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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04200872

Enrollment

Registered

2019-12-16

Start date

2019-11-04

Completion date

2020-05-04

Last updated

2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudarthrosis

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

Interventions

OTHERbiological adjuvants

patients with aseptic pseudarthrosis clinically treated with biological adjuvants

OTHERno biological adjuvants

patients with aseptic pseudarthrosis clinically treated without biological adjuvants

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Pseudoarthrosis Radiographic Healing Score (PRHS)	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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026