Volar Plate vs. Conventus DRS Fixation
Primary Purpose
Fractures, Closed
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conventus DRS
Volar Plate
Sponsored by
About this trial
This is an interventional treatment trial for Fractures, Closed
Eligibility 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
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Volar Plate
Conventus DRS
Arm Description
Patients in this group will undergo distal radius fracture fixation with a traditional volar plate.
Patients in this group will undergo distal radius fracture fixation with the Conventus DRS intramedullary fixation device.
Outcomes
Primary Outcome Measures
Change from Baseline in Complications at 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
Change from Baseline in Complications at 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
Change from Baseline in Complications at 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
Change from Baseline in Complications at 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
Wrist Range of Motion
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
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
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
On one occasion, on the day of surgery, tourniquet time will be recorded in minutes.
Operative time
On one occasion, on the day of surgery, operative time will be recorded in minutes.
Articular Step off
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
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
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
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
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
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
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)
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
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
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
Full Information
NCT ID
NCT02390856
First Posted
February 25, 2015
Last Updated
February 6, 2019
Sponsor
Hospital for Special Surgery, New York
Collaborators
Conventus Orthopaedics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02390856
Brief Title
Volar Plate vs. Conventus DRS Fixation
Official Title
Randomized Controlled Trial: Volar Plate vs. Conventus DRS Intramedullary Fixation for Distal Radius Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
Conventus Orthopaedics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 Description
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 retrospective review of 303 patients who had undergone volar plate fixation and found that implant-related complications had occurred in 5% of the patients (2). Of these, common complications seen were tendon rupture, screw loosening, and penetration into the articular space. While Tarallo et al studied only hardware related complications, other studies have reported complications associated of volar locking plate fixation as high as 22-27% (3,4). The flexor pollicis longus in particular is vulnerable to rupture, as hardware prominence at the watershed line of the distal radius exposes the FPL and other flexor tendons to frictional forces which result in fraying and rupture (5). Prominent pegs or screws dorsally threaten the extensor pollicis longus and neighboring extensor tendons.
Intramedullary fixation has limited data to date, and the current methods are applicable to a relatively narrow subset of radial fracture types. In a case series of three patients, Gunther and Lynch have shown that intramedullary fixation performed with a partially flexible rod that can be locked into rigid position once implanted in the bone resulted in good functional outcomes (6). Patients returned to their daily lives and at one-year post-operatively no adverse effects were reported. A prospective study analyzing the comparative functional outcomes between intramedullary nail versus volar plate fixation similarly found that functional recovery was comparative between the two groups, and that complication rates were slightly lower in the intramedullary fixation cohort (7). The authors of this study however noted the continued potential for screw penetration into the distal radioulnar joint (DRUJ).
The Conventus DRS expandable intramedullary fixation device used in this proposed study is FDA approved. A cadaveric study compared the fixation strength of the Conventus DRS with fixed angle volar plate fixation and demonstrated equivalency between the two for axial compression mean stiffness and dorsal bend mean stiffness (8). The Conventus DRS has been used in Europe where over 250 patients have been treated with the device. A safety and efficacy 'white paper' of the first 60 patients treated for a wide variety of fractures demonstrated excellent improvements in DASH scores with few hardware related events and an overall adverse event profile of 8.3%. (9) There was one re-operation for loss of fixation and four minor cases of neuritis that resolved. The device is FDA-approved in the US, and is being used across the country.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Closed
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Volar Plate
Arm Type
Active Comparator
Arm Description
Patients in this group will undergo distal radius fracture fixation with a traditional volar plate.
Arm Title
Conventus DRS
Arm Type
Experimental
Arm Description
Patients in this group will undergo distal radius fracture fixation with the Conventus DRS intramedullary fixation device.
Intervention Type
Device
Intervention Name(s)
Conventus DRS
Other Intervention Name(s)
Conventus DRS Intramedullary Fixation Device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Volar Plate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Complications at 2 weeks
Description
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
Time Frame
2 weeks
Title
Change from Baseline in Complications at 6 weeks
Description
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
Time Frame
6 weeks
Title
Change from Baseline in Complications at 3 months
Description
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
Time Frame
3 months
Title
Change from Baseline in Complications at 1 year
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Wrist Range of Motion
Description
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)
Time Frame
Up to 1 year
Title
Visual Analog Pain (VAS) Score
Description
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
Time Frame
Up to 1 year
Title
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Description
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.
Time Frame
Up to 1 year
Title
Tourniquet time
Description
On one occasion, on the day of surgery, tourniquet time will be recorded in minutes.
Time Frame
Time of Surgery
Title
Operative time
Description
On one occasion, on the day of surgery, operative time will be recorded in minutes.
Time Frame
Time of Surgery
Title
Articular Step off
Description
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.
Time Frame
Up to 1 year
Title
Articular Gap
Description
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.
Time Frame
Up to 1 year
Title
Volar tilt
Description
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.
Time Frame
Up to 1 year
Title
Radial inclination
Description
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.
Time Frame
Up to 1 year
Title
Ulnar variance
Description
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.
Time Frame
Up to 1 year
Title
Coronal Shift
Description
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.
Time Frame
Up to 1 year
Title
Grip Strength
Description
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.
Time Frame
Up to 1 year
Title
Return to Work/Activities (quickDASH questionnaire)
Description
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.
Time Frame
Up to 1 year
Title
Pinch Strength
Description
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.
Time Frame
Up to 1 year
Title
Intraoperative Complications
Description
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
Time Frame
Time of Surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott W Wolfe, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23515129
Citation
Tarallo L, Mugnai R, Zambianchi F, Adani R, Catani F. Volar plate fixation for the treatment of distal radius fractures: analysis of adverse events. J Orthop Trauma. 2013 Dec;27(12):740-5. doi: 10.1097/BOT.0b013e3182913fc5.
Results Reference
background
PubMed Identifier
16516728
Citation
Rozental TD, Blazar PE. Functional outcome and complications after volar plating for dorsally displaced, unstable fractures of the distal radius. J Hand Surg Am. 2006 Mar;31(3):359-65. doi: 10.1016/j.jhsa.2005.10.010.
Results Reference
background
PubMed Identifier
17485996
Citation
Arora R, Lutz M, Hennerbichler A, Krappinger D, Espen D, Gabl M. Complications following internal fixation of unstable distal radius fracture with a palmar locking-plate. J Orthop Trauma. 2007 May;21(5):316-22. doi: 10.1097/BOT.0b013e318059b993.
Results Reference
background
PubMed Identifier
24630941
Citation
Limthongthang R, Bachoura A, Jacoby SM, Osterman AL. Distal radius volar locking plate design and associated vulnerability of the flexor pollicis longus. J Hand Surg Am. 2014 May;39(5):852-60. doi: 10.1016/j.jhsa.2014.01.038. Epub 2014 Mar 14.
Results Reference
background
PubMed Identifier
24683654
Citation
Gunther SB, Lynch TL. Rigid internal fixation of displaced distal radius fractures. Orthopedics. 2014 Jan;37(1):e34-8. doi: 10.3928/01477447-20131219-14.
Results Reference
background
PubMed Identifier
24268189
Citation
Gradl G, Mielsch N, Wendt M, Falk S, Mittlmeier T, Gierer P, Gradl G. Intramedullary nail versus volar plate fixation of extra-articular distal radius fractures. Two year results of a prospective randomized trial. Injury. 2014 Jan;45 Suppl 1:S3-8. doi: 10.1016/j.injury.2013.10.045. Epub 2013 Nov 4.
Results Reference
background
PubMed Identifier
23187156
Citation
van Kampen RJ, Thoreson AR, Knutson NJ, Hale JE, Moran SL. Comparison of a new intramedullary scaffold to volar plating for treatment of distal radius fractures. J Orthop Trauma. 2013 Sep;27(9):535-41. doi: 10.1097/BOT.0b013e3182793df7.
Results Reference
background
Citation
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>.
Results Reference
background
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Volar Plate vs. Conventus DRS Fixation
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