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

Comparison of the Results of Scaphoid Non-union Treatment with Two Methods "Internal Fixation + Autologous Bone Graft" and "Internal Fixation + Allogenic Umbilical Cord Mesenchymal Stem Cells" in Patients Referred to Dr. Shariati Hospital in 2023

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221009056121N1
Enrollment
20
Registered
2022-12-10
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

Scaphoid Non-union. Unspecified fracture of navicular [scaphoid] bone of unspecified wrist, subsequent encounter for fracture with nonunion

Interventions

Intervention 1: Intervention group: nonunion of the scaphoid bone undergoes internal fixation and allogeneic mesenchymal stem cells of umbilical cord origin implanted in fibrin gel are used to induce

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Having Scaphoid 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 Wrist Wrist Osteoarthritis Presence of Accompanying Injury (Fracture in Other Bones of the Wrist)

Design outcomes

Primary

MeasureTime frame
Union of Scaphoid Bone. Timepoint: 3, 6, 9, 12, 24, and 48 Months After Surgery. Method of measurement: Antero-posterior and Lateral Radiography of the Wrist.

Secondary

MeasureTime 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: Qiuck-DASH (Disabilities of the Arm, Shoulder, and Hand score).;Time to Union. Timepoint: 3, 6, 9, 12, 24, 48 and 96 Months After Surgery. Method of measurement: Week.;Grip Strength. Timepoint: 3, 6, 9, 12, 24, 48 and 96 Months After Surgery. Method of measurement: Jamar Dynamometer.;Wrist 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