An interventional study of Conventus DRS and Volar Plate in Fractures, Closed, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-02-08.
Sponsored by Hospital for Special Surgery, New York · Not applicable, Interventional, and Treatment
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.
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.
44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.
This study's enrollment of 12 is below the median of 45 across 34 interventional studies indexed under Fractures, Closed.
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Exclusion Criteria:
Patients in this group will undergo distal radius fracture fixation with a traditional volar plate.
Device: Volar Plate
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.
Also known as: Conventus DRS Intramedullary Fixation Device
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.
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
Time frame: 2 weeks
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
Time frame: 6 weeks
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
Time frame: 3 months
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
Time frame: 1 year
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)
Time frame: Up to 1 year
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
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
Tourniquet time
On one occasion, on the day of surgery, tourniquet time will be recorded in minutes.
Time frame: Time of Surgery
Operative time
On one occasion, on the day of surgery, operative time will be recorded in minutes.
Time frame: Time of Surgery
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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
Time frame: Time of Surgery
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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