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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pseudarthrosis

Intervention / Treatment
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* Other: biological adjuvants
* Other: no biological adjuvants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| biological adjuvants<br>patients with aseptic pseudarthrosis clinically treated with biological adjuvants | Other: biological adjuvants<br>* patients with aseptic pseudarthrosis clinically treated with biological adjuvants<br>|
| without biological adjuvants<br>patients with aseptic pseudarthrosis clinically treated without biological adjuvants | Other: no biological adjuvants<br>* patients with aseptic pseudarthrosis clinically treated without biological adjuvants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |