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1.
Expert Rev Med Devices ; 18(10): 995-1022, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34503387

ABSTRACT

INTRODUCTION: Pedicle screws are commonly used for spinal procedures for fusion stability, which is particularly important in osteoporotic patients, who are at an increased risk of requiring revision procedures. AREAS COVERED: A systematic review and meta-analysis were conducted to compare clinical effectiveness of conventional pedicle screws (CPS) vs fenestrated pedicle screws (FPS) in patients undergoing spinal surgery. Primary outcomes included screw loosening, revision surgeries (involving an implant) and reoperations (not involving intervention on an implant) in patients treated with CPS vs FPS, sub-stratified by with and without osteoporosis. Secondary outcomes included changes in pain scores. Forty-eight studies with 8,302 patients were included, with 1,565 (19.18%) treated with FPS and 6,710 (80.82%) treated with CPS. FPS was associated with a lower risk of screw loosening (p = 0.001) vs CPS. In the general population, there was a non-significant trend of lower revision rate, but no difference in reoperation rate, between patients treated with FPS vs CPS. In osteoporotic patients, revision rates were significantly lower for FPS vs CPS (p = 0.009). EXPERT OPINION: This review suggests that FPS are effective for surgical fixation and reduce rates of screw loosening, and in osteoporotic patients, revision surgeries, compared to CPS.


Subject(s)
Osteoporosis , Pedicle Screws , Spinal Fusion , Bone Cements , Humans , Lumbar Vertebrae , Osteoporosis/surgery , Spinal Fusion/adverse effects , Treatment Outcome
2.
J Med Econ ; 24(1): 394-401, 2021.
Article in English | MEDLINE | ID: mdl-33617369

ABSTRACT

AIMS: Clinical and economic outcomes associated with an early discharge protocol for cementless total hip arthroplasty (THA) via a direct anterior approach (DAA) on a standard table without a dedicated traction table) were assessed. These outcomes were compared against a benchmark of THA care approximated from a national database. MATERIALS AND METHODS: This retrospective, observational, comparative cohort study evaluated 250 patients receiving THA with a standard table DAA approach under an early discharge protocol at a medical center in Japan between 2016 and 2017 (intervention). Patients were propensity score-matched to a standard care control group comprised of THA patients within the Japan Medical Data Center database. A generalized linear model (GLM) using gamma distribution with log-link compared hospital length of stay (LOS) and total cost. Post-operative function and pain (Japanese Orthopaedic Association hip score [JOA] and Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire [JHEQ]) were assessed for DAA patients. RESULTS: After propensity score matching, 239 patients were included in each cohort. The patients in the intervention and control group were comparable in regard to age, gender, comorbidities, and procedure year. Adjusted hospital LOS for DAA as part of an early discharge protocol was significantly shorter than for control patients (4.76 vs. 25.36 days). Adjusted total costs were significantly lower (29%) for the intervention group (¥1,613,800 vs. ¥2,254,757; US$14,390 vs. US$20,105). The 3-month follow-up complication rate was 0.42% (superficial infection) for intervention vs. 3.35%. The intervention group had no readmissions and post-operative function and pain scores significantly improved (JHEQ pain score 7.2 ± 5.0 to 24.2 ± 4.6, JOA 48.4 ± 12.8 to 94.3 ± 7.0; p-value < .001). LIMITATIONS: The study is not randomized and EMR and administrative claims data may lack information (i.e. some clinical variables) required for inference. Also, the data may not represent the whole Japanese population. CONCLUSIONS: An early discharge protocol demonstrated compatibility with standard table DAA in a Japanese hospital, providing cost savings, while maintaining reliable clinical outcomes.


Subject(s)
Arthroplasty, Replacement, Hip , Cohort Studies , Hospitals , Humans , Japan , Length of Stay , Observational Studies as Topic , Patient Discharge , Postoperative Complications , Retrospective Studies
3.
Curr Med Res Opin ; 36(11): 1839-1845, 2020 11.
Article in English | MEDLINE | ID: mdl-32910700

ABSTRACT

OBJECTIVE: Patients that undergo total hip replacement (THA) are at risk of revision surgery. This study evaluated the cumulative incidence of revision following a medial collared, triple tapered (MCTT) primary hip stem versus other implants in real-world settings using electronic medical records. METHODS: This was a retrospective cohort study that used the Mercy Healthcare Systems - Orthopedics Database (MHSOD) to identify ACTIS total hip system, a MCTT primary hip stem for THA, and any other primary THA between 2016 and 2020. A Kaplan-Meier analysis was conducted to evaluate the risk of revision over time between the MCTT hip stem and other implants. In order to control for the confounding, a multivariable Cox model was developed to evaluate the risk of revision between the two groups. RESULTS: There were 1213 patients treated with MCTT hip stem and 6916 patients treated with other implants. The Kaplan-Meier analysis showed statistically significant difference (p value = .006) in cumulative incidences for all-cause revisions between the MCTT hip stem and other implants. The cumulative incidence at 3 years was 1.08% (0.43-2.72%) for the MCTT hip stem, while it was 2.63% (2.19-3.16%) for other implants. After adjusting for patient demographics, clinical characteristics, prescribed medications, and surgeon characteristics, the multivariable Cox proportional hazard model showed the MCTT hip stem was statistically significantly associated with 57% lower risk of revisions compared with other implants (HR, 0.43; 95% CI, 0.19-0.97; p-value = .042). CONCLUSIONS: This real-world study found that the incidence of revision after treatment with MCTT primary hip stem was significantly lower than for other implants.


Subject(s)
Arthroplasty, Replacement, Hip/methods , Hip Prosthesis , Reoperation/mortality , Aged , Aged, 80 and over , Arthroplasty, Replacement, Hip/adverse effects , Arthroplasty, Replacement, Hip/instrumentation , Databases, Factual/statistics & numerical data , Female , Hip Prosthesis/adverse effects , Humans , Incidence , Kaplan-Meier Estimate , Male , Middle Aged , Prosthesis Design , Reoperation/statistics & numerical data , Retrospective Studies , Treatment Outcome
4.
J Comp Eff Res ; 8(5): 317-326, 2019 04.
Article in English | MEDLINE | ID: mdl-30681001

ABSTRACT

AIM: To assess the clinical and economic impact of flowable gelatin hemostatic matrix (FGHM) in anterior cervical spine surgery (ACSS). PATIENTS & METHODS: A total of 451 patients with performed ACSS were included to compare FGHM with conventional hemostatic methods for clinical and cost outcomes using propensity score matching method. RESULTS: The comparisons of the matched 125 pairs observed that FGHM was associated with significantly lower blood transfusion volume (11.2 vs 36.3 ml; p = 0.039), shorter postsurgery hospital stay length (3.7 vs 4.7 days; p = 0.002), shorter operation time (103.5 vs 117.7 min; p = 0.004), lower drainage placement rate (51.2 vs 89.6%; p < 0.001) and also lower total hospital costs (median ¥64,717 vs ¥65,064; p = 0.035). CONCLUSION: Use of FGHM in ACSS improved perioperative outcomes without increasing hospital costs.


Subject(s)
Cervical Vertebrae/surgery , Diskectomy/methods , Gelatin/therapeutic use , Hemostatics/therapeutic use , Spinal Fusion/methods , Adult , Aged , Blood Transfusion/statistics & numerical data , Female , Gelatin/economics , Hospital Costs , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Models, Economic , Operative Time , Propensity Score , Retrospective Studies
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