None listed
Conditions
Brief summary
This is a prospective, randomised, controlled pilot study to evaluate the safety and clinical utility (i.e., performance, functional radiographic parameters) of Graftys(R)HBS or Graftys(R)Quickset in the treatment of unstable distal radius fractures, when used with fractures treated by Kirschner wire fixation. The study will enroll a minimum of 10 patients to a maximum of 50 patients per arm requiring treatment of a primary unstable distal radius fracture.
Interventions
The study device, Graftys(R)HBS or Graftys(R)Quickset, is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute.
Both of them demonstrate approximately 65-70% total porosity, of which about 8% is macroporosity (pore size from 100 to 300 microns).
Graftys(R)HBS is a low viscosity cement that has a longer setting time and a lower compressive strength but which can be applied through a narrow gauge cannula. Graftys(R)Quickset has a highly viscosity and shorter settin
The study device, Graftys(R)HBS or Graftys(R)Quickset, is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. Both of them demonstrate approximately 65-70% total porosity, of which about 8% is macroporosity (pore size from 100 to 300 microns). Graftys(R)HBS is a low viscosity cement that has a longer setting time and a lower compressive strength but which can be applied through a narrow gauge cannula. Graftys(R)Quickset has a highly viscosity and shorter setting time This is a prospective, randomised, controlled pilot study to evaluate the safety and clinical utility (i.e., performance, functional radiographic parameters) of Graftys(R)HBS or Graftys(R)Quickset in the treatment of unstable distal radius fractures. All enrolled subjects will be treated by percutaneous reduction, minimally invasive or noninvasive fixation techniques, including casting, external fixation, external fixation with percutaneous pins, percutaneous pins or screws with cast or percutaneous pins with cast. The resulting bone void will be grafted with Graftys(R)HBS (Arm 1), Graftys(R)Quickset (Arm 2) or no bone void filler (Arm 3), when assigned by the randomization schema. The graft material will be implanted percutaneously or manually packed into the fracture space, dependent upon the method of fixation, prior to, during, or following reduction and fixation and stabilisation of the fracture. The graft material will be constructed to fill comminuted fracture spaces via interdigitation within comminuted cancellous bone, both dorsally, distally and proximally. The degree of fill required may vary from less than 2mm to as much as 2cm depending on the amount of bone involved. When implanted, the graft material may prevent the collapse of a fracture caused by compressive forces generated by the muscle tendon units crossing the fracture site. The procedure time will vary depending on time taken to achieve an adequate reduction of the fracture.
Sponsors
Austofix
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
1. Patient has signed the FCREC approved Informed Consent Form specific to this study prior to enrollment, and are willing to participate in the length of the study including prescribed follow-ups. 2. The patient has an unstable, unilateral, extra-articular distal radius fracture which is widely displaced with extensive dorsal comminution, dorsal angulation greater than 20 degrees. Avulsed ulnar styloid tip is allowed. 3. Patient’s fracture is able to be manually reduced in a single attempt up to 2 weeks post injury. 4. Patient is independent, ambulatory, and can comply with all post-treatment evaluations and visits. 5. Patient is skeletally mature and =18 years of age. 6. The distal radius fracture does not require structural bone graft. 7. Patient has Colles fracture (extra-articular fracture)
Exclusion criteria
1. Patient has suffered a previous wrist fracture on the affected wrist or contralateral wrist within the previous 12 months of the current fracture date. 2. Patient’s fracture meets any of the following criteria: Bilateral distal radius fractures or clinically significant injury to the contralateral limb. Severe comminution involving the diaphysis of the radius and/or radioulnar joint. Ulnar fracture (AO: A1.1, A1.2, and A1.3)/Ulnar styloid. Presence of pre-operative hard or soft tissue infection at the operative site. Requires supplemental internal fixation for adequate reduction (e.g. plates) Open fractures Closed head injuries Intra-articular fracture with diastasis of the subchondral bone. 3. Patient is currently undergoing radiotherapy or chemotherapy. 4. Patient has a metabolic disorder known to adversely affect the skeleton, other than primary osteoporosis (e.g., renal osteodystrophy) 5. Patient uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day). Note: NSAID use is excluded during the first 6 weeks post-treatment. 6. Patient has a clotting disorder or uses anticoagulant therapy (e.g., coumadin). Antiplatelet therapy is acceptable for daily cardiovascular maintenance. 7. Patient has a Smith fracture.
Outcome results
None listed