Date post: | 31-May-2015 |
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A PROSPECTIVE RANDOMIZED TRIAL COMPARING NONOPERATIVE TREATMENT WITH VOLAR LOCKING PLATE FIXATION FOR DISPLACED AND UNSTABLE DISTAL RADIAL FRACTURES IN PATIENTS SIXTY-FIVE YEARS OF AGE AND OLDER
Investigation performed at the Department of Trauma Surgery and Sports Medicine, Medical University Innsbruck, Innsbruck, Austria
Published by: THE JOURNAL OF BONE & JOINT SURGERY , December 7,2011.
Background
Increased tendency for ORIF of displaced and unstable fracture ,despite the lack of adequate prospective randomized trials examining whether open reduction and internal fixation (ORIF) with a volar locking plate is superior to non-operative (cast) treatment.
Study design
Prospective randomized trial with one year fellow up. Therapeutic level I evidence.
Selection criteria
Patients over 65 year old with initial inadequate reduction and patients with subsequent loss of reduction at the one-week follow-up examination.
dorsal radial tilt >10°and/or radial shortening > 3 mm and/or intra- articular step-off > 2 mm
Study power
The sample size calculated to provide 80% power to detect a difference of 10 points in the PRWE score, which they consider to be clinically relevant is 68 patients .
Number of patients included was 73 patients . 36 patients treated operatively ORIF with a
volar locking plate and 37 patients treated by closed reduction and cast immobilization .
Randomization
The patients were randomized to either ORIF or non-operative treatment with use of sequentially numbered, sealed envelopes.
Outcome Evaluation
Patient-Rated Wrist Evaluation (PRWE) score
Disabilities of the Arm, Shoulder and Hand (DASH) score
The pain level The range of wrist motion The rate of complications Radiographic measurements including
dorsal radial tilt, radial inclination, and ulnar variance.
Results
There were no significant differences in range of motion or the level of pain during the entire follow-up period (p > 0.05).
Patients in the operative treatment group had lower DASH and PRWE scores,
indicating better wrist function, in the early postoperative time period (p < 0.05), but there were no significant differences between the groups at six and twelve months.
Grip strength was significantly better at all times in the operative treatment
group (p < 0.05). Dorsal radial tilt, radial inclination, and radial shortening were significantly better
in the operative treatment group than in the nonoperative treatment group at the time of the latest follow-up (p < 0.05).
The number of complications was significantly higher in the operative treatment
group (thirteen compared with five, p < 0.05). posttraumatic osteoarthritis in patients with intra-articular fractures was
significantly higher in the nonoperative treatment group than in the operative treatment group (p < 0.05)
Conclusions
At the 12 month follow up examination, the range of motion, the level of pain, and the PRWE and DASH scores were not different between the operative and non-operative treatment groups.
Patients in the operative treatment group had
better grip strength through the entire time period.
Achieving anatomical reconstruction did not convey any improvement in terms of the range of motion or the ability to perform daily living activities in the study.
The outcome is at 1 year fellow up , may be too early for arthritis pain and we do not know how bad are these pains , and their impaction on DASH and PRWE
What is the study power for DASH score ??? is it still 80% with the same number of patients ???! Because the study mensioned only PRWE score
Is it dobble blind or only the patients is blined.
From this table
TABLE III Radiographic Outcomes
The WORST fracture X-ray in this study after one year was
Normal Operative Non-operative
Palmer tilt degree 12 -4.2 -22,7
Radial inclination degree
23 18,6 6,9
Ulna variance mm 0.9 2.5 6,1
Step-off mm 0 0.7 1,7
The worst case is as this fracture
Dorsal tilt of 22° , a radial shortening of 7 mm and radial inclination 6° , ulna variance 4 mm
But not this one ….
May be there should be an other acceptable range for people over 65,but not the usual one for younger patients !!
Sylvester Stallon, 66 year