NCT02410070

Brief Summary

The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

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

January 1, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
Last Updated

April 7, 2015

Status Verified

March 1, 2015

Enrollment Period

3.9 years

First QC Date

March 18, 2015

Last Update Submit

April 1, 2015

Conditions

Closed Frykman Type II Fracture of Right Radial Head

Keywords

Distal radial fracturepronator quadratusmini-approachvolar platingopen reduction and internal fixation

Outcome Measures

Primary Outcomes (1)

  • range of motion of the wrist

    measurement of range of motion of the wrist with a goniometer, at 2 years follow-up.

    2 years

Secondary Outcomes (2)

  • grip strength of the hand

    2 years

  • pronation strength of the forearm

    2 years

Study Arms (2)

Though Volar Minimal Incision

EXPERIMENTAL

Patients in group A were treated through a small Incision.

Procedure: Incision

Though Convectional Incision

ACTIVE COMPARATOR

Patients in group B were treated through the conventional Incision

Procedure: Incision

Interventions

IncisionPROCEDURE

The objective of this report is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.

Though Convectional IncisionThough Volar Minimal Incision

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fernandez type II-IV radial fractures.

You may not qualify if:

  • Fernandez type I radial fracture.
  • Fernandez type V radial fracture.
  • Open radial fractures.
  • Surgery using K-wires or screws alone.
  • The use of external fixators.
  • multiple fractures, pathological fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Skouras E, Hosseini Y, Berger V, Wegmann K, Koslowsky TC. Operative treatment and outcome of unstable distal radial fractures using a palmar T-miniplate at a non-specialized institution. Strategies Trauma Limb Reconstr. 2013 Nov;8(3):155-60. doi: 10.1007/s11751-013-0170-y. Epub 2013 Aug 6.

    PMID: 23918414RESULT

  • Protopsaltis TS, Ruch DS. Volar approach to distal radius fractures. J Hand Surg Am. 2008 Jul-Aug;33(6):958-65. doi: 10.1016/j.jhsa.2008.04.018.

    PMID: 18656773RESULT

Study Officials

  • Xu Zhang, MD

    The Second Hospital of Qinhunangdao

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 18, 2015

First Posted

April 7, 2015

Study Start

January 1, 2011

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

April 7, 2015

Record last verified: 2015-03