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

Completed

• Conditions: Pseudarthrosis
• Interventions: Other: biological adjuvants; Other: no biological adjuvants

• Registration Number: NCT04200872
• Lead Sponsor: Istituto Ortopedico Rizzoli

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

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-04
• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-16
• Primary Completion: 2020-05-04
• Study Completion: 2020-05-04
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
biological adjuvants	biological adjuvants	patients with aseptic pseudarthrosis clinically treated with biological adjuvants
without biological adjuvants	no biological adjuvants	patients with aseptic pseudarthrosis clinically treated without biological adjuvants

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy