NCT02390856

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

3.8 years

First QC Date

February 25, 2015

Last Update Submit

February 6, 2019

Conditions

Fractures, Closed

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    1 year

Secondary Outcomes (15)

  • Wrist Range of Motion

    Up to 1 year

  • Visual Analog Pain (VAS) Score

    Up to 1 year

  • Patient-Rated Wrist Evaluation (PRWE) questionnaire

    Up to 1 year

  • Tourniquet time

    Time of Surgery

  • Operative time

    Time of Surgery

  • +10 more secondary outcomes

Study Arms (2)

Volar Plate

ACTIVE COMPARATOR

Patients in this group will undergo distal radius fracture fixation with a traditional volar plate.

Device: Volar Plate

Conventus DRS

EXPERIMENTAL

Patients in this group will undergo distal radius fracture fixation with the Conventus DRS intramedullary fixation device.

Device: Conventus DRS

Interventions

Conventus DRSDEVICE

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
Conventus DRS
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.

Volar Plate

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (8)

  • 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.

    PMID: 23515129BACKGROUND

  • 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.

    PMID: 16516728BACKGROUND

  • 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.

    PMID: 17485996BACKGROUND

  • 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.

    PMID: 24630941BACKGROUND

  • 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.

    PMID: 24683654BACKGROUND

  • 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.

    PMID: 24268189BACKGROUND

  • 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.

    PMID: 23187156BACKGROUND

  • 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>.

    BACKGROUND

MeSH Terms

Conditions

Fractures, Closed

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Scott W Wolfe, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 18, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

US(1)