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

Comparison of the Results of Tibial or Femoral Non-union Treatment with Two Methods "Internal Fixation + Autologous Bone Graft" and "Internal Fixation + Allogenic Umbilical Cord Mesenchymal Stem Cells"

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221009056121N2

Enrollment

Registered

2022-12-13

Start date

2022-12-22

Completion date

Unknown

Last updated

2023-02-07

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

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

Interventions

Intervention 1: Intervention group: Nonunion of the Tibial or Femoral Bone undergoes Internal Fixation and Allogeneic Mesenchymal Stem Cells of Umbilical Cord Origin Implanted in Fibrin Gel are used t

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Union 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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Najafi

Tehran University of Medical Sciences

ehsan.n.6384@gmail.com+98 21 8490 1000

Outcome results

None listed

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