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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

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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

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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:PURPOSE: Fixed-angle devices have been a major advancement in orthopedic fracture care and have become an attractive option for fixation of distal radius fractures. Several volar locking plates exist, but there is insufficient literature comparing the strengths of these plates. This study compares the biomechanical strength of two popular volar locking plate systems (Synthes LCP and Hand Innovations DVR-A) along with a nonlocking volar T-plate (Synthes). METHODS: Twenty-three formalin-fixed cadaveric forearms were divided into three groups with similar ages and bone densities. An unstable extra-articular fracture was created using a standardized osteotomy. Each group was fixed with one of the three plates. Each specimen was loaded in axial compression for 2000 cycles at a force of 400 N. Each specimen that completed cyclic testing was loaded to failure. Stiffness, yield point, and ultimate strength were recorded for each construct. RESULTS: Each fixed-angle construct completed all 2000 cycles. The nonlocking plates failed at an average of 560 cycles. The mean stiffness of the DVR-A, LCP, and the volar T-plates were 277.00, 343.17, and 175.67 N/mm, respectively. There was a statistically significant difference between both fixed-angle plates and the nonlocking plate (p < 0.05). The difference between each fixed-angle construct did not reach significance. Yield point and ultimate strength could only be determined for the two fixed-angle devices. There was no statistically significant difference between the constructs for both yield point (DVR-A = 855.56 N, LCP = 894.15 N) and ultimate strength (DVR-A = 1,021.97 N, LCP = 1,114.87 N). CONCLUSIONS: Given our data, fixed-angle constructs withstand cyclical loading representing normal physiologic forces encountered during post-operative rehabilitation. There was no significant biomechanical difference between the two fixed-angle constructs. Our results support that volar fixed-angle locking plates are an effective treatment for unstable extra-articular distal radius fractures, allowing early postoperative rehabilitation to safely be initiated.

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.

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