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VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years.


ABSTRACT:

Background

Primary aim: to compare complications of operative vs non-operative treatment of unstable distal radius fractures (DRF) fulfilling national clinical guidelines for operative treatment. Secondary aim: to compare the functional outcomes.

Materials and methods

A single-centre randomized controlled trial of unstable DRF. 50 patients: volar locking plate, 2 weeks casting + 3 weeks orthosis. 50 patients: 5 weeks casting.

Primary outcome

complications assessed after 2 and 5 weeks and 6 and 12 months.

Secondary outcomes

Quick-DASH, PRWHE, range of motion, grip strength, EQ-5D-3L.

Results

148 patients were screened from November 2019 to March 2021. 48 patients did not want to participate or were unable to participate in the follow-up. 100 patients were randomized and 85 patients were available for full analysis due to there being 4 deaths, 6 withdrawals, 1 wrong inclusion, 1 emigration, 1 refracture, 1 patient with compartment syndrome, and 1 who was advised to undergo surgery after being randomized to non-operative treatment. Median age was 74 years (range 65-92), 81 women/19 men, 42 right/58 left side, 87 retired, 11 smokers, 86 ASA class 1 or 2. Complication rates did not statistical significantly vary between the operative and non-operative group: 20.9% (9/43) vs 16.6% (7/42), p = 0.78 (Fisher's exact test). Complications were driven by sensory disturbances. Four reoperations were performed: two in the non-operative group: carpal tunnel syndrome; two in the operative group: one carpal tunnel syndrome, one protruding screw causing extensor tendon irritation. Mean difference in Quick-DASH varied from 2.3 (95% CI - 3 to 8) pre-injury to 4.2 (- 4 to 12) at 12 months. Quick-DASH and PRWHE were neither statistically nor clinically-relevant different between groups.

Conclusions

Complication rates after operative and non-operative treatment of DRF were similar. Volar plating did not improve the functional outcome after 5 weeks, 6 months, and 12 months. These findings are in line with recent RCTs and mandate a revision of guidelines towards more conservative treatment.

Take home messages

(1) consider non-operative treatment in elderly patients sustaining unstable DRFs; (2) choosing operative treatment in patients older than 65 years should not be the gold standard; (3) however, non-operative treatment still carries a risk for complications.

Level of evidence

II. Trial registration Clinicaltrials.gov NCT03716661, registered 23rd Oct 2018; Published protocol PMC6599306.

SUBMITTER: Thorninger R 

PROVIDER: S-EPMC9705678 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years.

Thorninger Rikke R   Wæver Daniel D   Tjørnild Michael M   Lind Martin M   Rölfing Jan Duedal JD  

Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology 20221128 1


<h4>Background</h4>Primary aim: to compare complications of operative vs non-operative treatment of unstable distal radius fractures (DRF) fulfilling national clinical guidelines for operative treatment. Secondary aim: to compare the functional outcomes.<h4>Materials and methods</h4>A single-centre randomized controlled trial of unstable DRF. 50 patients: volar locking plate, 2 weeks casting + 3 weeks orthosis. 50 patients: 5 weeks casting.<h4>Primary outcome</h4>complications assessed after 2 a  ...[more]

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