Dataset Information

A protocol for a single-center, single-blinded randomized-controlled trial investigating volar plating versus conservative treatment of unstable distal radius fractures in patients older than 65?years.

ABSTRACT: BACKGROUND:Distal radius fractures (DRF) are very common in elderly patients, who present at the Emergency Department. Surgical treatment with open reduction and internal fixation using volar locking plates is widely prevalent despite the lack of evidence proving its superiority to conservative treatment with closed reduction and plaster immobilization. The purpose of this study is to investigate whether conservative treatment is superior to volar plating in terms of number of complications and results in a comparable or superior functional outcome in patients ?65?years. METHODS:In this single-center, single-blinded randomized-controlled trial, patients ?65?years with distal radius fractures will be invited to participate. A total of 50 patients per treatment arm is required to provide 80% statistical power at a 5% alpha level assuming a difference of 20% in complication rate between operatively and conservatively treated patients. Primary outcome measures will be complication rate, Quick DASH score (Quick Disabilities of the Arm, Shoulder and Hand), PRWE (Patient rated Wrist evaluation), and range of motion of the wrist. Secondary outcome measures will be grip strength, pinch gauge, pain, use of pain medication EQ5D score (European Quality of life - 5 dimensions), standardized radiographs. One year of follow-up is planned with data collection at the day of injury, after 2?weeks, after 5?weeks, after 6?months, and after 12?months. An intention-totreat and per-protocol analysis will be performed. DISCUSSION:This prospective trial helps to clarify the best treatment strategy for displaced DRF patients ?65?years. TRIAL REGISTRATION:This trial is approved by the Danish Scientific Ethical Committee (ID: 1-10-72-420-17) and registered at Clinicaltrials.gov (Trial registration number NCT03716661 ).

SUBMITTER: Pedersen J

PROVIDER: S-EPMC6599306 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A protocol for a single-center, single-blinded randomized-controlled trial investigating volar plating versus conservative treatment of unstable distal radius fractures in patients older than 65 years.

Pedersen Jonas J Mortensen Simon Oksbjerre SO Rölfing Jan Duedal JD Thorninger Rikke R

BMC musculoskeletal disorders 20190629 1

<h4>Background</h4>Distal radius fractures (DRF) are very common in elderly patients, who present at the Emergency Department. Surgical treatment with open reduction and internal fixation using volar locking plates is widely prevalent despite the lack of evidence proving its superiority to conservative treatment with closed reduction and plaster immobilization. The purpose of this study is to investigate whether conservative treatment is superior to volar plating in terms of number of complicati ...[more]

PMID: 31253145

Similar Datasets

Project description:BackgroundPrimary 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 methodsA 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 outcomecomplications assessed after 2 and 5 weeks and 6 and 12 months.Secondary outcomesQuick-DASH, PRWHE, range of motion, grip strength, EQ-5D-3L.Results148 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.ConclusionsComplication 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 evidenceII. Trial registration Clinicaltrials.gov NCT03716661, registered 23rd Oct 2018; Published protocol PMC6599306.

Project description:BackgroundThe most commonly used approach for distal radius fractures is the traditional Henry approach. However, it requires an intraoperative incision of the pronator quadratus (PQ) muscle, which results in a series of complications if the repair of the PQ fails.AimThe objective of this study was to investigate the efficacy of sparing the pronator quadratus for volar plating of the distal radius fractures.MethodsSeventy-six patients who suffered from distal radius fractures of types 23-B, 23-C1, and 23-C2 as per the AO Foundation and Orthopaedic Trauma Association (AO/OTA) classification were treated with volar locking plate fixation using either the PQ muscle incision and repair (group A, n = 39) or the PQ muscle preservation approach (group B, n = 37). Intraoperative index, postoperative efficacy and complications of patients were recorded and evaluated.ResultsAll patients were followed up for more than one year after surgery. All fractures achieved union. There were significant differences in mean operative time, mean intraoperative blood loss, and mean fracture healing time between the two groups. Still, there were no significant differences in limb function scores between the two groups at the 12-month postoperative follow-up. Outcomes assessed at 1 week, 1 month, and 3 months after surgery demonstrated significant differences in the mean range of motion and pain-related visual analog scale (VAS) between the two groups. As the range of motion and grip strength increased, the VAS scores decreased, and there was no significant difference between the two groups at 12 months postoperatively. Although tendon irritation and delayed carpal tunnel syndrome were more common in group A than in group B (7.6% vs. 0% and 5.1% vs. 0%, respectively), the differences were not statistically significant.ConclusionThe modified Henry approach with sparing pronator quadratus muscle has no significant advantage in the range of wrist motion and upper limb function in the late stage. Nevertheless, the intraoperative placement of the plate under the pronator quadratus muscle can shorten the operation time, reduce intraoperative bleeding, reduce early postoperative pain, promote early activity, and improve the patient's quality of life. It is recommended that the pronator be preserved at the time of surgery.

