Clinical Trials Directory

Trials / Completed

CompletedNCT04200872

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
Phase
Study type
Observational
Enrollment
90 (actual)
Sponsor
Istituto Ortopedico Rizzoli · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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

Conditions

Interventions

TypeNameDescription
OTHERbiological adjuvantspatients with aseptic pseudarthrosis clinically treated with biological adjuvants
OTHERno biological adjuvantspatients with aseptic pseudarthrosis clinically treated without biological adjuvants

Timeline

Start date
2019-11-04
Primary completion
2020-05-04
Completion
2020-05-04
First posted
2019-12-16
Last updated
2023-05-23

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04200872. Inclusion in this directory is not an endorsement.