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