A Prospective, Randomized, Controlled, Pilot Clinical Study to Evaluate Graftys(R)HBS or Graftys(R)QUICKSET for the Treatment of Unstable Distal Radius Fractures

Austofix0 个研究点目标入组 50 人开始时间: 2010年11月16日最近更新: 2020年1月13日

适应症

试验速览

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•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)

•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.

发起方

Austofix