Eclipse stemless shoulder prosthesis vs. Univers II shoulder prosthesis: a multicenter, prospective randomized controlled trial.

BACKGROUND: Total shoulder arthroplasty is an accepted treatment for glenohumeral osteoarthritis. The Arthrex Eclipse shoulder prosthesis is a stemless, canal-sparing humeral prosthesis with bone ingrowth capacity on the trunnion, as well as through the fenestrated hollow screw, that provides both diaphyseal and metaphyseal load sharing and fixation. METHODS: Between 2013 and 2018, 16 sites in the United States enrolled 327 patients (Eclipse in 237 and Arthrex Univers II in 90). All patients had glenohumeral arthritis refractory to nonsurgical care. Strict exclusion criteria were applied to avoid confounding factors such as severe patient comorbidities, arthritis not consistent with osteoarthritis, and medical or prior surgical treatments that may have affected outcomes. Patients were randomized to the Eclipse or Univers II group via block randomization. RESULTS: In total, 149 Eclipse and 76 Univers II patients reached 2-year follow-up (139 Eclipse patients [93.3%] and 68 Univers II patients [89.5%] had complete data). The success rate using the Composite Clinical Success score was 95% in the Eclipse group vs. 89.7% in the Univers II group. No patient exhibited radiographic evidence of substantial humeral radiolucency, humeral migration, or subsidence at any point. Reoperations were performed in 7 patients (3.2%) in the Eclipse group and 3 (3.8%) in the Univers II group. CONCLUSION: The Arthrex Eclipse shoulder prosthesis is a safe and effective humeral implant for patients with glenohumeral arthritis at 2-year follow-up, with no differences in outcomes compared with the Univers II shoulder prosthesis.

A descriptive analysis of child-relevant systematic reviews in the Cochrane Database of Systematic Reviews.

BACKGROUND: Systematic reviews (SRs) are considered an important tool for decision-making. There has been no recent comprehensive identification or description of child-relevant SRs. A description of existing child-relevant SRs would help to identify the extent of available child-relevant evidence available in SRs and gaps in the evidence base where SRs are required. The objective of this study was to describe child-relevant SRs from the Cochrane Database of Systematic Reviews (CDSR, Issue 2, 2009). METHODS: SRs were assessed for relevance using pre-defined criteria. Data were extracted and entered into an electronic form. Univariate analyses were performed to describe the SRs overall and by topic area. RESULTS: The search yielded 1666 SRs; 793 met the inclusion criteria. 38% of SRs were last assessed as up-to-date prior to 2007. Corresponding authors were most often from the UK (41%). Most SRs (59%) examined pharmacological interventions. 53% had at least one external source of funding. SRs included a median of 7 studies (IQR 3, 15) and 679 participants (IQR 179, 2833). Of all studies, 48% included only children, and 27% only adults. 94% of studies were published in peer-reviewed journals. Primary outcomes were specified in 72% of SRs. Allocation concealment and the Jadad scale were used in 97% and 25% of SRs, respectively. Adults and children were analyzed separately in 12% of SRs and as a subgroup analysis in 14%. Publication bias was assessed in only 14% of SRs. A meta-analysis was conducted in 68% of SRs with a median of 5 trials (IQR 3, 9) each. Variations in these characteristics were observed across topic areas. CONCLUSIONS: We described the methodological characteristics and rigour of child-relevant reviews in the CDSR. Many SRs are not up-to-date according to Cochrane criteria. Our study describes variation in conduct and reporting across SRs and reveals clinicians' ability to access child-specific data.

Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials.

OBJECTIVE: The aim of this study was to conduct a systematic review of the efficacy of music therapy (MT) on pain and anxiety in children undergoing clinical procedures. METHODS: We searched 16 electronic databases of published and unpublished studies, subject bibliographies, reference lists of relevant articles, and trials registries. Two reviewers independently screened 4559 citations and reviewed the full manuscript of 393 studies. Nineteen studies met the inclusion criteria: randomized controlled trial, children aged 1 month to 18 years were examined, music was used as an intervention, and the study measured pain or anxiety. Music therapy was considered active if a music therapist was involved and music was used as a medium for interactive communication. Passive music therapy was defined as listening to music without the involvement of a music therapist. RESULTS: The 19 included trials involved 1513 subjects. The methodological quality of the studies was generally poor. Overall, MT showed a significant reduction in pain and anxiety (standardized mean difference [SMD] -0.35; 95% confidence interval [CI], -0.55 to -0.14; 9 studies; N = 704; I(2) = 42%). When analyzed by outcome, MT significantly reduced anxiety (SMD -0.39; 95% CI, -0.76 to -0.03; 5 studies; n = 284; I(2) = 52.4%) and pain (SMD -0.39; 95% CI, -0.66 to -0.11; 5 studies; N = 465; I(2) = 49.7%). There was no evidence of publication bias. CONCLUSIONS: Music is effective in reducing anxiety and pain in children undergoing medical and dental procedures. Music can be considered an adjunctive therapy in clinical situations that produce pain or anxiety.

Revision total knee arthroplasty with cemented components and uncemented intramedullary stems.

Sixty-three failed total knee arthroplasties in 60 patients (27 females, 33 males; average age, 66 years) were treated consecutively with revision using cemented component fixation and an uncemented stem. Patients were followed for a mean of 5.75 years (range, 2-10 years); none were lost to follow-up. There were 12 (19%) re-revisions: 6 (10%) were revised for aseptic loosening, 4 (6%) for recurrent infection, and 2 (3%) for instability. Knee Society Pain Scores improved from 56 to 81, and function scores improved from 49 to 62 points. Latest radiographs in retained knees showed none with definite femoral loosening but 4 with tibial component loosening. Combining those revised for aseptic loosening and radiographic aseptic loosening, mechanical failure occurred in 10 patients (16%).