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Comparison of pain status in patients undergoing nerve to nerve anastomosis versus no anastomosis following post traumatic above knee amputation: A Randomised control trial

Comparison of pain status in patients undergoing Targeted Muscle reinnervation versus Conventional stump preparation following post traumatic above knee amputation: A Randomised control trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079118
Enrollment
74
Registered
2025-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system Health Condition 2: S781- Traumatic amputation at level between hip and knee

Interventions

Intervention1: Targeted Muscle Reinnervation: Targeted muscle reinnervation will be done at the time of index amputation. Patients with undergo above knee amputation following which targeted muscle re

Sponsors

AIIMS , New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients undergoing above knee amputation Hemodynamically stable patients

Exclusion criteria

Exclusion criteria: Patients who do not consent for the study Proximal injury to the sciatic nerve, quadriplegia and paraplegia Patients with severe or moderate head injury, unable to follow directions and comply with treatment Patients who needs ventilator support for more than 48-72 hours Pregnant females Known psychiatry illness Post Randomization exclusion: Patient who requires stump revision or debridement after TMR will be excluded Death of patient Patients wishing to drop from the study at any point of time

Design outcomes

Primary

MeasureTime frame
To compare the residual limb pain (RLP) by using pain scores which includes Numerical rating scale (NRS) between the targeted muscle reinnervation group (Intervention group) and conventional group in patients with above knee amputation. Timepoint: 48-72hrs, 2weeks, 4 weeks, 8 weeks, 12 weeks

Secondary

MeasureTime frame
To compare the phantom limb pain(PLP) by using Numerical rating scaleTimepoint: 48-72hrs, 2weeks, 4 weeks, 8weeks, 12 weeks;To assess the incidence of RLP and PLPTimepoint: 48-72hrs, 2weeks, 4 weeks, 8 weeks, 12 weeks;Neuroma formation using high frequency ultrasoundTimepoint: 12 weeks;Difference in pain scores like NRS, McGill, HADS, PROMISTimepoint: 48-72hrs, 2weeks, 4 weeks, 8 weeks, 12 weeks

Countries

India

Contacts

Public ContactDr Abhinav Kumar

JPNATC, AIIMS, New Delhi

drabhinav1975@gmail.com9311157766

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026