Trial Outcomes & Findings for Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures (NCT NCT00908895)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

120 participants

Primary outcome timeframe

6 months

Results posted on

2011-03-01

Participant Flow

Recruitment started in April of 2003 and finished in June of 2006.

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.

Participant milestones

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

Reasons for withdrawal

Reasons for withdrawal
Measure	Radio-radial Fixator Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)	Percutaneous Pinning Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
Overall Study Lost to Follow-up	1	3
Overall Study algodystrophy	2	2
Overall Study Adverse Event	1	1

Baseline Characteristics

Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radio-radial Fixator n=57 Participants Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)	Percutaneous Pinning n=63 Participants Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	51 Participants n=7 Participants	97 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Age Continuous	57 years STANDARD_DEVIATION 19 • n=5 Participants	54 years STANDARD_DEVIATION 16 • n=7 Participants	55.6 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	44 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment Canada	57 participants n=5 Participants	63 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

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

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

Outcome measures

Outcome measures
Measure	Radio-radial Fixator n=53 Participants Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)	Percutaneous Pinning n=57 Participants Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
The Grip Strength	98.3 Percentage of opposite side Interval 92.5 to 103.9	62.6 Percentage of opposite side Interval 56.1 to 68.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Radio-radial Fixator n=53 Participants Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)	Percutaneous Pinning n=57 Participants Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
Range of Movement of Wrist Dorsal flexion	93.8 Percentage of opposite side Interval 90.7 to 96.9	81.7 Percentage of opposite side Interval 77.8 to 85.6
Range of Movement of Wrist Volar flexion	93.5 Percentage of opposite side Interval 90.4 to 96.6	74.7 Percentage of opposite side Interval 69.5 to 79.9
Range of Movement of Wrist Pronation	98 Percentage of opposite side Interval 96.7 to 99.3	90 Percentage of opposite side Interval 87.2 to 92.8
Range of Movement of Wrist Supination	90 Percentage of opposite side Interval 86.5 to 93.5	80 Percentage of opposite side Interval 75.9 to 84.1
Range of Movement of Wrist Radial inclination	90.7 Percentage of opposite side Interval 86.1 to 95.3	71.1 Percentage of opposite side Interval 64.9 to 77.3
Range of Movement of Wrist Cubital inclination	94 Percentage of opposite side Interval 89.1 to 98.9	65.6 Percentage of opposite side Interval 57.7 to 73.5

Adverse Events

Radio-radial Fixator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Percutaneous Pinning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Stéphane Pelet, MD, PhD

Département d'orthopédie, CHA-Pavillon Enfant-Jésus Québec

Phone: 418-649-0252

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place