

BSc from United States Military Academy at West Point, Master's in Health Care Administration from Baylor University, Master's in Strategic Studies from U.S. Air War College

Dr. Deborah Shear

Walter Reed Army Institute of Research (WRAIR)

Chief Medical Officer since 2023

MD from Uniformed Services University of the Health Sciences

Findings from Research

In a study of 250 patients undergoing stump revision surgery over a 10-year period, the overall surgical success rate was 81%, with the best outcomes seen in revisions for bony pathology (100% success).

Revisions for soft tissue pathology and neuromas showed satisfactory results, but caution is advised for cases involving non-neuroma pain, as these had poorer surgical success rates, highlighting the importance of careful patient selection for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amputation Revision Surgery - Refining the surgical approach. Ten years of experience and 250 cases, impressions, outcomes, and thoughts for the future. Forbes, MKE., Cobb, MW., Jeevaratnam, MJ., et al.[2022]

In a study of over 14,000 patients who underwent major lower extremity amputations, only 1.8% required early re-amputation within 30 days, but this was linked to significantly worse outcomes, including longer hospital stays and higher readmission rates.

Risk factors for early re-amputation included advanced age, smoking, dialysis dependence, preoperative septic shock, and bleeding disorders, highlighting the importance of patient assessment before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Early Lower Extremity Re-amputation. Zambetti, BR., Stiles, ZE., Gupta, PK., et al.[2022]

In a study of 146 patients who underwent toe amputation, nearly 43.2% progressed to further minor or major amputations within an average of 36 months, indicating a significant risk of additional procedures after the initial amputation.

Despite the high rate of further amputations, the study found that 5-year survival rates were relatively high, with 64.3% of patients alive, and there was no significant difference in outcomes between those who had hallux versus non-hallux amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-amputation and survival following toe amputation: outcome data from a tertiary referral centre. Collins, PM., Joyce, DP., O'Beirn, ES., et al.[2022]

The study indicates that more distal amputations are associated with a higher incidence of local complications, suggesting that careful consideration is needed when deciding the level of amputation.

Interestingly, the data also show that postoperative mortality decreases with more distal amputations, highlighting the importance of early indication and accurate evaluation in surgical decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Economic amputations of the lower limbs due to ischemia. II]. Giaccone, M., Murix, EL., Bertero, D., et al.[2022]

In a study of 70 patients (36 men and 34 women) aged 72 on average, 16% experienced early amputation failure within 30 days, either through death or re-amputation, highlighting a significant risk associated with major non-traumatic lower-extremity amputations.

No specific preoperative factors, including skin perfusion tests, were found to predict early amputation failure, indicating a need for better pre-amputation assessment tools to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Difficult to predict early failure after major lower-extremity amputations. Kristensen, MT., Holm, G., Gebuhr, P.[2022]

The overall rate of lower limb amputations in Germany remained stable at 0.04% from 2006 to 2012, with approximately 49,150 cases identified in 2012, indicating a consistent prevalence in the population.

Among patients with diabetes mellitus and arterial occlusive disease, there was a slight decrease in the amputation rate per patient, despite a 10.4% increase in diabetes prevalence, highlighting the need for enhanced preventive measures to further reduce amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and Regional Distribution of Lower Limb Amputations from 2006 to 2012 in Germany: A Population based Study. Heyer, K., Debus, ES., Mayerhoff, L., et al.[2022]

The prevalence of lower extremity amputation (LEA) in patients with type 2 diabetes decreased by 72% over a 15-year period, from 1.2% in the first phase of the Fremantle Diabetes Study (FDS1) to 1.0% in the second phase (FDS2), indicating improved outcomes for diabetic patients.

Key factors associated with a lower risk of LEA included a history of vascular bypass surgery, past hospitalizations for foot ulcers, and better kidney function, suggesting that targeted healthcare initiatives in primary care may have contributed to this significant reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal changes in the prevalence and associates of diabetes-related lower extremity amputations in patients with type 2 diabetes: the Fremantle Diabetes Study. Baba, M., Davis, WA., Norman, PE., et al.[2022]

Over an 11-year period, 891 patients underwent major lower extremity amputations (LEAs) in Southwest Finland, with a notable decrease in incidence among those under 65 years old, indicating potential improvements in prevention or management strategies for younger patients.

Despite the availability of vascular services, many older patients remain unsuitable for revascularization, leading to LEA as the only viable treatment for critical limb ischemia, highlighting the need for better interventions in this aging population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major Lower Limb Amputations and Amputees in an Aging Population in Southwest Finland 2007-2017. Koivunen, V., Dabravolskaite, V., Nikulainen, V., et al.[2022]

In a study of 7,296 veterans undergoing lower extremity amputations, it was found that racial and ethnic disparities exist in the choice of amputation level, with higher rates of transfemoral (TF) amputations among Hispanic veterans (46%) compared to White (31%) and Black (35%) veterans.

