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Immediate prosthesis in traumatic above knee amputation patient

To study the effect of Immediate Post Operative Prosthesis in relation to post surgical outcome, balance and quality of life in Above Knee Amputation patients (post traumatic): A Pilot Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057643
Enrollment
60
Registered
2023-09-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: S781- Traumatic amputation at level between hip and knee

Interventions

Intervention1: Immediate Post Operative Prosthesis in traumatic above knee amputee.: Patient of the intervention group will be provided with IPOP and will be assesed for blood marker, psychological sc

Sponsors

Indian Council of Medical Research New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • IPD patients • Heamodynamically stable patients. •Above knee amputation patient. •Age 18-65. •Both genders. •Patient not necessitating ICU care for more than 48 hours

Exclusion criteria

Exclusion criteria: •Revision amputation patients. •Children below 18 years of age •Pregnant and lactating females •Patient with co-morbidity like cardiac condition, malignancies, bleeding disorder. •Patients on antiepileptic and thyroid drugs. •Patient with premorbid history of infection. •Patient with associated fracture of the contra lateral lower limb, pelvic fracture or intubated patient. •Patient with head or spine injury. •Injuries due to which patients cannot be mobilized even after 48 hours of injury

Design outcomes

Primary

MeasureTime frame
1. To study the effect of immediate post-operative prosthesis on balance, quality of life, depression and anxiety. 2.To compare between IPOP and conventional prosthesis in relation to balance, quality of life, depression and anxiety. 3.To study the effects of IPOP on stress biomarkers: serotonin 5-HT and Serum endorphin. Timepoint: Post amputation within 24 hours baseline assessment and follow up assessment at 6 weeks, 12 weeks and 6 months.—

Secondary

MeasureTime frame
1.To minimize the period of recovery in above knee amputation patient. 2.To evaluate the effect of IPOP at 6 weeks and 6 months after application of prosthesis Timepoint: Post amputation within 24 hours baseline assessment and follow up assessment at 6 weeks, 12 weeks and 6 months.—

Countries

India

Contacts

Public ContactDr Junaid Alam

All India Institute of Medical Sciences New Delhi

dr.junaidaiims@gmail.com011-26731061

Outcome results

None listed

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