Clinical Trial: Volar Plate vs. Conventus DRS Fixation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized Controlled Trial: Volar Plate vs. Conventus DRS Intramedullary Fixation for Distal Radius Fractures

Brief Summary: 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.

Detailed Summary:

Distal radius fractures are the most common fractures in the upper extremity. While a widely used method of fracture fixation, numerous studies have shown that locked volar plate fixation is associated with soft tissue irritation, flexor and extensor tendon rupture, and screw penetration of the radiocarpal or the distal radioulnar joint (DRUJ). Prominent hardware mandates hardware removal in 5-18% of cases.

Intramedullary fixation has recently received more attention in the literature because of the minimally invasive procedure required for device implantation. Additionally, because intramedullary fixation places the implant within the bone instead of onto it, the lack of implant exposure, as well as decreased soft tissue dissection, carries the potential for decreased inflammation at the surgical site. This prospective randomized case series will evaluate the clinical and functional outcomes of an expandable intramedullary fixation device and compare the complication profile with traditional fixed angle volar locked plating in a single-surgeon case series at a single hospital.

The wide variety of distal radius fractures demand customized treatment, and a number of different surgical treatments methods are available.(1) While percutaneous/external fixation, dorsal plating, fragment specific fixation, and intramedullary rod fixation have been studied, volar locked plate fixation has emerged over the past decade as the most common and versatile method of fracture fixation. Unfortunately, soft tissue and hardware complications continue to plague volar plate fixation, including digital stiffness, loss of forearm rotation, tendinopathy and tendon rupture, nerve injury and compression, hardware irritation, screw prominence, CRPS, and malunion.

Tarallo et al performed a retrospect
Sponsor: Hospital for Special Surgery, New York

Current Primary Outcome:

  • Change from Baseline in Complications at 2 weeks [ Time Frame: 2 weeks ]

    Patients will be followed for up to one year after surgery to assess any complications which may develop. Complications will be defined as:

    • Stiffness (defined as inability to touch fingertips to distal palmar crease, OR 45 degrees or more loss of supination or pronation [compared to uninjured wrist], OR BOTH)
    • Loss of reduction
    • Hardware breakage
    • Hardware removal
    • Return to OR
    • Tendinopathy
    • Tendon rupture
    • Neuropathy
    • Superficial infection
    • Deep infection
    • Wound dehiscence
    • Incisional pain
    • Chronic Regional Pain Syndrome (CRPS)
  • Change from Baseline in Complications at 6 weeks [ Time Frame: 6 weeks ]

    Patients will be followed for up to one year after surgery to assess any complications which may develop. Complications will be defined as:

    • Stiffness (defined as inability to touch fingertips to distal palmar crease, OR 45 degrees or more loss of supination or pronation [compared to uninjured wrist], OR BOTH)
    • Loss of reduction
    • Ha

      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • Wrist Range of Motion [ Time Frame: Up to 1 year ]
        Patients will be followed for up to one year after surgery to assess wrist motion (measurements of flexion, extension, radial deviation, ulnar deviation pronation, and supination)
      • Visual Analog Pain (VAS) Score [ Time Frame: Up to 1 year ]
        VAS scores (0-10) will be obtained at standard clinical follow-up up to 1 year, after the scale of 0-10 (no pain - worst pain) has been explained
      • Patient-Rated Wrist Evaluation (PRWE) questionnaire [ Time Frame: Up to 1 year ]
        The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. It will be administered at clinical follow-ups up to 1 year after surgery at 2 weeks, 6 weeks, 3 months, and 1 year postoperatively.
      • Tourniquet time [ Time Frame: Time of Surgery ]
        On one occasion, on the day of surgery, tourniquet time will be recorded in minutes.
      • Operative time [ Time Frame: Time of Surgery ]
        On one occasion, on the day of surgery, operative time will be recorded in minutes.
      • Articular Step off [ Time Frame: Up to 1 year ]
        Articular step off will be assessed on x-rays at clinical follow-ups up to 1 year after surgery at 2 weeks, 6 weeks, 3 months, and 1 year postoperatively.
      • Articular Gap [ Time Frame: Up to 1 year ]
        Articular gap will be assessed on x-rays at clinical follow-ups up to 1 year after surgery at 2 weeks, 6 weeks, 3 months, and 1 year postoperatively.
      • Volar tilt [ Time Frame: Up to 1 year ]
        Volar tilt will be assessed on x-rays at clinical follow-ups up to 1 year after surgery at 2 weeks, 6 weeks, 3 months, and 1 year postoperatively.
      • Radial inclination [ Time Frame: Up to 1 year ]
        Radial inclination will be assessed on x-rays at clinical follow-ups up to 1 year after surgery at 2 weeks, 6 weeks, 3 months, and 1 year postoperatively.
      • Ulnar variance [ Time Frame: Up to 1 year ]
        Ulnar variance will be assessed on x-rays at clinical follow-ups up to 1 year after surgery at 2 weeks, 6 weeks, 3 months, and 1 year postoperatively.
      • Coronal Shift [ Time Frame: Up to 1 year ]
        Coronal shift will be assessed on x-rays at clinical follow-ups up to 1 year after surgery at 2 weeks, 6 weeks, 3 months, and 1 year postoperatively.
      • Grip Strength [ Time Frame: Up to 1 year ]
        Grip strength will be measured by the PI of the study with a Jamar grip dynamometer at clinical follow-ups up to 1 year after surgery at 2 weeks, 6 weeks, 3 months, and 1 year postoperatively.
      • Return to Work/Activities (quickDASH questionnaire) [ Time Frame: Up to 1 year ]
        The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. It will be administered at clinical follow-ups up to 1 year after surgery at 2 weeks, 6 weeks, 3 months, and 1 year postoperatively.
      • Pinch Strength [ Time Frame: Up to 1 year ]
        Pinch strength will be measured by the PI with a Pinch Dynamometer at clinical follow-ups up to 1 year after surgery at 2 weeks, 6 weeks, 3 months, and 1 year postoperatively.
      • Intraoperative Complications [ Time Frame: Time of Surgery ]

        Intraoperative complications will be assessed on 1 occasion, on the day of surgery. Intraoperative complications are defined as follows:

        • Loss of reduction
        • Conversion to alternate fixation
        • Hardware breakage
        • Fracture
        • Other


      Original Secondary Outcome: Same as current

      Information By: Hospital for Special Surgery, New York

      Dates:
      Date Received: February 25, 2015
      Date Started: February 2015
      Date Completion: January 2020
      Last Updated: January 19, 2017
      Last Verified: January 2017