Health Condition 1: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified
Conditions
Interventions
Intervention1: Pre-emptive Regenerative Peripheral Nerve Interface: RPNI involves a free muscle graft (frequently vastus lateralis) that is neurotized by a transected peripheral nerve, with the muscle
Sponsors
JPNATC AIIMS New Delhi
Dr Abhinav Kumar
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patients undergoing transfemoral/transtibial amputation 2. Hemodynamically stable patients 3. Patients between the ages of 18-65 years
Exclusion criteria
Exclusion criteria: 1. Patients who do not consent to the study 2. Proximal injury to the sciatic nerve, quadriplegia and paraplegia 3. Patients with severe or moderate head injury, unable to follow directions and comply with treatment 4. Patients who need ventilator support for more than 48-72 hours 5. Pregnant females 6. Known psychiatry illness Post randomisation exclusion Patient who requires stump revision or debridement after RPNI will be excluded Death of patients, if any. Intensive Care Unit (ICU) stay of more than 48-72 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| residual limb pain(RLP) by using the Numerical Rating Scale(NRS) pain score between the RPNI group(Intervention group) and the conventional(Traction Neurectomy) group in patients undergoing transfemoral/transtibial amputation is lesser in RPNI when compared to traction neurectomy groupTimepoint: 1 week, 1 month and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Phantom limb pain(PLP) and Incidence of neuroma are both lesser in RPNI groupTimepoint: 1 week, 1 month and 3 months;Comparison of Numerical Rating scale, PainDETECT, PROMIS-P and HADS score between RPNI and traction neurectomy groupsTimepoint: 1 week, 1 month and 3 months | — |
Countries
India
Contacts
Public ContactDr Abhijit B R
JPNATC, AIIMS, New Delhi
Outcome results
None listed