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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 SIXTYFIVE 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
Prospectiverandomizedtrialwithoneyearfellowup.
Therapeuticlevel I evidence.
Selectioncriteria
 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 sizecalculated 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 includedwas 73 patients .
36 patients treatedoperatively ORIF with a

volarlockingplate and 37 patients treated by
closedreduction and cast immobilization .
Randomization
The patients were randomized to either ORIF
or non-operative treatment with use of
sequentially numbered, sealed envelopes.
OutcomeEvaluation
 Patient-RatedWristEvaluation (PRWE) score
 Disabilitiesof the Arm, Shoulder and Hand





(DASH) score
The painlevel
The range of wristmotion
The rate of complications
Radiographicmeasurementsincludingdorsal
radial tilt, radial inclination, and ulnarvariance.
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 nonoperative treatment groups.
 Patients in the operative treatment group had better grip

strength through the entire time period.
 Achieving anatomical reconstruction did not convey

anyimprovement 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 studymensionedonly PRWE
score
 Is it dobble blind oronly the patients is blined.
From thistable

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

23

18,6

6,9

Ulnavariance mm 0.9

2.5

6,1

Step-off mm

0.7

1,7

Radial
inclinationdegree

0
The worst case is as
thisfracture

Dorsal tilt of 22° , a radial shortening of 7 mm
and radial inclination 6° , ulna variance 4 mm
But not thisone….
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

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Colles fracture

  • 1. A PROSPECTIVE RANDOMIZED TRIAL COMPARING NONOPERATIVE TREATMENT WITH VOLAR LOCKING PLATE FIXATION FOR DISPLACED AND UNSTABLE DISTAL RADIAL FRACTURES IN PATIENTS SIXTYFIVE YEARS OF AGE AND OLDER
  • 2.  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.
  • 3. 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.
  • 5. Selectioncriteria  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
  • 6. Study power  The sample sizecalculated 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 includedwas 73 patients . 36 patients treatedoperatively ORIF with a volarlockingplate and 37 patients treated by closedreduction and cast immobilization .
  • 7. Randomization The patients were randomized to either ORIF or non-operative treatment with use of sequentially numbered, sealed envelopes.
  • 8. OutcomeEvaluation  Patient-RatedWristEvaluation (PRWE) score  Disabilitiesof the Arm, Shoulder and Hand     (DASH) score The painlevel The range of wristmotion The rate of complications Radiographicmeasurementsincludingdorsal radial tilt, radial inclination, and ulnarvariance.
  • 9. 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)
  • 10. 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 nonoperative treatment groups.  Patients in the operative treatment group had better grip strength through the entire time period.  Achieving anatomical reconstruction did not convey anyimprovement in terms of the range of motion or the ability to perform daily living activities in the study.
  • 11.
  • 12.  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
  • 13.  What is the study power for DASH score ??? is it still 80% with the same number of patients ???!Because the studymensionedonly PRWE score  Is it dobble blind oronly the patients is blined.
  • 14. From thistable TABLE III Radiographic Outcomes
  • 15. The WORST fracture X-ray in this study after one year was Normal Operative Non-operative Palmer tilt degree 12 -4.2 -22,7 23 18,6 6,9 Ulnavariance mm 0.9 2.5 6,1 Step-off mm 0.7 1,7 Radial inclinationdegree 0
  • 16. The worst case is as thisfracture Dorsal tilt of 22° , a radial shortening of 7 mm and radial inclination 6° , ulna variance 4 mm
  • 18. May be there should be an other acceptable range for people over 65,but not the usual one for younger patients !!