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Volar Plate vs. Conventus DRS Fixation

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ClinicalTrials.gov Identifier: NCT02390856
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
Conventus Orthopaedics, Inc.
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
Fractures, Closed Device: Conventus DRS Device: Volar Plate Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial: Volar Plate vs. Conventus DRS Intramedullary Fixation for Distal Radius Fractures
Actual Study Start Date : February 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Volar Plate
Patients in this group will undergo distal radius fracture fixation with a traditional volar plate.
Device: Volar Plate
A volar plate is a metallic plate fastened directly to the fractured bone with screws, to hold the fracture fragments in proper position. Volar plate fixation is the traditional surgical method for distal radius fractures.

Experimental: Conventus DRS
Patients in this group will undergo distal radius fracture fixation with the Conventus DRS intramedullary fixation device.
Device: Conventus DRS
The Conventus DRS (TM) is an intramedullary device intended to treat distal radius fractures. The device remains flexible during placement, but is made rigid at the completion of the surgical implant procedure. The implant is made from titanium alloy (Ti-6A1-4V) and Nitinol.
Other Name: Conventus DRS Intramedullary Fixation Device




Primary Outcome Measures :
  1. 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)
    • None

  2. 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
    • Hardware breakage
    • Hardware removal
    • Return to OR
    • Tendinopathy
    • Tendon rupture
    • Neuropathy
    • Superficial infection
    • Deep infection
    • Wound dehiscence
    • Incisional pain
    • Chronic Regional Pain Syndrome (CRPS)
    • None

  3. Change from Baseline in Complications at 3 months [ Time Frame: 3 months ]

    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)
    • None

  4. Change from Baseline in Complications at 1 year [ Time Frame: 1 year ]

    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)
    • None


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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.

  4. Tourniquet time [ Time Frame: Time of Surgery ]
    On one occasion, on the day of surgery, tourniquet time will be recorded in minutes.

  5. Operative time [ Time Frame: Time of Surgery ]
    On one occasion, on the day of surgery, operative time will be recorded in minutes.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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
    • None



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390856


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Conventus Orthopaedics, Inc.
Investigators
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Principal Investigator: Scott W Wolfe, MD Hospital for Special Surgery, New York

Publications:
Palmer AK, Hale JE. Conventus DRS Plating System: A Preliminary Report [White paper]. Conventus Orthopedics 2013. Retrieved from <http://www.conventusortho.com/wp-content/uploads/2015/03/4473-1-Rev-2-White-Paper-Conventus-Distal-Radius-System-A-Preliminary-Report.pdf>.

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02390856     History of Changes
Other Study ID Numbers: 2014-211
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Fractures, Closed
Fractures, Bone
Wounds and Injuries