Project description:BACKGROUND:Distal radius fracture (DRF) is the most common upper extremity fracture that requires surgery. Operative treatment with a volar locking plate has proved to be the treatment of choice for unstable fractures. However, no consensus has been reached about the benefits of pronator quadratus (PQ) repair after volar plate fixation of DRF in terms of patient-reported outcome measures, pronation strength, and wrist mobility. METHODS:We searched the PubMed, Embase, Cochrane Central, and China National Knowledge Infrastructure (CNKI) databases up to March 13, 2020, and included randomized-controlled, non-randomized controlled, or case-control cohort studies that compared cases with and without PQ repair after volar plate fixation of DRF. We used a random-effects model to pool effect sizes, which were expressed as standardized mean differences (SMDs) and 95% confidence intervals. The primary outcomes included Disabilities of the Arm, Shoulder, and Hand scores and pronation strength. The secondary outcomes included the SMDs in pain scale score, wrist mobility, and grip strength. The outcomes measured were assessed for publication bias by using a funnel plot and the Egger regression test. RESULTS:Five randomized controlled studies and six retrospective case-control studies were included in the meta-analysis. We found no significant difference in primary and secondary outcomes at a minimum of 6-month follow-up. In a subgroup analysis, the pronation strength in the PQ repair group for AO type B DRFs (SMD = - 0.94; 95% CI, - 1.54 to - 0.34; p < 0.01) favored PQ repair, whereas that in the PQ repair group for non-AO type B DRFs (SMD = 0.39; 95% CI, 0.07-0.70; p = 0.02) favored no PQ repair. DISCUSSION:We found no functional benefit of PQ repair after volar plate fixation of DRF on the basis of the present evidence. However, PQ muscle repair showed different effects on pronation strength in different groups of DRFs. Future studies are needed to confirm the relationship between PQ repair and pronation strength among different patterns of DRF. REGISTRATION:This study was registered in the PROSPERO registry under registration ID No. CRD42020188343 . LEVEL OF EVIDENCE:Therapeutic III.

Project description:BackgroundThe surgical technique of radius distraction for stabilization of distal radioulnar joint (DRUJ) if intraoperative DRUJ instability was found after the fixation of distal radius fracture has been previously described, but this surgical technique lacks clinical and radiographic effect in minimal 3 years follow-up. We therefore evaluated the clinical outcome and radiographic results of radius distraction in minimal 3 years follow-up as long-term evaluation.MethodsWe reviewed the case series of distal radius fracture with concomitant DRUJ instability receiving radius distraction from the senior author over a 5-year period (January 1st, 2013, to June 30th, 2017) retrospectively. Radius distraction during volar plating was performed by moving the volar plate distally via compression screw loosening/fastening to achieve firm endpoint on the dorsopalmar stress test. The evaluations of radiographic, including bone union time and ulnar variance, and clinical outcomes, including grading of DRUJ instability, NRS of wrist pain, DASH score, MMWS score, and range of motion of operated wrist at final follow-up, were performed at clinic as minimum 3-year follow-up; a total 34 patients had been evaluated.ResultsAt minimal post-operative 36 months follow-up, all cases demonstrated acceptable wrist range of motion with stable DRUJs, low NRS of wrist pain (0.6, SD 0.7), and satisfactory DASH score (mean 9.1, SD 6.2) and MMWS score (mean 87, SD 10). There were no cases suffering from nonunion of distal radius. The mean ulnar variance of injured wrist and uninjured wrist were -1.2 mm and 0.2 mm, respectively (SD 1.0 and 0.6) with significant statistical difference.ConclusionsRadius distraction during volar fixation of distal radius fracture should be considered if DRUJ instability was found by the dorsopalmar stress test intraoperatively, and the long-term DRUJ stability could be achieved by maintenance of normal-to-negative ulnar variance, with decreased wrist pain and satisfactory function outcome.Level of evidenceTherapeutic Level IV.

Dataset Information

A protocol for a single-center, single-blinded randomized-controlled trial investigating volar plating versus conservative treatment of unstable distal radius fractures in patients older than 65?years.

Publications

A protocol for a single-center, single-blinded randomized-controlled trial investigating volar plating versus conservative treatment of unstable distal radius fractures in patients older than 65 years.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets