Allomatrix Injectable Putty in Distal Radius Fractures

NCT00274378 | Completed Phase 4

• 1 other identifier: Allomatrix radius UCL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Radius Fractures

Keywords

radius fracture; fracture fixation; homologous bone transplantation

Outcome Measures

Primary Outcomes (1)

• Hand ability: self-assesment questionnaire ABILHAND and DASH

Secondary Outcomes (3)

• Bone mineral density

• Radiological evaluation

• Hand impairment (strength, sensibilty, mobility)

Interventions

ALLOMATRIX injectable putty in distal radius fractures DEVICE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unstable distal radius fracture

You may not qualify if:

• associated traumatic lesions
• associated severe pathological conditions
• pregnancy

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• Stryker Trauma and Extremities: collaborator

Study Sites (1)

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

Related Publications (4)

• Cassidy C, Jupiter JB, Cohen M, Delli-Santi M, Fennell C, Leinberry C, Husband J, Ladd A, Seitz WR, Constanz B. Norian SRS cement compared with conventional fixation in distal radial fractures. A randomized study. J Bone Joint Surg Am. 2003 Nov;85(11):2127-37. doi: 10.2106/00004623-200311000-00010.

  PMID: 14630841 BACKGROUND

• Barbier O, Penta M, Thonnard JL. Outcome evaluation of the hand and wrist according to the International Classification of Functioning, Disability, and Health. Hand Clin. 2003 Aug;19(3):371-8, vii. doi: 10.1016/s0749-0712(02)00150-6.

  PMID: 12945633 BACKGROUND

• Lafontaine M, Hardy D, Delince P. Stability assessment of distal radius fractures. Injury. 1989 Jul;20(4):208-10. doi: 10.1016/0020-1383(89)90113-7.

  PMID: 2592094 BACKGROUND

• Hollevoet N, Verdonk R. Outcome of distal radius fractures in relation to bone mineral density. Acta Orthop Belg. 2003 Dec;69(6):510-4.

  PMID: 14748106 BACKGROUND

MeSH Terms

Conditions

Radius Fractures

Condition Hierarchy (Ancestors)

Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Olivier BARBIER, MD

  Cliniques Universitaires St-LUC, 1200 Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2006
• First Posted: January 10, 2006
• Study Start: June 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 30, 2009

Record last verified: 2009-07

Locations

BE (1)