A study to assess the use and effectiveness of GEMOS2 in achieving early bone formation and healing of distal radius fractures.
- Conditions
- distal radius fracturesMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12608000052336
- Lead Sponsor
- BioMimetics Therapeutics Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method