Clinical trial NCT04200872: Observational Retrospective Study on the Clinical and Radiographic Outcomes of the Aseptic Pseudarthrosis Treatment of the Upper Limb
Official title: Retrospective Study on the Clinical Outcomes of the Aseptic Pseudarthrosis Treatment of the Upper Limb
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudarthrosis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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

Eligibility criteria: 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

Primary outcomes:
measure: Pseudoarthrosis Radiographic Healing Score (PRHS)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: 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.
citation: 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.