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

NCT04200872 | Completed

• 1 other identifier: PAAS
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudarthrosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

biological adjuvants

patients with aseptic pseudarthrosis clinically treated with biological adjuvants

Other: biological adjuvants

without biological adjuvants

patients with aseptic pseudarthrosis clinically treated without biological adjuvants

Other: no biological adjuvants

Interventions

biological adjuvants OTHER

patients with aseptic pseudarthrosis clinically treated with biological adjuvants

biological adjuvants

no biological adjuvants OTHER

patients with aseptic pseudarthrosis clinically treated without biological adjuvants

without biological adjuvants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients surgically treated from 2000 to 2017 at the Innovative Techniques Orthopedic Surgery - Musculoskeletal Tissue Bank (BTM) of the Istituto Ortopedico Rizzoli for pseudoarthrosis of the upper limb (with or without biological adjuvants)

You may qualify if:

• 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

You may not qualify if:

• Pseudoarthrosis due to pathological fracture
• Infected pseudarthrosis
• Pseudoarthrosis treated with external fixation
• BMI\> 35

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Italy

Location

Related Publications (2)

• Krishnakumar GS, Roffi A, Reale D, Kon E, Filardo G. Clinical application of bone morphogenetic proteins for bone healing: a systematic review. Int Orthop. 2017 Jun;41(6):1073-1083. doi: 10.1007/s00264-017-3471-9. Epub 2017 Apr 19.

  PMID: 28424852 BACKGROUND

• Dallari D, Savarino L, Stagni C, Cenni E, Cenacchi A, Fornasari PM, Albisinni U, Rimondi E, Baldini N, Giunti A. Enhanced tibial osteotomy healing with use of bone grafts supplemented with platelet gel or platelet gel and bone marrow stromal cells. J Bone Joint Surg Am. 2007 Nov;89(11):2413-20. doi: 10.2106/JBJS.F.01026.

  PMID: 17974883 BACKGROUND

MeSH Terms

Conditions

Pseudarthrosis

Condition Hierarchy (Ancestors)

Fractures, Ununited; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 16, 2019
• Study Start: November 4, 2019
• Primary Completion: May 4, 2020
• Study Completion: May 4, 2020
• Last Updated: May 23, 2023

Record last verified: 2019-11

Locations

IT (1)