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Operative treatment of 2-part surgical neck fractures of the proximal humerus (AO 11-A3) in the elderly: Cement augmented locking plate Philos™ vs. proximal humerus nail MultiLoc®.

ABSTRACT: Proximal humeral fractures are with an incidence of 4-5 % the third most common fractures in the elderly. In 20 % of humeral fractures there is an indication for surgical treatment according to the modified Neer-Criteria. A secondary varus dislocation of the head fragment and cutting-out are the most common complications of angle stable locking plates in AO11-A3 fractures of the elderly. One possibility to increase the stability of the screw-bone-interface is the cement augmentation of the screw tips. A second is the use of a multiplanar angle stablentramedullary nail that might provide better biomechanical properties after fixation of 2-part-fractures. A comparison of these two treatment options augmented locking plate versus multiplanar angle stable locking nail in 2-part surgical neck fractures of the proximal humerus has not been carried out up to now.Forty patients (female/male, ?60 years or female postmenopausal) with a 2-part-fracture of the proximal humerus (AO type 11-A3) will be randomized to either to augmented plate fixation group (PhilosAugment) or to multiplanar intramedullary nail group (MultiLoc). Outcome parameters are Disabilities of the Shoulder, Arm and Hand-Score (DASH) Constant Score (CS), American Shoulder and Elbow Score (ASES), Oxford Shoulder Score (OSS), Range of motion (ROM) and Short Form 36 (SF-36) after 3 weeks, 6 weeks, 3 months, 6 months, 12 and 24 months.Because of the lack of clinical studies that compare cement augmented locking plates with multiplanar humeral nail systems after 2-part surgical neck fractures of the proximal humerus, the decision of surgical method currently depends only on surgeons preference. Because only a randomized clinical trial (RCT) can sufficiently answer the question if one treatment option provides advantages compared to the other method we are planning to perform a RCT.Clinical Trial ( NCT02609906 ), November 18, 2015, registered retrospectively.

SUBMITTER: Helfen T

PROVIDER: S-EPMC5084335 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Operative treatment of 2-part surgical neck fractures of the proximal humerus (AO 11-A3) in the elderly: Cement augmented locking plate Philos™ vs. proximal humerus nail MultiLoc®.

Helfen Tobias T Siebenbürger Georg G Mayer Marcel M Böcker Wolfgang W Ockert Ben B Haasters Florian F

BMC musculoskeletal disorders 20161028 1

<h4>Background</h4>Proximal humeral fractures are with an incidence of 4-5 % the third most common fractures in the elderly. In 20 % of humeral fractures there is an indication for surgical treatment according to the modified Neer-Criteria. A secondary varus dislocation of the head fragment and cutting-out are the most common complications of angle stable locking plates in AO11-A3 fractures of the elderly. One possibility to increase the stability of the screw-bone-interface is the cement augmen ...[more]

PMID: 27793135

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Project description:IntroductionCement augmentation of the proximal humerus internal locking system (PHILOS) screws might reduce complication rates in osteoporotic bones. This study compared the risk of mechanical failure during the first year after PHILOS™ treatment of proximal humerus fractures (PHF) without (control group) and with (augmented group) screw augmentation. Secondary objectives were to report shoulder functions, quality of life (QoL), adverse events (AEs), and reoperation rates.Materials and methodsThis multicenter randomized trial enrolled patients aged ≥ 65 years with displaced/unstable PHF from eight European centers. Randomization was performed during surgery through sealed opaque envelopes. Mechanical failures were assessed by two independent reviewers via radiographs, shoulder function by Quick DASH, SPADI, and Constant Murley scores, and QoL by EQ-5D. Follow-ups were planned at postoperative 6 weeks, 3, 6, and 12 months.ResultsThe preliminary analysis of 6-week radiographs of the first 59 enrolled patients suggested a mechanical failure rate lower than expected and the difference between groups was too small to be detected by the planned sample size of 144. The trial was prematurely terminated after 67 patients had been enrolled: 34 (27 eligible) in the control group and 33 (29 eligible) in the augmented group. Follow-ups were performed as planned. Nine patients had mechanical failures and the failure rates (95% CI) were: augmented group, 16.1% (5.5; 33.7); control group, 14.8% (4.2; 33.7); the relative risk (95% CI) for the augmented group was 1.09 (0.32; 3.65) compared to the control group (p = 1.000). No statistically significant differences in shoulder function, QoL, and AEs were observed between study groups at 1 year. Nine patients (15.8%) underwent a revision.ConclusionsDue to premature termination, the study was underpowered. A larger study will be necessary to determine if cement augmentation lowers the risk of mechanical failure rate.

Project description:BackgroundA lateral approach with open reduction and internal fixation with a plate is a very effective technique for the majority of distal fibular fractures. However, this open approach for ankle fixation may be complicated by wound dehiscence and infection, especially in high-risk patients. An alternative to plating is an intramedullary implant, which allows maintenance of length, alignment, and rotation and which allows for decreased soft tissue dissection. While there has been clinical data suggesting favorable short-term outcomes with these implants, there is no current biomechanical literature investigating this technology in this particular fracture pattern. This study sought to biomechanically compare an emerging technology with an established method of fixation for distal fibular fractures that traditionally require an extensive exposure.MethodsTen matched cadaveric pairs from the proximal tibia to the foot were prepared to simulate an Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association (AO/OTA) 44C2 ankle fracture and randomized to fixation with a distal fibular locking plate or intramedullary fibular rod. A constant 700-N axial load was applied, and all specimens underwent testing for external rotation stiffness, external rotation cyclic loading, and torque to failure. The syndesmotic diastasis, stiffness, torque to failure, angle at failure, and mode of failure were obtained from each specimen.ResultsThere was no significant difference in syndesmotic diastasis during cyclic loading or at maximal external rotation between the rod and plate groups. Post-cycle external rotation stiffness across the syndesmosis was significantly higher for the locking plate than the fibular rod. There was no significant difference between the rod and plate in torque at failure or external rotation angle. The majority of specimens had failure at the syndesmotic screw.ConclusionsIn the present cadaveric study of an AO/OTA 44C2 ankle fracture, a modern fibular rod demonstrated less external rotation stiffness while maintaining the syndesmotic diastasis to within acceptable tolerances and having similar failure characteristics.

