A prospective, multi-center (up to 4 sites), single-arm, study of 20 subjects. Patient enrollment will consist of subjects with an AO/OTA type 2R3C distal radius fracture. Enrollment will be prospectively stratified based on patient age (Stratum A: \<65 and Stratum B: ≥65 years)
The proposed study design is prospective, multi-center, single-arm, and non-randomized. RevBio is working to establish up to four (4) clinical sites. RevBio will perform site initiation visits to provide training to the investigator and its staff. Training will include information about study-specific procedures, a detailed review of the study protocol, instruction in completion of the electronic case report forms (eCRFs), informing the site about device instructions for use, and discussion of the regulatory requirements of the investigator. Patients will be recruited from the general patient population based on inclusion/exclusion criteria. Once they sign the informed consent form and complete the screening process they will be enrolled in the study and scheduled for surgery. All data will be reported to the FDA to evidence safety and efficacy and substantiate advancing to future stages in a larger expanded study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Participants will receive typical standard of care treatment for AO/OTA type 2R3C distal radius fractures augmented with tetranite bone adhesive.
Safety based on the rate of serious device related adverse events
Safety based on the rate of serious device related adverse events
Time frame: For 52 weeks following surgery
Efficacy based on the fracture union assessment at the 26-week follow-up
Fracture union assessment at the 26-week follow-up
Time frame: 26 weeks
Efficacy based on the DASH assessment at the 26-week timepoint
DASH assessment at the 26-week timepoint
Time frame: 26 weeks
Grip strength compared to baseline (contralateral limb)
Grip strength compared to baseline (contralateral limb)
Time frame: 6 weeks post surgery to 52 weeks post surgery
Range of motion compared to baseline (contralateral limb)
Range of motion compared to baseline (contralateral limb)
Time frame: 2 weeks post surgery to 52 weeks post surgery
Patient reported outcome measure: SF-36
Patient reported outcome measures: SF-36
Time frame: 2 weeks post surgery to 52 weeks post surgery
Patient reported outcome measure: DASH
Patient reported outcome measure: DASH
Time frame: 2 weeks post surgery to 52 weeks post surgery
Patient reported outcome measure: VAS Pain Score
Patient reported outcome measure: VAS Pain Score
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Time frame: 2 weeks post surgery to 52 weeks post surgery
Maintenance of reduction compared to baseline (surgery)
Maintenance of reduction compared to baseline (surgery)
Time frame: Surgery
Fracture union assessment at the 6-,12-week follow-ups
Fracture union assessment at the 6-,12-week follow-ups
Time frame: 6-,12-week follow-ups