Comparison of the Effect of Stem Cells and Bone Grafting in the Treatment of Thigh or leg Bone Non-unio

Not Applicable

Recruiting

• Conditions: Condition 1: Tibial Non-union. Condition 2: Femoral Non-union.; Unspecified fracture of shaft of unspecified tibia, subsequent encounter for closed fracture with nonunion; Unspecified fracture of shaft of unspecified femur, subsequent encounter for closed fracture with nonunion; S82.209K; S72.309K

• Registration Number: IRCT20221009056121N2
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Having Tibial of Femoral Non-union
At Least 3 Months Between Fracture and Surgical Treatment
Consent of the Patient to Participate in the Study

Exclusion Criteria

Previous Surgery on the Thigh or Leg
Hip, Knee of Ankle Osteoarthritis
Presence of Accompanying Injury in Thigh or Leg

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nion of Tibial Bone. Timepoint: 3, 6, 9, 12, 24, 48 and 96 Months After Surgery. Method of measurement: Antero-posterior and Lateral Radiography of the Leg.;Union of Femoral Bone. Timepoint: 3, 6, 9, 12, 24, 48 and 96 Months After Surgery. Method of measurement: Antero-posterior and Lateral Radiography of the Thigh.

Secondary Outcome Measures

Name	Time	Method
Pain. Timepoint: 3, 6, 9, 12, 24, 48 and 96 Months After Surgery. Method of measurement: Visual Analogue Scale.;Function. Timepoint: 3, 6, 9, 12, 24, 48 and 96 Months After Surgery. Method of measurement: Ask the Patient.;Time to Union. Timepoint: 3, 6, 9, 12, 24, 48 and 96 Months After Surgery. Method of measurement: Week.;Hip Range of Motion. Timepoint: 3, 6, 9, 12, 24, 48 and 96 Months After Surgery. Method of measurement: Clinical Examination (Degree).;Knee Range of Motion. Timepoint: 3, 6, 9, 12, 24, 48 and 96 Months After Surgery. Method of measurement: Clinical Examination (Degree).;Ankle Range of Motion. Timepoint: 3, 6, 9, 12, 24, 48 and 96 Months After Surgery. Method of measurement: Clinical Examination (Degree).;Surgical Complications. Timepoint: 3, 6, 9, 12, 24, 48 and 96 Months After Surgery. Method of measurement: Clinical Examination.;Satisfaction with Surgery. Timepoint: 3, 6, 9, 12, 24, 48 and 96 Months After Surgery. Method of measurement: Ask the Patient.