Geographic region also plays a role, as Black veterans without prior revascularization were more likely to undergo TF amputations compared to White veterans, and in the Southeast, Hispanic veterans had significantly higher odds of TF amputations compared to Whites, indicating a need for targeted interventions to address these disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Racial and ethnic amputation level disparities in veterans undergoing incident dysvascular lower extremity amputation. Hurwitz, M., Norvell, DC., Czerniecki, JM.[2022]

The modified Chopart's amputation, which includes several surgical enhancements, has been performed on eight feet in six children without any complications over an average follow-up of 3.5 years.

This procedure effectively addresses issues associated with traditional Chopart's amputation, making it a promising option for children needing foot ablation due to congenital malformations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The modified Chopart's amputation. Letts, M., Pyper, A.[2022]

Transmetatarsal amputation is a beneficial option as it preserves foot function, is cosmetically acceptable, and does not necessitate the use of a prosthesis.

Both Lisfranc and Chopart amputations can lead to equinovarus deformity, which requires Achilles tendon lengthening, but with proper patient motivation and surgical expertise, satisfactory limb salvage outcomes can be achieved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transmetatarsal and midfoot amputations. Sanders, LJ.[2022]

In a study of 94 diabetes patients, those who underwent minor amputations (below the ankle) demonstrated significantly better independence and quality of life compared to those who had major amputations (above the ankle), with 84.5% of minor amputation patients able to walk independently versus only 41.7% of major amputation patients.

Despite some complications associated with minor amputations, such as persistent infection, the overall benefits in physical functioning and mental health suggest that minor amputation is a preferable option for improving the quality of life in diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life of diabetes amputees following major and minor lower limb amputations. Nazri, MY., Aminudin, CA., Ahmad, FS., et al.[2022]

In a study of 64 solid organ transplant recipients with lower extremity wounds, 73.4% required amputations, with a significant number of those (57.1%) progressing to higher levels of amputation, indicating challenges in limb salvage for this population.

The nonamputation group showed a high healing rate of 88.2%, suggesting that surgical management can be effective for some patients, but preexisting health conditions and immunosuppressive treatments complicate outcomes and warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Management of Lower Extremity Wounds in the Solid Organ Transplant Patient Population: Surgeon Beware. Abu El Hawa, AA., Bekeny, JC., Dekker, PK., et al.[2023]

Staged amputation (SA) demonstrated a higher technical success rate (77.2%) and lower perioperative (10.9%) and 30-day mortality rates (12.2%) compared to one-stage amputation (OSA) with success rates of 66.0% and mortality rates of 20.7% and 23.8%, respectively, in a study of 185 patients with critical limb ischemia.

Despite SA involving more patients with severe conditions like diabetes and infection, it still outperformed OSA, suggesting that SA may be a safer and more effective option for amputations in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of One-Stage or Staged Amputations of Lower Limbs Consequent to Critical Limb Ischemia and Infection. Silva, LR., Fernandes, GM., Morales, NU., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Amputation Revision Surgery - Refining the surgical approach. Ten years of experience and 250 cases, impressions, outcomes, and thoughts for the future. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Analysis of Early Lower Extremity Re-amputation. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Re-amputation and survival following toe amputation: outcome data from a tertiary referral centre. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

[Economic amputations of the lower limbs due to ischemia. II]. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

Difficult to predict early failure after major lower-extremity amputations. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Prevalence and Regional Distribution of Lower Limb Amputations from 2006 to 2012 in Germany: A Population based Study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Temporal changes in the prevalence and associates of diabetes-related lower extremity amputations in patients with type 2 diabetes: the Fremantle Diabetes Study. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Major Lower Limb Amputations and Amputees in an Aging Population in Southwest Finland 2007-2017. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Racial and ethnic amputation level disparities in veterans undergoing incident dysvascular lower extremity amputation. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The modified Chopart's amputation. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Transmetatarsal and midfoot amputations. [2022]

12. Malaysia pubmed.ncbi.nlm.nih.gov

Quality of life of diabetes amputees following major and minor lower limb amputations. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Surgical Management of Lower Extremity Wounds in the Solid Organ Transplant Patient Population: Surgeon Beware. [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Results of One-Stage or Staged Amputations of Lower Limbs Consequent to Critical Limb Ischemia and Infection. [2022]