DRAFFT Trial – A review by James Gill
Percutaneous fixation with K- wires versus volar locking plate fixation in adults with a dorsally displaced fracture of the distal radius: RCT
BACKGROUND: Increasing use of expensive locking plates with lack of evidence
OBJECTIVE: to compare clinical effectiveness of K-wire with locking plates
METHODS: Multicentre (18), two arm parallel (K-wire vs. plate), assessor blinded (not surgeon or patient), randomised on a 1:1 (K-wire to plate) treatment basis. Stratified by centre, intra-articular fractures and age (50 yr. threshold, age used as a surrogate for bone density as all expected to be potential confounding factors.
|Age > 18 years
Dorsally displaced fracture of the distal radius within 3cm of the radiocarpal joint
Treating surgeon believed patient would benefit from surgical fixation
|Presented > 2 weeks post injury
Extension > 3cm from radio carpal joint
Open (Gustilo grading > 1)
If the articular surface could not be reduced by indirect techniques
Contra-indication to anaesthsia
Patient unable to complete questionnaires
1o PRWE = Patient rated wrist evaluation PROM
2o DASH, Eq5D & complications
STATS: Primary analysis on intention to treat basis. Secondary ‘per treatment’. Sub group age and intra-articular fractures
No evidence of a significant difference in PRWE scores at any time point. No difference in sub group analysis (age and intra-articular) or ‘per treatment basis.
There was evidence for a marginally significant (P=0.051) small treatment effect (-3.2) in favour of the plate group for the DASH score at 12 months only.
Complications equal for both groups
- Largest RCT
- Raised profile of distal radius fracture fixation
- Apart from omission of exclusions well written
- Selection bias:
12162 assessed for eligibility
7402 objective exclusions for age, open, unable to consent, unfit for surgery, > 2 weeks old
4121 subjective exclusions: Surgeons assessment of fracture configuration and decision whether the fracture required open reduction and internal fixation and > 3cm cm extension
178 eligible patients declined participation
- participants (230 K-wire & 231 plating)
This led to:
- Old female patients with fragility fractures over represented
- Low number of partial articular AO B1-3 fracture (table 1)
- Low proportion of high energy mechanism 0-2% RTC (table 1)
- Junior surgeons (59% SpR or staff grade) with low experience (13% performed < 10 platings, 26% < 20)
- Maybe it should not be viewed a criticism of the trial rather a snapshot of practice at the time
- Alternatively I wonder if the distal radius fracture in which plating versus K-wire fixation is deemed equivocal are more likely to be performed by junior surgeons whereas complex intra-articular fracture which clearly needs open reduction are more likely to be fixed by specialist upper limb consultants
- Not a mention of a single case of CRPS in 461 cases
- 75% of fractures treated with plating were placed in a cast post-operatively. Suggested that this would obviates one of the main advantages and key AO principle conferred by fixation in restoring early mobility
- Not long enough follow up to show advantages conferred by superior restoration of joint anatomy following open reduction and internal fixation
CHANGE IN PRACTICE: Yes – Reduction in use of locking plates even before results of trial released. Has it changed practice for the better? More questionable
CONCLUSION: I feel DRAFFT does not support its conclusion:
- Costa: In contrast to both the trend in surgical practice and the findings of previous studies, we found no difference in patient rated wrist evaluation in the 12 months after Kirschner wire fixation versus volar locking plate fixation. Kirschner wire fixation is cheaper and quicker to perform.
- Fullilove The correct conclusion to draw from the DRAFFT study is that for adults with a dorsally displaced fracture of the distal radius which needs surgical intervention, after excluding more than 85% of fractures which were not considered suitable for randomisation, and most of which will undergo plating, there are only marginal, if any, functional benefits of volar plating over wiring at one year.
- DRAFFT study examined a very selective group of adult dorsally-displaced fractures of the distal radius: these represented less than 10% of the cohort treated surgically in the United Kingdom.
- Goh BMJ published comments There is a definite group of adult patients with distal radius fracture out there who benefit as much from K wire fixation as volar plate fixation, with no major difference in outcome. As a result the unrestrained sprint toward management of most distal radius fracture with volar locking plate should be reassessed in term of cost-benefit profile.