A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Evaluating the Effectiveness of Daily Vibration After Arthroscopic Rotator Cuff Repair

Lam, Patrick H.; Hansen, K.; Keighley, G.; Hackett, Maree L.; Murrell, George A. C.

doi:10.1177/0363546515599630

Cited by 11 publications

(6 citation statements)

References 43 publications

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“…We included 38 studies with 3072 patients for full-text review, as well as in the meta-analysis, as they met the final inclusion criteria. 1 , 4 , 40 , 41 , 42 , 43 , 44 , 46 , 5 , 50 , 52 , 53 , 54 , 56 , 57 , 6 , 8 , 10 , 11 , 12 , 13 , 14 , 15 , 20 , 21 , 22 , 23 , 25 , 28 , 29 , 31 , 32 , 33 , 34 , 36 , 37 , 38 , 39 , 4 , 40 , 41 , 42 , 43 , 44 , 46 , 50 , 52 , 53 , 54 , 56 , 57 The study characteristics of each included cohort are shown in Table I . A forest plot of retear rates is shown in Figure 2 .…”

Section: Resultsmentioning

confidence: 99%

The effect of age on risk of retear after rotator cuff repair: a systematic review and meta-analysis

Khazzam¹,

Sager²,

Box³

et al. 2020

JSES International

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Hypothesis The purpose of this study was to perform a systematic review and meta-analysis to determine the effect of age on rotator cuff repair failure. The hypothesis of this study was that increased patient age would lead to a higher rate of retears and/or repair failures after rotator cuff repair. Methods We conducted a systematic review and meta-analysis of level I and II studies evaluating patients undergoing rotator cuff repair that also included an imaging assessment of the structural integrity of the repair. Univariate and multivariate meta-regression was performed to assess the dependence of the retear rate on the mean age of the cohort, imaging modality, time to imaging, and publication year. Results The meta-regression included 38 studies with a total of 3072 patients. Significant heterogeneity in retear rates was found among the studies ( Q = 209.53, I 2 = 82.34, P < .001). By use of a random-effects model, the retear rate point estimate was 22.1% (95% confidence interval [CI], 18.6%-26.0%). On univariate analysis, type of imaging modality did not significantly influence the retear rate ( P = .188). On univariate analysis, mean age (odds ratio [OR], 1.05 [95% CI, 1.01-1.09]; P = .027) and mean time to imaging (OR, 1.04 [95% CI, 1.01-1.08]; P = .006) were associated with the retear rate. Publication year (OR, 0.94 [95% CI, 0.88-1.01]; P = .083) demonstrated a trend toward significance. On multivariate analysis, increased age was associated with a 5%/yr increased odds of retear (OR, 1.05 [95% CI, 1.01-1.08]; P = .025). The risk of retear doubled from 15% at age 50 years to >30% at age 70 years. Time to imaging demonstrated a trend toward increased odds of retear (OR, 1.03 [95% CI, 1.00-1.07]; P = .056). Publication year was not associated with the retear rate on multivariate analysis (OR, 0.96 [95% CI, 0.90-1.02]; P = .195). Conclusion The risk of retear after rotator cuff repair is associated with increased age and doubles between the ages of 50 and 70 years.

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Section: Resultsmentioning

confidence: 99%

The effect of age on risk of retear after rotator cuff repair: a systematic review and meta-analysis

Khazzam¹,

Sager²,

Box³

et al. 2020

JSES International

View full text Add to dashboard Cite

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“…This finding is in agreement with the small effect we previously reported, 12 but is in stark contrast to the majority of other chronic pain conditions. 40 – 46 Emerging clinical trial data have further substantiated our observation of limited placebo response in SCI patients. In a recent trial demonstrating the efficacy of botulinum toxin type A (BTXA), fewer than 10% of SCI patients administered saline achieved a meaningful reduction in pain (i.e., >30%).…”

Section: Discussionmentioning

confidence: 95%

Placebo response in neuropathic pain after spinal cord injury: a meta-analysis of individual participant data

