To evaluate and compare the results of use of platelet rich fibrin in trochanteric fractures of the femur fixed with proximal femoral nail by assessing clinically and radiologically
- Conditions
- Pertrochanteric fracture,
- Registration Number
- CTRI/2023/06/054113
- Lead Sponsor
- MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED LOK NAYAK HOSPITAL
- Brief Summary
Thepresent study has been designed as an intervention comparative study toevaluate the effect of platelet rich fibrin in bone union and its clinicaloutcome when given at site of fracture during internal fixation in trochantericfractures. Patientswith trochanteric fractures of femur are invited to participate in this study. If they are fulfilling the inclusion criteria they will undergo a standardizedhistory and physical examination by clinicians.All the eligible patients willbe divided in two groups after randomisation and allocation with the help ofcomputer and sequential sealed envelope method. After randomisation twogroups(Group N and Group PRF) will be created. If they are in the PRF group then they will receive PRF injection along with standard treatment. Written informedconsent will be taken from all patients partcipating in the study andadditional consent for PRF injection will be taken from patients in **Group PRF**. During the surgery, 20 ml ofblood will be taken from patient which might cause some discomfort due toneedle prick and which will be used to make platelet rich fibrin using a centrifuge,This PRF will be injected to fracture site. Patient will be assessed postoperatively clinically using Visualanalogue scale and Harris Hip Score and radiologically using RUSH Score. If youare willing to participate in the study then you have to undergo a follow up ofatleast 6 months which include 4 visits. At each follow up you will be assessed clinicallyand radiologically.X rays will be done at 2 weeks, 6 weeks, 3 months, and ifnecessary at 6months
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- 1.All patients with trochanteric femur fracture in the age group 30.
- 85 years. 2.All trochanteric fractures surgically stabilized with proximal femoral nail with helical blade.
- 1.Open trochanteric fractures 2.Pathological trochanteric fractures 3.Platelet count less than 1.2 lakhs.
- 4.Patient on any medication altering the platelet count or the function.
- 5.Immunocompromised patient.
- Any systemic infections which impair normal healing.
- Metabolic bone disease.
- 8.Patients of unsound mind or undergoing psychiatric treatment 9.HIV, diabetic, HbsAg positive patients or any patient requiring universal precaution.
- Patients of stroke, hemiplegia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PRIMARY: Assessment of radiological union by using RUSH score for trochanteric fractures femur. 1 year
- Secondary Outcome Measures
Name Time Method Clinical status will be evaluated by assessing the functional status of patients using Harris hip score & visual analogue scale for pain & any complications related to use of PRF will be recorded.
Trial Locations
- Locations (1)
Lok Nayak hospital
🇮🇳Central, DELHI, India
Lok Nayak hospital🇮🇳Central, DELHI, IndiaYASH JAINPrincipal investigator8299452373dryashjain20@gmail.com