Volar Plate vs. Conventus DRS Fixation

Completed · Not applicable

Conditions studied: Fractures, Closed

In brief

Open reduction and internal fixation (ORIF) of unstable distal radius fractures is performed using a variety of fixation techniques. The most common method is fixed angle volar plate application. The investigators plan to compare the outcomes of fixed angle volar plating with a novel FDA approved intramedullary fixation device, Conventus DRS.

Key facts

Study ID

NCT02390856

Run by

Hospital for Special Surgery, New York

People needed

12

Starts

2015-02-01

Expected to finish

2018-12-01

Last updated by the study team

2019-02-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Skeletally mature patients (18-80)
• Unstable AO Type A and C1 fractures
• Closed injuries, acute (<14 days), displaced, and unstable

You may not qualify if…

• Patients under the age of 18 or over the age of 85 (if included in our analysis, these would likely be outliers in our patient population)
• Patients with documented complex regional pain syndrome (CRPS) or history of CRPS
• Patients with suspected or known allergies to titanium or nickel
• Patients who are non-English speakers
• Patients with open wound fractures
• Patients with inflammatory arthritis
• Patients with positive pregnancy test
• Additional musculo-skeletal injuries of the upper extremity would represent exclusion criteria (elbow fractures, scaphoid fractures, and contralateral wrist fracture).
• Previous major wrist injury or surgery (not including Carpal Tunnel, De Quervain's and trigger finger release)
• Patients with previously diagnosed metabolic bone disease, currently being treated.
• Non-English speaking patients (validated, translated questionnaires are not available)
• Patients needing ipsilateral concomitant operations that will have material impact on the study
• Patients with previous wrist fractures, prior wrist injury, stiffness, degenerative joint disease, or pain
• Previous minor surgery - for carpal tunnel, de Quervain's, ganglion, etc. - does not constitute exclusion criteria

Where it is running

• Hospital for Special Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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