Repair of bone fractures with scaffold and stem cells

Investigation effects and safety of collagen scaffold reinforced with polyglycolic acid and mesenchymal stem cells harvested from the iliac crest in comparison with the iliac bone graft on the healing process of scaphoid fractures in young male patients (20 to 30 years)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20181222042074N1

Enrollment

Registered

2020-09-03

Start date

2019-04-06

Completion date

Unknown

Last updated

2020-09-07

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

Conditions

non-union scaphoid fracture.

Interventions

Intervention 1: The control group: gets standard treatment with placement of iliac bone graft in site of non-union. Intervention 2: Intervention group: Collagen / Polyglycolic acid scaffold with a wei

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: All patients with non-union fractures in Scaphoid bone Age between 18 and 60 years old No infection at the fracture site Patient availability for postoperative examinations Fill conscious awareness Individuals who want to refer for postoperative follow-up

Exclusion criteria

Exclusion criteria: Patients with other diseases, such as cancer. Patients with other associated motor injuries preventing normal ability. patients with infectious non-union fracture. Pregnant patients Patients have a positive HIV-positive serology or hepatitis B and C.

Design outcomes

Primary

Measure	Time frame
The rate of bone formation. Timepoint: Before the intervention and 1, 3 and 6 months after surgery. Method of measurement: 1-Quick DASH, PRWE, Wrist Mayo Clinic 2- Flexion, Extension, Supination, Pronation, Ulnar & radial deviations 3- CT scan before and after surgery 4-Radiography.;The rate of callus tissue formation. Timepoint: Before the intervention and 1, 3 and 6 months after surgery. Method of measurement: Radiographs and CT scans.	—

Measure

Time frame

The rate of bone formation. Timepoint: Before the intervention and 1, 3 and 6 months after surgery. Method of measurement: 1-Quick DASH, PRWE, Wrist Mayo Clinic 2- Flexion, Extension, Supination, Pronation, Ulnar & radial deviations 3- CT scan before and after surgery 4-Radiography.;The rate of callus tissue formation. Timepoint: Before the intervention and 1, 3 and 6 months after surgery. Method of measurement: Radiographs and CT scans.

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Secondary

Measure	Time frame
Time duration of union. Timepoint: 2 weeks, 3 months and 6 months after intervention. Method of measurement: Days, X-ray, physical examination.;Nonunion. Timepoint: 6 months after intervention. Method of measurement: X-Ray, physical examination.;Surgical site infection. Timepoint: 2 days, 2 weeks, 3 months after intervention. Method of measurement: physical examination, ESR and CRP lab tests.;Duration of anesthesia. Timepoint: at the time of operation in operating room. Method of measurement: inspection.;Pain. Timepoint: before, 3 and 6 months after surgery. Method of measurement: Visual Analog Scale (VAS).;Function. Timepoint: before, 3 and 6 months after surgery. Method of measurement: Lower Extremity Functional Score (LEFS).	—

Measure

Time frame

Time duration of union. Timepoint: 2 weeks, 3 months and 6 months after intervention. Method of measurement: Days, X-ray, physical examination.;Nonunion. Timepoint: 6 months after intervention. Method of measurement: X-Ray, physical examination.;Surgical site infection. Timepoint: 2 days, 2 weeks, 3 months after intervention. Method of measurement: physical examination, ESR and CRP lab tests.;Duration of anesthesia. Timepoint: at the time of operation in operating room. Method of measurement: inspection.;Pain. Timepoint: before, 3 and 6 months after surgery. Method of measurement: Visual Analog Scale (VAS).;Function. Timepoint: before, 3 and 6 months after surgery. Method of measurement: Lower Extremity Functional Score (LEFS).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShirin Toosi

Mashhad University of Medical Sciences

tusi1063@gmail.com+98 51 3882 3255

Outcome results

None listed

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