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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04200872
Other study ID # PAAS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 4, 2019
Est. completion date May 4, 2020

Study information

Verified date November 2019
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to collect boh clinical and radiographic data coming from the treated patients for pseudarthrosis of the upper limbs from 2000 to 2017 at the SC Orthopedic Surgery, Innovative Techniques of the Istituto Ortopedico Rizzoli in order to evaluate the clinical and radiographic outcomes of the treatment, with or without the application of biological adjuvants.


Description:

The bone healing requires the integrations of two main principles: biomechanical aspect and biological aspect. The second one has having growing interest. The use of the biological adjuvants, as growth factors (rhBMP2 and 7), platelet-derived growth factors (PDGFs), Platelet gel (PG) or Plasma Rich Fibrin (PRF), as well as peptides and molecules are demonstrating promising results in the field of bone regeneration. The addition of autologous bone marrow concentrate cells has proven to be an effective option in the treatment of bone defects, although to date there is no clear superiority of one method over the other. In light of this, the purpose of the study is to evaluate the clinical and radiographic outcomes of the treatment, with or without the application of biological adjuvants, collecting data coming from the treated patients for pseudarthrosis of the upper limbs from 2000 to 2017 at the SC Orthopedic Surgery, Innovative Techniques of the Istituto Ortopedico Rizzoli


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 4, 2020
Est. primary completion date May 4, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with post-traumatic pseudoarthrosis of the long bones of the upper limb - Duration of at least 6-9 months without clinical-radiographic signs of healing in the 3 months prior to pseudoarthroses Exclusion Criteria: - Pseudoarthrosis due to pathological fracture - Infected pseudarthrosis - Pseudoarthrosis treated with external fixation - BMI> 35

Study Design


Related Conditions & MeSH terms


Intervention

Other:
biological adjuvants
patients with aseptic pseudarthrosis clinically treated with biological adjuvants
no biological adjuvants
patients with aseptic pseudarthrosis clinically treated without biological adjuvants

Locations

Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Dallari D, Savarino L, Stagni C, Cenni E, Cenacchi A, Fornasari PM, Albisinni U, Rimondi E, Baldini N, Giunti A. Enhanced tibial osteotomy healing with use of bone grafts supplemented with platelet gel or platelet gel and bone marrow stromal cells. J Bone Joint Surg Am. 2007 Nov;89(11):2413-20. doi: 10.2106/JBJS.F.01026. — View Citation

Krishnakumar GS, Roffi A, Reale D, Kon E, Filardo G. Clinical application of bone morphogenetic proteins for bone healing: a systematic review. Int Orthop. 2017 Jun;41(6):1073-1083. doi: 10.1007/s00264-017-3471-9. Epub 2017 Apr 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pseudoarthrosis Radiographic Healing Score (PRHS) Numeric score rapresenting presence or absence of bone callus. The score range from 0 to 4, with 0 score rapresent absence of bone callus and no bone graft integration, and 4 presence of bone callus and completed bone graft integration. 12 months
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