Project description:BackgroundThe role of locking plate in lateral malleolar fracture fixation for the elderly remains unclear. The aim of our study is to compare radiological and functional outcomes in older patients (> 50 years) with AO/OTA 44B lateral malleolar fractures after locking plate (PLP) or one-third non-locking tubular plate (TP) lateral fixation.MethodsWe retrospectively reviewed the medical records of 72 patients (PLP group, 34 patients; TP group, 38 patients; mean age, 61.9 ± 7.6 years; range, 51-80 years; follow-up, 1 year). Patients with open fractures, syndesmosis injuries, and a previous ankle trauma or surgery were excluded. Demographic data, union rate, complications, radiographic outcomes, visual analog scale (VAS) scores, and foot and ankle outcome scores (FAOSs) between the groups were recorded and compared. We also investigated the association of clinical features with pain and function. Statistically, the Fisher's exact test was used for categorical variables and the Mann-Whitney U test for the continuous variables. The final model for the multiple regression analysis was used to predict factors related to functional outcomes.ResultsThere were no significant between-group differences in demographic data, complication rates, immediately postoperative distal fibula lengths, ankle osteoarthritis (OA) grades, talar tilt angles (TTAs) ≥ 2°, or reduction accuracy. All fractures achieved union. The PLP group had significantly lower rates of distal screw loosening, fibula shortening > 2 mm, OA grade progression, and TTAs ≥ 2°, and better FAOSs and VAS scores than was the case for the TP group after 1 year of follow-up (all p < 0.05). The severity of OA, TTA ≥ 2°, and distal screw loosening were positively associated with VAS scores, and negatively associated with FAOSs.ConclusionsWhen treating AO/OTA 44B fractures in patients over 50 years of age, PLPs provided better VAS scores, FAOSs, and radiological outcomes, including less fibula shortening > 2 mm, less osteoarthritic (OA) ankle progression, less implant removal rate, and fewer TTAs ≥ 2° than was the case for TPs after a 1-year follow-up.Level of evidenceTherapeutic level III.

Project description:BackgroundProximal humerus fractures (PHFs) are common fractures, especially in older female patients. These fractures are commonly treated surgically, but the consensus on the best treatment is still lacking.Methods and findingsThe primary aim of this multicenter, randomized 3-arm superiority, open-label trial was to assess the results of nonoperative treatment and operative treatment either with locking plate (LP) or hemiarthroplasty (HA) of 3- and 4-part PHF with the primary outcome of Disabilities of the Arm, Shoulder, and Hand (DASH) at 2-year follow-up. Between February 2011 and December 2019, 160 patients 60 years and older with 3- and 4-part PHFs were randomly assigned in 1:1:1 fashion in block size of 10 to undergo nonoperative treatment (control) or operative intervention with LP or HA. In total, 54 patients were assigned to the nonoperative group, 52 to the LP group, and 54 to the HA group. Five patients assigned to the LP group were reassigned to the HA group perioperatively due to high comminution, and all of these patients had 4-part fractures. In the intention-to-treat analysis, there were 42 patients in the nonoperative group, 44 in the LP group, and 37 in the HA group. The outcome assessors were blinded to the study group. The mean DASH score at 2-year follow-up was 30.4 (standard error (SE) 3.25), 31.4 (SE 3.11), and 26.6 (SE 3.23) points for the nonoperative, LP, and HA groups, respectively. At 2 years, the between-group differences were 1.07 points (95% CI [-9.5,11.7]; p = 0.97) between nonoperative and LP, 3.78 points (95% CI [-7.0,14.6]; p = 0.69) between nonoperative and HA, and 4.84 points (95% CI [-5.7,15.4]; p = 0.53) between LP and HA. No significant differences in primary or secondary outcomes were seen in stratified age groups (60 to 70 years and 71 years and over). At 2 years, we found 30 complications (3/52, 5.8% in nonoperative; 22/49, 45% in LP; and 5/49, 10% in HA group, p = 0.0004) and 16 severe pain-related adverse events. There was a revision rate of 22% in the LP group. The limitation of the trial was that the recruitment period was longer than expected due to a high number of exclusions after the assessment of eligibility and a larger exclusion rate than anticipated toward the end of the trial. Therefore, the trial was ended prematurely.ConclusionsIn this study, no benefit was observed between operative treatment with LP or HA and nonoperative treatment in displaced 3- and 4-part PHFs in patients aged 60 years and older. Further, we observed a high rate of complications related to operative treatments.Trial registrationClinicalTrials.gov NCT01246167.

Dataset Information

Operative treatment of 2-part surgical neck fractures of the proximal humerus (AO 11-A3) in the elderly: Cement augmented locking plate Philos™ vs. proximal humerus nail MultiLoc®.

Publications

Operative treatment of 2-part surgical neck fractures of the proximal humerus (AO 11-A3) in the elderly: Cement augmented locking plate Philos™ vs. proximal humerus nail MultiLoc®.

Similar Datasets

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