Jutzeler¹,

Warner²,

Cragg³

et al. 2018

JPR

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BackgroundUnderstanding factors associated with high placebo responses in clinical trials increases the likelihood of detecting a meaningful treatment effect. The aim of the present study was to identify subject-level factors that contribute to placebo variability in patients with neuropathic pain due to spinal cord injury (SCI).MethodsMultiple regression analysis of patient data from randomized, double-blind, placebo-controlled trials (duration >4 weeks) involving individuals with SCI was performed. Patient demographics, as well as injury and pain characteristics were examined for their association with changes in pain rating from baseline to the end of the trial (i.e., placebo response). The overall effect of individual predictors was quantified with meta-analysis statistics.ResultsA total of 276 patients with SCI from six studies were included in the analysis. Based on the meta-analysis of subject-level predictors, larger placebo responses were associated with male subjects (β=0.635; standard error [SE]=0.262; p=0.016) and higher baseline pain (β=−0.146; SE=0.073; p=0.044). There were no significant effects for injury characteristics (i.e., severity, level, and time since injury) or pain characteristics (i.e., location and evoked). No significant publication bias was detected.ConclusionThe current meta-analysis of individual patient data demonstrated the importance of sex and baseline pain intensity on changes in pain ratings in the placebo arm of SCI central neuropathic pain randomized controlled clinical trials. Overall, our findings indicate that placebo responses occur independent of injury characteristics.

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“…It is hypothesized that because the PEUU scaffold has a long degeneration time, there are enough time for BMSCs to infiltrate and proliferate without interruption . Moreover, the mechanical stimulation is one of the key factors of tendon-to-bone regeneration in vivo . All these factors would contribute to the successful regeneration of rotator cuff.…”

Section: Discussionmentioning

confidence: 99%

Macroporous 3D Scaffold with Self-Fitting Capability for Effectively Repairing Massive Rotator Cuff Tear

Wang

Kang

Chen

et al. 2020

ACS Biomater. Sci. Eng.

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The postoperative retear rate of direct repair of massive rotator cuff tear has risen up to 40% because of the dissatisfied tendon-to-bone healing and poor regenerative potential of remnant rotator cuff tissue. A biological scaffold that connects the remnant rotator cuff tissue and bone might be a promising substitute. In the present study, we have developed a macroporous three-dimensional scaffold poly(ester-urethane)urea (PEUU), with self-fitting capability employing thermally induced phase separation (TIPS) technique. The scaffold provides oriented connected macropores for cells migration, and promoted tendon-to-bone healing on the basis of surgical repair. The scaffolds were characterized by scanning electron microscopy, stress–strain test and cell biocompatibility study. In vitro studies exhibited that PEUU scaffold with suitable elastic mechanical properties can better support proliferation and migration of rabbit bone mesenchymal stem cells (RBMSCs). After three months postreconstruction of massive rotator cuff tear in a rabbit model using PEUU scaffold, there was complete regeneration of rotator cuff with physical tendon-to-bone interface and continuous tendon tissue, as observed from histological analysis. Further, biomechanical testing demonstrated that rotator cuff induced by PEUU scaffold had no significant difference as compared to normal rotator cuff. This macroporous, mechanically matched scaffold is potentially suitable for the application in massive rotator cuff repair. In conclusion, this study demonstrates the high efficiency of the macroporous 3D scaffold with self-fitting capability in facilitating rotator cuff regeneration.

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A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Evaluating the Effectiveness of Daily Vibration After Arthroscopic Rotator Cuff Repair

Cited by 11 publications

References 43 publications

The effect of age on risk of retear after rotator cuff repair: a systematic review and meta-analysis

The effect of age on risk of retear after rotator cuff repair: a systematic review and meta-analysis

Placebo response in neuropathic pain after spinal cord injury: a meta-analysis of individual participant data

Macroporous 3D Scaffold with Self-Fitting Capability for Effectively Repairing Massive Rotator Cuff Tear

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