Fractures, ClosedNCT02390856
Volar Plate vs. Conventus DRS Fixation
A study testing Conventus DRS and Volar Plate in people with Fractures, Closed, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Fractures, Closed
- What is being tested?
- Conventus DRS and Volar Plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature patients (18-80)
- Unstable AO Type A and C1 fractures
- Closed injuries, acute (<14 days), displaced, and unstable
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Randomized Controlled Trial: Volar Plate vs. Conventus DRS Intramedullary Fixation for Distal Radius Fractures
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.
Read the 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.
- Conditions
- Fractures, Closed
- Being tested
- Conventus DRS, Volar Plate
- Medical subject headings
- Fractures, Closed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventus DRSDevice
Also called Conventus DRS Intramedullary Fixation Device
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.
Volar PlateDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Volar Plate | Active comparator | Patients in this group will undergo distal radius fracture fixation with a traditional volar plate. Receives: Device: Volar Plate |
| Conventus DRS | Experimental | Patients in this group will undergo distal radius fracture fixation with the Conventus DRS intramedullary fixation device. Receives: Device: Conventus DRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Secondary outcomes (15)
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)
Measured: 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
Measured: 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.
Measured: Up to 1 year
Tourniquet time
On one occasion, on the day of surgery, tourniquet time will be recorded in minutes.
Measured: Time of Surgery
Operative time
On one occasion, on the day of surgery, operative time will be recorded in minutes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Time of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Fractures, ClosedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Conventus Orthopaedics, Inc.
- Responsible party
- Sponsor
- Investigators
- Scott W Wolfe, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390856
- Sponsor's protocol ID
- 2014-211
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2015
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23515129Rozental 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.
PubMed 16516728Arora 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.
PubMed 17485996Limthongthang 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.
PubMed 24630941Gunther SB, Lynch TL. Rigid internal fixation of displaced distal radius fractures. Orthopedics. 2014 Jan;37(1):e34-8. doi: 10.3928/01477447-20131219-14.
PubMed 24683654Gradl 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.
PubMed 24268189van 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.
PubMed 23187156Palmer 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>.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Volar Plate vs. Conventus DRS Intramedullary Fixation for Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT02390856
- Acronym / sponsor ID
- 2014-211
- Conditions
- Fractures, Closed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Conventus Orthopaedics, Inc.
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volar Plate | Active comparator | Device: Volar PlatePatients in this group will undergo distal radius fracture fixation with a traditional volar plate. |
| Conventus DRS | Experimental | Device: Conventus DRSPatients in this group will undergo distal radius fracture fixation with the Conventus DRS intramedullary fixation device. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Skeletally mature patients (18-80)
- Unstable AO Type A and C1 fractures
- Closed injuries, acute (<14 days), displaced, and unstable
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventus DRSAlso: Conventus DRS Intramedullary Fixation DeviceThe 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. | Device | Conventus DRS |
| Volar PlateA 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. | Device | Volar Plate |
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) * None
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
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
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
15 secondary outcomes
Wrist Range of Motion
Time frame: Up to 1 year
Visual Analog Pain (VAS) Score
Time frame: Up to 1 year
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Time frame: Up to 1 year
Tourniquet time
Time frame: Time of Surgery
Operative time
Time frame: Time of Surgery
Articular Step off
Time frame: Up to 1 year
Articular Gap
Time frame: Up to 1 year
Volar tilt
Time frame: Up to 1 year
Radial inclination
Time frame: Up to 1 year
Ulnar variance
Time frame: Up to 1 year
Coronal Shift
Time frame: Up to 1 year
Grip Strength
Time frame: Up to 1 year
Return to Work/Activities (quickDASH questionnaire)
Time frame: Up to 1 year
Pinch Strength
Time frame: Up to 1 year
Intraoperative Complications
Time frame: Time of Surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Background: PubMed 23515129Tarallo 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.
- Background: PubMed 16516728Rozental 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.
- Background: PubMed 17485996Arora 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.
- Background: PubMed 24630941Limthongthang 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.
- Background: PubMed 24683654Gunther SB, Lynch TL. Rigid internal fixation of displaced distal radius fractures. Orthopedics. 2014 Jan;37(1):e34-8. doi: 10.3928/01477447-20131219-14.
- Background: PubMed 24268189Gradl 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.
- Background: PubMed 23187156van 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.
- BackgroundPalmer 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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Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures
Femoral Shaft Fractures, Femur Fractures
Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Intertrochanteric Femoral Fractures
Intertrochanteric Fractures, Intertrochanteric Fractures of the Hip
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott W Wolfe, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventus DRS and Volar Plate in people with Fractures, Closed, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Complications at 2 weeks (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02390856, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.