Barbier 2008.
Trial name or title | Allomatrix injectable putty in distal radius fractures |
Methods | |
Participants | 50 patients with unstable fractures of the distal radius. Inclusion: age 18 to 70 years, unstable distal radius fracture (types I, III and IV (Fernandez)), informed consent. Exclusion: Associated traumatic lesions, associated severe pathological conditions, pregnancy. |
Interventions | After surgical reduction and stabilisation with percutaneous pinning alone or with external fixation bridging the joint: (1) ALLOMATRIX injectable putty; (2) no additional graft. |
Outcomes | Follow up: 1 year.
Primary outcome measures: hand ability: self‐assessment questionnaire ABILHAND and DASH.
Secondary Outcome Measures: Bone mineral density, radiological evaluation, hand impairment (strength, sensibility, mobility) Also, failure (non‐union, malunion, fracture instability, wrist stiffness) and complication (infection, drainage, hardware failure, wound dehiscence) rates. |
Starting date | Start date: June 2005 Completion: June 2008 |
Contact information | Dr Olivier Barbier, MD Cliniques Universitaires St‐Luc Brussels 1200 Belgium Tel: + 32 2 7641111 Ext. 2523 E‐mail:olivier.barbier@orto.ucl.ac.be |
Notes | At the end of the surgical reduction and stabilization of the fracture, the sequentially numbered randomization envelope will be opened and the patient will receive the treatment listed within the envelope. |
DASH: Disability of the Arm, Shoulder, and Hand questionnaire