IlluminOss photodynamic bone stabilization system improves pain and function in the treatment of humeral metastatic disease.

IF 4.9 1区 医学 Q1 ORTHOPEDICS
Richard M Terek, Richard McGough, Nicola Fabbri, Felix Cheung, Brian Brigman, James Wittig, Cynthia Emory, Albert Aboulafia, Raffi Avedian, Joel Mayerson, Robert Henshaw, Nickolas Reimer, William Eward, Kurt Weiss, John Healey, David Mohler, Brock Adams
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引用次数: 0

Abstract

Aims: The aim of the LightFix Trial was to evaluate the clinical outcomes for one year after the treatment of impending and completed pathological fractures of the humerus using the IlluminOss System (IS), and to analyze the performance of this device.

Methods: A total of 81 patients with an impending or completed pathological fracture were enrolled in a multicentre, open label single cohort study and treated with IS. Inclusion criteria were visual analogue scale (VAS) Pain Scores > 60 mm/100 mm and Mirels' Score ≥ 8. VAS pain, Musculoskeletal Tumor Society (MSTS) Upper Limb Function, and The European Organization for Research and Treatment of Cancer QoL Group Bone Metastases Module (QLQ-BM22) scores were all normalized to 100, and radiographs were obtained at baseline and at 14, 30, 90, 180, and 360 days postoperatively.

Results: The mean VAS pain score decreased significantly from 84 (SD 15) to 50 (SD 29), 38 (SD 30), 31 (SD 29), 31 (SD 29), and 21 (SD 23) between the baseline and follow-up times (p < 0.001). The mean MSTS function scores significantly increased from 27 (SD 19) to 52 (SD 22), 60 (23), 67 (SD 23), 72 (SD 26), and 83 (SD 14) (p < 0.001). The pain and functional subscales of the QLQ-BM22 also significantly improved at most times. A total of 12 devices broke, giving an unadjusted device fracture rate of 15%.

Conclusion: Stabilization with the IS decreased pain and improved function with consistent results during the first postoperative year. IS is a new, minimally invasive type of internal fixation. The use of the IS alone may be better for impending rather than completed pathological fractures, and may be better in completed fractures if an added plate or more than the usual number of locking screws is required. Caution is warranted regarding its use alone in patients with a completed pathological fracture due to the rate of breakage of the device.

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来源期刊
Bone & Joint Journal
Bone & Joint Journal ORTHOPEDICS-SURGERY
CiteScore
9.40
自引率
10.90%
发文量
318
期刊介绍: We welcome original articles from any part of the world. The papers are assessed by members of the Editorial Board and our international panel of expert reviewers, then either accepted for publication or rejected by the Editor. We receive over 2000 submissions each year and accept about 250 for publication, many after revisions recommended by the reviewers, editors or statistical advisers. A decision usually takes between six and eight weeks. Each paper is assessed by two reviewers with a special interest in the subject covered by the paper, and also by members of the editorial team. Controversial papers will be discussed at a full meeting of the Editorial Board. Publication is between four and six months after acceptance.
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