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Evaluation of effect of platelet(blood component) in achieving union in stabilized fracture non union

Evaluation of efficacy of platelet concentrate in the treatment of non-union of fracture of long bones.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2012/10/003079
Enrollment
50
Registered
2012-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- fracture of long bones with implant.

Interventions

Intervention1: observational study: The platelet concentrate would be obtained from patients own blood 55 ml) using the SYMPHONY platelet concentrate system. The patients with atrophic non-union with

Sponsors

Indian Council of Medical ResearchICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients who has fracture of long bones (femur, tibia, humerus, radius and ulna)and atleast 6 months have passed since the time of injury and there are no clinical radiological signs of bone union. only patients with signs of atrophis non union would be included in the study.

Exclusion criteria

Exclusion criteria: 1. Patients not willing to undergo treatment. 2. patients of age more than 50 years and age less than 20 years 3. Patients with history of compound fractures. 4. Patients with previous history of metabolic disorders. 5. Patients with history of steroid intake 6. Patients with history of Endocrine disorders requiring treatment 7. Abnormal renal or liver function. 8. Patients with hypertrophic non union. 9. Patients with non union gap of more than 10 mm

Design outcomes

Primary

MeasureTime frame
76 patients patients were included in this study with average age was 34.5 years. 62 patients (82%) shows signs of union after platelet injection at 3 years of follow up.Timepoint: 76 patients were recruited in 3 years. evaluted after 3 years.

Secondary

MeasureTime frame
7 fracture united out of 10 in first year. all 18 fractures unites in second year. 37 patients showed signs of union out of 48 patients in third year.Timepoint: 10 patients were included in first year. 18 patients were included in second year. 48 patients were included in third year.

Countries

India

Contacts

Public ContactProf R Malhotra

All India Institute of Medical Science (AIIMS)

rmalhotra62@hotmail.com26593589

Outcome results

None listed

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