Clinical Trial: Allomatrix Injectable Putty in Distal Radius Fractures

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Allomatrix Injectable Putty in Distal Radius Fractures. Protocol for a Randomised, Controlled Clinical Study in Unstable Fractures of the Distal Radius

Brief Summary:

Allomatrix is a combination of Demineralized Bone Matrix with a binding medium of calcium sulfate hemihydrate and carboxymethylcellulose. Allomatrix combines the osteoinductive capacity of DBM with the osteoconduction and controlled resorption of surgical grade calcium sulfate.

Unstable fractures of the distal radius do not resist displacement once it has been manipulated into an anatomical position.

There is a parallel between the quality of the anatomic result and the residual capacity of the wrist, except in older, low demanding patients.

Injectable osteoconductive cements have been introduced to fill voids in metaphyseal bone and may provide a better stability around hardware in osteoporotic bone and help maintain reduction of fracture fragments.Moreover, a product like ALLOMATRIX could accelerate and improve bone healing and fracture stability by its osteoinductive properties. However, the clinical significance of these new bone graft materials still have to be proven in a randomised controlled study set-up.


Detailed Summary:

STUDY DESIGN

The study is designed as a randomised, prospective, study with concurrent control. A total of 50 patients will be enrolled by one centre and will be randomised into two groups. One group of patients (comprising 50% of the study population) will have ALLOMATRIX Injectable Putty implanted. In a control group of patients (comprising 50% of the study population as well ) no graft material will be used.

Patients will be randomly assigned to one of the two treatment arms. Sequentially numbered randomisation envelopes will be provided. Once the surgical reduction and stabilisation has been completed, the next sequentially numbered randomisation envelope will be opened and the patient will receive the treatment listed within the envelope. Each envelope will contain one of the treatment arms based on a computer generated randomised schedule.

DURATION AND ENDPOINTS OF THE STUDY The enrollment period is expected to be about 3 years. Patients will be followed from a pre-operative visit through a one-year visit.

Study End Points:

  • Comparison of time to healing of the fracture
  • Comparison of function of operated wrist
  • Radiographic and densitometric assessment of bone regeneration
  • Failure rates (Non-union, malunion, fracture instability, wrist stiffness)
  • Complication rates (infection, drainage, hardware failure, wound dehiscence)
  • Bone growth factors (on blood samples from both forearms at 3 weeks after surgery)

PATIENT S
Sponsor: Université Catholique de Louvain

Current Primary Outcome: Hand ability: self-assesment questionnaire ABILHAND and DASH

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bone mineral density
  • Radiological evaluation
  • Hand impairment (strength, sensibilty, mobility)


Original Secondary Outcome: Same as current

Information By: Université Catholique de Louvain

Dates:
Date Received: January 6, 2006
Date Started: June 2005
Date Completion:
Last Updated: July 29, 2009
Last Verified: July 2009