Observational Retrospective Study on the Clinical and Radiographic Outcomes of the Aseptic Pseudarthrosis Treatment of the Upper Limb

Pseudarthrosis Clinical Trial

Official title:

Retrospective Study on the Clinical Outcomes of the Aseptic Pseudarthrosis Treatment of the Upper Limb

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04200872
• Other study ID #: PAAS
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Pseudarthrosis

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