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To evaluate the effect of platelet-rich plasma in bone healing of acute diaphyseal fractures of the tibia

Phase 4
Recruiting
Conditions
patients who ere diagnosed as acute closed fracture of tibial shaft and underwent surgery with intramedullary nail
platelet-rich plasma, prp, tibia fracture, bone healing, cortex-to-callus ratio, biological augmentation, regenerative medicine
Registration Number
TCTR20210220003
Lead Sponsor
H.R.H. Maha Chakri Sirindhorn Medical Center (MSMC)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
32
Inclusion Criteria

(1) Age between 18-60 years old
(2) New case of tibial fracture within 1 week
(3) No life threatening conditions
(4) No smoking or stop at least 3 months
(5) No underlying disease that inhibit bone healing
(6) No drug use that involve in calcium regulator
(7) Minimum follow-up of 6 month after surgery

Exclusion Criteria

(1) Post operative infection
(2) Open diaphyseal fracture
(3) Traumatic event at the same affected part that need to re-operative
(4) Poor compliance

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
size of callus formation 1 to 6 months of follow up Cortex-to-callus ratio
Secondary Outcome Measures
NameTimeMethod
Patient reported outcome at 6 months of follow up VAS, EQ-5D-3L, SF-36
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