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IRCT20181222042074N1 IRCT 2020-09-03 Mashhad University of Medical Sciences 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) 2019-04-06 anticipated 10 Complete https://irct.ir/trial/36219 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 non-union scaphoid fracture. 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 weight ratio of 0.5 prepare. Bone marrow aspiration from the iliac crest is performed with a Jamshidi needle under local anesthesia, and the mesenchymal stem cells (MSCs) taken from each individual are transferred to a laboratory and cultured in the clean room. The cell will be used in passage 1, then MSCs seed into sponge and will be placed during surgery into scaphoid fracture. The healing process is assessed 1,3 and 6 months after surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Shirin Toosi
Biotechnology Research Center, School of Pharmacy, Ferdowci University, Park Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9188617871 +98 51 3882 3255 tusi1063@gmail.com Mashhad University of Medical Sciences scientific Javad Behravan
Biotechnology Research Center, School of Pharmacy, Ferdowci University, Park Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9188617871 +98 51 3882 3255 behravanj@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 18 years 60 years Both 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. Treatment - Devices Treatment - Devices The control group: gets standard treatment with placement of iliac bone graft in site of non-union. Intervention group: Collagen / Polyglycolic acid scaffold with a weight ratio of 0.5 prepare. Bone marrow aspiration from the iliac crest is performed with a Jamshidi needle under local anesthesia, and the mesenchymal stem cells (MSCs) taken from each individual are transferred to a laboratory and cultured in the clean room. The cell will be used in passage 1, then MSCs seed into sponge and will be placed during surgery into scaphoid fracture. The healing process is assessed 1,3 and 6 months after surgery. 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. 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). Mashhad University of Medical Sciences Approved 2017-04-16 The Ethics committee of vice chancellor of research Mashhad University of Medical Sciences Central building of Mashhad University of Medical Sciences (Qoreishi), Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)