An observational study in Pseudarthrosis, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-23.
Sponsored by Istituto Ortopedico Rizzoli · Observational
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.
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
41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.
This study's enrollment of 90 is above the median of 60 across 16 observational studies indexed under Pseudarthrosis.
Browse Pseudarthrosis studies →Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients with aseptic pseudarthrosis clinically treated with biological adjuvants
Other: biological adjuvants
patients with aseptic pseudarthrosis clinically treated without biological adjuvants
Other: no biological adjuvants
patients with aseptic pseudarthrosis clinically treated with biological adjuvants
patients with aseptic pseudarthrosis clinically treated without biological adjuvants
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.
Time frame: 12 months
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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