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NCT Number: NCT04200872

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

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.

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Key information

Conditions

Pseudarthrosis Fractures, Bone Fractures, Ununited Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, Italy

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biological adjuvants

Other

patients with aseptic pseudarthrosis clinically treated with biological adjuvants

no biological adjuvants

Other

patients with aseptic pseudarthrosis clinically treated without biological adjuvants

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 16, 2019
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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