A Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures

Closed Frykman Type II Fracture of Right Radial Head Clinical Trial

Official title:

A Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410070
• Other study ID #: 1011126
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: April 1, 2015
• Start date: January 2011
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: The Second Hospital of Qinhuangdao
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

From January 2011 to September 2012, 157 patients with distal radial fractures were allocated into group A (n=83) and B (n=74). Patients in group A were treated through a 1.5 to 2-cm long incision, and patients in group B were treated through the conventional flexor carpi radialis approach. All fractures were fixed with volar plates. Patients were assessed range of motion of the wrist, grip strength of the hand, and pronation strength of the wrist. Results were analyzed with the Statistical Package for Social Sciences 13.0. A P < 0.05 was statistically significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Fernandez type II-IV radial fractures.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Closed Frykman Type II Fracture of Right Radial Head
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• Incision
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Qinhuangdao

References & Publications (2)

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. Review. — View Citation

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	range of motion of the wrist	measurement of range of motion of the wrist with a goniometer, at 2 years follow-up.	2 years	Yes
Secondary	grip strength of the hand	Assessment of grip strength of the hand using a Baseline hydraulic hand dynamometer, at 2 years follow-up.	2 years	Yes
Secondary	pronation strength of the forearm	Isometric testing of pronation torque, McConkey method at 5 positions of rotation (90° of supination, 45° of supination, neutral, 45° of pronation, and 80° of pronation) , at 2 years follow-up.	2 years	Yes