Retrospective Study on the Clinical Outcomes of the Aseptic Pseudarthrosis Treatment of the Upper Limb
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pseudarthrosis
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Pseudoarthrosis Radiographic Healing Score (PRHS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Pseudoarthrosis Radiographic Healing Score (PRHS)
Time Frame: 12 months
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.