Dataset Information

Clinical outcome of implant removal after fracture healing. Design of a prospective multicentre clinical cohort study.

ABSTRACT:

Background

The clinical results of removal of metal implants after fracture healing are unknown and the question whether to remove or to leave them in is part of discussion worldwide. We present the design of a prospective clinical multicentre cohort study to determine the main indications for and expectations of implant removal, the influence on complaints, the incidence of surgery related complications and the socio-economic consequences of implant removal.

Methods/design

In a prospective multicentre clinical cohort study at least 200 patients with a healed fracture after osteosynthesis with a metal implant are included for analyzing the outcome after removal. Six hospitals in the Netherlands are participating. Special questionnaires are designed. The follow up after surgery will be at least six months. The primary endpoint is the incidence of surgery related complications. Secondary endpoints are the influence of removal on preoperative symptoms and complaints and the socio-economic consequences.

Discussion

By performing this study we hope to find profound arguments to remove or not to remove metal implants after fracture healing that can help to develop clear guidelines for daily practice.

Trial registration

NTR1297, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1297.

SUBMITTER: Vos DI

PROVIDER: S-EPMC3493388 | biostudies-literature | 2012 Aug

REPOSITORIES: biostudies-literature

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Publications

Clinical outcome of implant removal after fracture healing. Design of a prospective multicentre clinical cohort study.

Vos Dagmar I DI Verhofstad Michael H J MH Hanson Beate B van der Graaf Yolanda Y van der Werken Chris C

BMC musculoskeletal disorders 20120815

<h4>Background</h4>The clinical results of removal of metal implants after fracture healing are unknown and the question whether to remove or to leave them in is part of discussion worldwide. We present the design of a prospective clinical multicentre cohort study to determine the main indications for and expectations of implant removal, the influence on complaints, the incidence of surgery related complications and the socio-economic consequences of implant removal.<h4>Methods/design</h4>In a p ...[more]

PMID: 22894749

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Project description:IntroductionGeriatric Fracture Centers (GFCs) are dedicated treatment units where care is tailored towards elderly patients who have suffered fragility fractures. The primary objective of this economic analysis was to determine the cost-utility of GFCs compared with usual care centres.MethodsThe primary analysis was a cost-utility analysis that measured the cost per incremental quality-adjusted life-year gained from treatment of hip fracture in GFCs compared with treatment in usual care centres from the societal perspective over a 1-year time horizon. The secondary analysis was a cost-utility analysis from a societal perspective over a lifetime time horizon. We evaluated these outcomes using a cost-utility analysis using data from a large multicentre prospective cohort study comparing GFCs versus usual care centres that took place in Austria, Spain, the USA, the Netherlands, Thailand and Singapore.ResultsGFCs may be cost-effective in the long term, while providing a more comprehensive care plan. Patients in usual care centre group were slightly older and had fewer comorbidities. For the 1-year analysis, the costs per patient were slightly lower in the GFC group (-$646.42), while the quality-adjusted life-years were higher in the usual care centre group (+0.034). The incremental cost-effectiveness ratio was $18 863.34 (US$/quality-adjusted life-year). The lifetime horizon analysis found that the costs per patient were lower in the GFC group (-$7210.35), while the quality-adjusted life-years were higher in the usual care centre group (+0.02). The incremental cost-effectiveness ratio was $320 678.77 (US$/quality-adjusted life-year).ConclusionsThis analysis found that GFCs were associated with lower costs compared with usual care centres. The cost-savings were greater when the lifetime time horizon was considered. This comprehensive cost-effectiveness analysis, using data from an international prospective cohort study, found that GFC may be cost-effective in the long term, while providing a more comprehensive care plan. A greater number of major adverse events were reported at GFC, nevertheless a lower mortality rate associated with these adverse events at GFC. Due to the minor utility benefits, which may be a result of greater adverse event detection within the GFC group and much greater costs of usual care centres, the GFC may be cost-effective due to the large cost-savings it demonstrated over the lifetime time horizon, while potentially identifying and treating adverse events more effectively. These findings suggest that the GFC may be a cost-effective option over the lifetime of a geriatric patient with hip fracture, although future research is needed to further validate these findings.Level of evidenceEconomic, level 2.Trial registration numberNCT02297581.

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Project description:BackgroundThis study was to evaluate the effects of repetitive brief ischemia (RBI) on bone healing in patients with tibial shaft fractures.MethodsIn this prospective clinical trial, patients with tibia shaft fractures were enrolled between January 2016 and January 2021. The intermittent pneumatic compression (IPC) device was used to make RBI on the affected limb after surgical operation 24 h. The inflation pressure was the systolic pressure of patients + 50 mmHg. Patients were received 30 s inflation/30 s deflation 30 times twice a day for 4 weeks. The primary outcome was bone healing time and the secondary outcomes were the rates of delayed union and nonunion, the rates of venous thrombosis of lower limbs, Johner-Wruhs scores, Lysholm knee score, VAS scores, postoperative complications, serum BMP-2, osteocalcin (OC) and bone specific alkaline phosphatase (BS-ALP).ResultsA total of 32 patients were enrolled finally and all were completed with a 12 months follow-up. All the fractures were healed and the bone healing time was 3(1) months in RBI group. However, the bone healing time of control group was 4(1) and there was statistical difference between the two groups (p < 0.01). No patient with fracture delayed union, nonunion and venous thrombosis of lower limbs in RBI group. 2 patients were delayed union in the control group. In RBI group, the Lysholm knee score was 83(6) at 6 months and 100(8) at 12 months. In the control group, the score was 78(4) and 90.5(17), there was statistical difference between the two groups (p < 0.01, p = 0.014, respectively). VAS scores were postoperative 2 weeks 6(1) in RBI group and 7(0.5) in the control group, there was statistical difference between the two groups (p = 0.016). There were 2 patients with intramuscular venous thrombosis of lower extremity in control group. Besides, RBI treatment increased the serum BMP-2, OC and BS-ALP at postoperative 2 weeks and 1 month.ConclusionsRBI is a new method to accelerate bone healing in tibia shaft fracture patients and is a simple and noninvasive method.Trial registrationChinese clinical trial registry, ChiCTR-INR-17014208 . Registered 28 December 2017-Retrospectively registered.

Dataset Information

Clinical outcome of implant removal after fracture healing. Design of a prospective multicentre clinical cohort study.

Background

Methods/design

Discussion

Trial registration

Publications

Clinical outcome of implant removal after fracture healing. Design of a prospective multicentre clinical cohort study.

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