Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

• Sponsor: Hopital de l'Enfant-Jesus (Other)
• Overall Status: Completed
• CT.gov ID: NCT00908895
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

The treatment of extra-articular distal radius fractures is still controversial. In Canada, most patients with unstable fractures are treated with pinning and cast. Results are often associated with shortening and lack of function.

The purpose of the study is to compare stabilization with a radio-radial fixator to the usual method, suggesting that the radio-radial fixator will provide more strength at 6 months follow-up.

Condition or Disease	Intervention/Treatment	Phase
Radius Fractures	Procedure: Radio-radial fixator; Procedure: Percutaneous pinning	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Non-bridging Radio-radial Fixator Compared to Percutaneous Pinning for Unstable Distal Radius Fracture. A Prospective Randomized Trial.
• Study Start Date: Apr 1, 2003
• Actual Primary Completion Date: May 1, 2007
• Actual Study Completion Date: May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radio-radial fixator Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)	Procedure: Radio-radial fixator; Using the Distal Radius Fixator from Synthes. A single splint for 5 days.
Active Comparator: Percutaneous pinning Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks	Procedure: Percutaneous pinning; Insert two K-wires in the distal radius, one in the fracture line dorsally and one from the styloid. A cast for 6 weeks.

Outcome Measures

Primary Outcome Measures

1. The Grip Strength [6 months]

   Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.

Secondary Outcome Measures

1. Range of Movement of Wrist [6 months]

   Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination. Motion is described as a percentage of the opposite side.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Distal radius fracture Frykman I or II

• Unstable fracture according to Lafontaine's criteria

• Fracture line more than 1cm form the joint line

• Closed fracture

• Age > 18 years

• Surgery performed between 72 hours from the trauma

• Monotrauma

• Patient signed the informed consent

Exclusion Criteria:

• Distal radius fracture Frykman III-VI (intra-articular fracture)

• Open fracture

• Polytraumatism

• Stable or non-displaced fracture

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Département d'orthopédie, CHA-Pavillon Enfant-Jésus	Québec	Quebec	Canada	G1J1Z4

Sponsors and Collaborators

• Hopital de l'Enfant-Jesus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00908895
• Other Study ID Numbers: PEJ-206
• First Posted: May 27, 2009
• Last Update Posted: Mar 1, 2011
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: Radius fractures; Radio-radial fixator; Percutaneous pinning; Grip strength
• Additional relevant MeSH terms: Fractures, Bone; Radius Fractures

Study Results

Participant Flow

Recruitment Details	Recruitment started in April of 2003 and finished in June of 2006.
Pre-assignment Detail	Only surgical fractures were addressed to the research team, after prior selection by orthopedic surgeon. So we didn't see all radius fractures in the department.

Arm/Group Title	Radio-radial Fixator	Percutaneous Pinning
Arm/Group Description	Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)	Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
Period Title: Overall Study
STARTED	57	63
COMPLETED	53	57
NOT COMPLETED	4	6

Baseline Characteristics

Arm/Group Title	Radio-radial Fixator	Percutaneous Pinning	Total
Arm/Group Description	Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)	Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks	Total of all reporting groups
Overall Participants	57	63	120
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	46 80.7%	51 81%	97 80.8%
>=65 years	11 19.3%	12 19%	23 19.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (19)	54 (16)	55.6 (18)
Sex: Female, Male (Count of Participants)
Female	40 70.2%	44 69.8%	84 70%
Male	17 29.8%	19 30.2%	36 30%
Region of Enrollment (participants) [Number]
Canada	57 100%	63 100%	120 100%

Outcome Measures

1. Primary Outcome

Title	The Grip Strength
Description	Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

No participant changed to the other group. Patients lost or with complications were not analyzed

Arm/Group Title	Radio-radial Fixator	Percutaneous Pinning
Arm/Group Description	Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)	Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
Measure Participants	53	57
Mean (95% Confidence Interval) [Percentage of opposite side]	98.3	62.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Radio-radial Fixator, Percutaneous Pinning
	Comments	We assess that 15% is a significative strength difference. According to a 80% study power, a SD at 25% and a 20% lost to follow-up, we found 118 patients for the all study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	70
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 25
	Estimation Comments

2. Secondary Outcome

Title	Range of Movement of Wrist
Description	Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination. Motion is described as a percentage of the opposite side.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radio-radial Fixator	Percutaneous Pinning
Arm/Group Description	Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)	Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
Measure Participants	53	57
Dorsal flexion	93.8	81.7
Volar flexion	93.5	74.7
Pronation	98	90
Supination	90	80
Radial inclination	90.7	71.1
Cubital inclination	94	65.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Radio-radial Fixator, Percutaneous Pinning
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	90
	Confidence Interval	() 95%; 80 to 100
	Parameter Dispersion	Type: Standard Deviation; Value: 10
	Estimation Comments

Adverse Events

Arm/Group Title	Radio-radial Fixator		Percutaneous Pinning
Arm/Group Description	Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)		Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
All Cause Mortality
	Radio-radial Fixator		Percutaneous Pinning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Radio-radial Fixator		Percutaneous Pinning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/63 (0%)
Other (Not Including Serious) Adverse Events
	Radio-radial Fixator		Percutaneous Pinning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/63 (0%)

Limitations/Caveats

Very long time between the end of the study and the manuscript preparation due to temporarily lack of statistician and the need for some national associations that the study is not published before presentation.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.