Can Complications of Titanium Elastic Nailing With End Cap for Clavicular Fractures Be Reduced?

Frigg, Arno; Rillmann, P.; Ryf, Christian; Glaab, Richard; Reissner, Lisa

doi:10.1007/s11999-011-1845-7

Cited by 18 publications

(5 citation statements)

References 24 publications

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“…These patient-and surgeon-specific variables may explain the wide variation in irritation rates reported by others (9%-64%) [1,4,6,20,22,23]. Some surgeons consider irritation as discomfort coexisting with the treatment rather than a complication.…”

Section: Discussionmentioning

confidence: 99%

“…Reported irritation rates range from 9% to 44% after plate fixation and 9% to 62% after IM nailing. It often is treated by surgical implant removal (a second operation) [1,4,6,[20][21][22][23]. However, comparative studies or studies regarding the development of implant-related irritation with followup beyond the first year or two are scarce [1,4,14,19,23].…”

Section: Introductionmentioning

confidence: 99%

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High Irritation and Removal Rates After Plate or Nail Fixation in Patients With Displaced Midshaft Clavicle Fractures

Hulsmans

Heijl

Houwert³

et al. 2017

Clinical Orthopaedics &Amp; Related Research

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Background Studies comparing plate with intramedullary nail fixation of displaced midshaft clavicle fractures show faster recovery in the plate group and implant-related complications in both groups after short-term followup (6 or 12 months). Knowledge of disability, complications, and removal rates beyond the first postoperative year will help surgeons in making a decision regarding optimal implant choice. However, comparative studies with followup beyond the first year or two are scarce. Questions/purposes We asked: (1) Does plate fixation or intramedullary nail fixation for displaced midshaft clavicle fractures result in less disability? (2) Which type of fixation, plate or intramedullary, is more frequently associated with implant-related irritation and implant removal? (3) Is plate or intramedullary fixation associated with postoperative complications beyond the first postoperative year?Methods Between January 2011 and August 2012, patients with displaced midshaft clavicle fractures were enrolled and randomized to plate or intramedullary nail fixation. A total of 58 patients with plate and 62 patients with intramedullary nails initially were enrolled. Minimum followup was 30 months (mean, 39 months; range, 30-51 months). Two patients (3%) with plate fixation and two patients (3%) with intramedullary nails were lost to followup. The QuickDASH was obtained at final followup and compared between patients who had plate fixation and those who had intramedullary nail fixation. Postoperative complications measured include infection, implant-related irritation, implant failure, nonunion, and refracture after implant removal. Indications for implant removal included implant-related irritation, implant failure, nonunion, patient's wish, or surgeon's preference. Results Between patients with plate versus intramedullary nail fixation, there were no differences in QuickDASH The institution of one or more of the authors (FJW, RMH, EJV) has received, during the study period, funding from the AO Foundation ((Dübendorf, Switzerland). All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research 1 editors and board members are on file with the publication and can be viewed on request. Each author certifies that his institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained. Conclusions After a mean followup of 39 months, disability scores were excellent. Major complications did not occur after the 1-year followup. A frequent and bothersome problem after both surgical treatments is implant-related irritation, resulting in high rates of implant removal, after 1 year. Future research could focus on analyzing risk factors for implant irritation or removal. Level of Evidence Level II, therapeutic study.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

High Irritation and Removal Rates After Plate or Nail Fixation in Patients With Displaced Midshaft Clavicle Fractures

Hulsmans

Heijl

Houwert³

et al. 2017

Clinical Orthopaedics &Amp; Related Research

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“…27 Studies have shown that the mean union time for clavicle fracture is from 2.2 months to 4 months. [28][29][30][31] Hence we feel that follow-up period of six months is sufficient to assess psychometric properties of outcome instrument in clavicle shaft fractures.…”

Section: Justification For Sample Size and Follow-up Durationmentioning

confidence: 99%

Validity and responsiveness of the Nottingham clavicle score in clavicle shaft fractures treated with titanium elastic nailing

