None listed
Conditions
Interventions
GEM OS2 is applied to the bone void(s) and is contained within the fracture void(s) it physically fills bone defects providing a biocompatible, osteoconductive scaffold for new bone formation and promoting
cellular ingrowth into the osseous defect.
This device is composed of two components: a beta
tricalcium phosphate (ß-TCP) / collagen matrix, and becaplermin, which is a highly purified recombinant human platelet-derived growth factor (rhPDGF-BB).-derived growth factor (rhPDGF-BB). The GEM OS2
GEM OS2 is applied to the bone void(s) and is contained within the fracture void(s) it physically fills bone defects providing a biocompatible, osteoconductive scaffold for new bone formation and promoting cellular ingrowth into the osseous defect. This device is composed of two components: a beta tricalcium phosphate (ß-TCP) / collagen matrix, and becaplermin, which is a highly purified recombinant human platelet-derived growth factor (rhPDGF-BB).-derived growth factor (rhPDGF-BB). The GEM OS2 device is supplied as a single use kit, with sterile individual components of ß- TCP/collagen matrix and a separate syringe containing a solution of rhPDGF-BB (becaplermin). At the time of surgery, the clinician fully saturates the ß-TCP/collagen matrix with the rhPDGF BB solution. After mixing, the hydrated graft will have a putty consistency which may be injected percutaneously, or manually packed into the osseous defect dependent on the method of fixation. As this device is surgically implanted it will remain and be taken up by the body as the fracture heals. The GEM OS2 device is supplied as a two component kit. Each kit consists of: one (1) “brick” containing 3 cc of b-TCP/ collagen; and, one (1) syringe containing 3 mL solution of 0.3 mg/ml rhPDGF-BB (becaplermin) in sodium acetate buffer. When combined there is a total of 0.9 mg rhPDGF-BB in the 3 mL that may be implanted at the fracture site. It has been estimated that each patient will receive approximately 1mL at minimum and no more than 3 mL at maximum which equates to 0.3mg rhPDGF-BB at minimum and no more than 0.9mg rhPDGF-BB at maximum.
Sponsors
BioMimetics Therapeutics Inc
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 No maximum
Healthy volunteers
No
Inclusion criteria
Subjects who meet the following criteria may be included in the study if they present with all of the following: 1) The subject has signed the Independent Ethics Committee (IEC) approved Informed Consent Form specific to this study prior to enrollment 2) The subject has an unstable unilateral, extraarticular distal radius fracture classified as unstable with the following radiographic findings: wide displacement requiring reduction defined as >10° or 20° volar tilt or instability defined as 20° dorsal tilt; or an intraarticular fracture that is amenable to external-fixation or closed fracture reduction. Avulsed ulnar styloid tip is allowed 3) The subject’s fracture is able to be manually reduced in a single attempt up to 2 weeks post injury 4) The subject is independent, ambulatory, and can comply with all post-treatment evaluations and visits 5) The subject is skeletally mature and =18 years of age 6) The distal radius fracture does not require structural bone graft.
Exclusion criteria
Subjects will be excluded from the study if they present with any of the following: 1) The subject has suffered a previous wrist fracture on the affected wrist or contralateral wrist within the previous 12 months of the current fracture date 2) The subject’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) • 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) The subject is currently undergoing radiotherapy or chemotherapy 4) The subject has a metabolic disorder known to adversely affect the skeleton, other than primary osteoporosis (e.g., renal osteodystrophy) 5) The subject 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) The subject has a clotting disorder or uses anticoagulant therapy (e.g., coumadin). Antiplatelet therapy is acceptable for daily cardiovascular maintenance 7) The subject has a pre-fracture neuromuscular or musculoskeletal deficiency which limits the ability to perform objective functional measurements 8) The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, etc.) 9) The subject has an allergy to yeast-derived products 10) Allergy to bovine collagen and/or to other bovine source medication, supplements or products 11) The subject is enrolled in another device or drug investigational study (currently or within the past 30 days of surgery or during the follow-up phase of this study) 12) The subject is a prisoner, is known or suspected to be transient, or has a history of drug/alcohol abuse (as determined by investigator) within the 12 months prior to screening for study entry 13) The subject is pregnant or a female intending to become pregnant during this study period.
Outcome results
None listed