Vishwanathan

Jain

Patel

2019

Journal of Clinical Orthopaedics and Trauma

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Background: The Nottingham Clavicle Score (NCS) has been recently described for functional outcome assessment after injuries to clavicle and the Acromioclavicular joint. However; validity and responsiveness are context specific psychometric terms and the NCS has not been previously described in surgically treated clavicle shaft fractures. Aim of the present study was to investigate validity and responsiveness of the NCS in clavicle fractures treated with titanium flexible nailing. Methods: This prospective study was undertaken on consecutively operated clavicle shaft fractures treated with titanium elastic nail from November 2013 to August 2016. Functional assessment using NCS was done at two and six months postoperatively. Construct validity was also evaluated by formulating the null hypothesis that there would be no difference in NCS at six months after open and closed reduction and in 15B1 and 15B2 fracture sub-types. The above two hypotheses were formulated based on previous studies that used Constant score and DASH score. Pre-specified hypothesis and results in accordance with the hypotheses suggest satisfactory construct validity. Responsiveness was evaluated using standardized response mean (SRM) and Effect size (ES). ES and SRM values !0.80 suggest satisfactory responsiveness. The proportion of patients having the least possible score of 0 points (floor effect) and the highest possible score of 100 points (ceiling effect) was evaluated at two and six months postoperatively. Floor and ceiling effect of <15% suggests satisfactory internal validity. Results: Thirty six consecutively operated patients were included in the study. The NCS at two months and six months was 69.6 AE 9.6 and 87.2 AE 7.1 respectively. The NCS at six months after fixation was 88.7 AE 4.8 in closed reduction cohort and 84.7 AE 9.4 in the open reduction cohort and this difference was not significant (p = 0.1). The NCS at six months after fixation was 85.3 AE 8.3 in 15B1 clavicular fractures and 89.7 AE 4.0 in 15B2 clavicular shaft fractures and this difference was also not significant (p = 0.07). All results pertaining to construct validity were in accordance with our hypothesis thereby suggesting that NCS demonstrates satisfactory construct validity. The ES and SRM were 1.8 and 2.6 respectively. NCS showed no ceiling (0%) or floor effect (0%) at two and six months postoperatively thereby suggesting adequate internal validity of the NCS. Conclusion: NCS has satisfactory construct validity, internal validity and responsiveness in surgically treated clavicle shaft fractures with titanium elastic nailing.

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“…The only difference between the two is that the Rockwood pin also has a trocar point on the machine thread end of the pin. Concerning the Titanium Elastic Nail (TEN) (Depuy Synthes, Warsaw, IN, USA or Stryker, Kalamazoo, MI, USA) the 43 studies that were incorporated in the analysis were comprised of seven level I, [25][26][27][28][29][30][31] eight level II, [32][33][34][35][36][37][38][39] eleven level III [40][41][42][43][44][45][46][47][48][49][50] and seventeen level IV [5,[51][52][53][54][55][56][57][58][59][60][61][62][63][64][65][66] studies. Another type of fixation described was the Sonoma CRx (Arthrex, Naples, FL, USA) for which 6 studies (three level I, [67][68][69] one level II, [70...…”

Section: Resultsmentioning

confidence: 99%

Functional outcomes and complications of intramedullary fixation devices for Midshaft clavicle fractures: a systematic review and meta-analysis

Hoogervorst

Dam²,

Hannink

2020

BMC Musculoskelet Disord

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Background: An alternative to the current gold standard in operative treatment of displaced midshaft clavicle fractures (DMCF) using plate osteosynthesis, is internal fixation by means of intramedullary fixation devices. These devices differ considerably in their specifications and characteristics and an evaluation of their clinical results is warranted. The aim of this systematic review is to generate an overview of functional outcomes and complications in the management of DMCF per available intramedullary device. Methods: A systematic review was conducted to identify all papers reporting functional outcomes, union rates and/or complications using an intramedullary fixation device for the management of midshaft clavicle fractures. Multiple databases and trial registries were searched from inception until February 2020. Meta-analysis was conducted based on functional outcomes and type of complication per type of intramedullary fixation device. Pooled estimates of functional outcomes scores and incidence of complications were calculated using a random effects model. Risk of bias and quality was assessed using the Cochrane risk of bias and ROBINS-I tools. The confidence in estimates were rated and described according to the recommendations of the GRADE working group. Results: Sixty-seven studies were included in this systematic review. The majority of studies report on the use of Titanium Elastic Nails (TEN). At 12 months follow up the Titanium Elastic Nail and Sonoma CRx report an average Constant-Murley score of 94.4 (95%CI 93-95) and 94.0 (95%CI 92-95) respectively (GRADE High). The most common reported complications after intramedullary fixation are implant-related and implant-specific. For the TEN, hardware irritation and protrusion, telescoping or migration, with a reported pooled incidence 20% (95%CI 14-26) and 12% (95%CI 8-18), are most common (GRADE Moderate). For the Rockwood/Hagie Pin, hardware irritation is identified as the most common complication with 22% (95%CI 13-35) (GRADE Low). The most common complication for the Sonoma CRx was cosmetic dissatisfaction in 6% (95%CI 2-17) of cases (GRADE Very low).

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Can Complications of Titanium Elastic Nailing With End Cap for Clavicular Fractures Be Reduced?

Cited by 18 publications

References 24 publications

High Irritation and Removal Rates After Plate or Nail Fixation in Patients With Displaced Midshaft Clavicle Fractures

High Irritation and Removal Rates After Plate or Nail Fixation in Patients With Displaced Midshaft Clavicle Fractures

Validity and responsiveness of the Nottingham clavicle score in clavicle shaft fractures treated with titanium elastic nailing

Functional outcomes and complications of intramedullary fixation devices for Midshaft clavicle fractures: a systematic review and meta-analysis

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