Abstract:
PURPOSE:To evaluate the safety and efficacy of a novel technique of preconditioning autologous blood with gold particles (GOLDIC®) and injection in patients with moderate to severe knee osteoarthritis (KOA). METHODS:During this phase 2a, proof-of-concept (PoC) open label study, 83 consecutive patients that 64 patients met inclusion criteria (mean age: 64.8 years; 89 knees) with radiographically proven KOA, received four ultrasound guided intra-articular knee injections of GOLDIC® at three to six day intervals. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee injury and Osteoarthritis Outcome Score (KOOS) were evaluated at baseline, four weeks, three, six months, one, two and four years (T1-T6). The incidence of treatment related severe adverse events (SAEs) recorded. Intra-articular gelsolin level in patients with effusion was determined. RESULTS:KOOS and WOMAC scores improved for the full duration of the study (P < 0.05), minimal clinically important difference (MCID) was observed at all time points in all KOOS subscores, with no reported SAEs. Intra-articular gelsolin level increased after treatment with reduction of effusion. No statistically significant evidence of an association between patient demographics and outcome were identified. Nine patients failed treatment, with 32 months mean time to failure and underwent total knee arthroplasty. CONCLUSION:PoC study of GOLDIC® as a novel device for conservative management of moderate to severe KOA was confirmed. GOLDIC® produces rapid and sustained improvements in all indices after treatment, with no SAEs. TRIAL REGISTRATION:§ 13 Abs.2b AMG Bavaria (Protokol Reg OBB 5-16) (Ref 53.2-2677.Ph_3-67-2)-Date 3/20/2010 retrospectively registered.
journal_name
Int Orthopjournal_title
International orthopaedicsauthors
Schneider U,Kumar A,Murrell W,Ezekwesili A,Yurdi NA,Maffulli Ndoi
10.1007/s00264-020-04870-wsubject
Has Abstractpub_date
2021-02-01 00:00:00pages
497-507issue
2eissn
0341-2695issn
1432-5195pii
10.1007/s00264-020-04870-wjournal_volume
45pub_type
杂志文章abstract:PURPOSE:We evaluated the clinical efficacy and feasibility of one-stage posterior internal fixation, debridement and interbody thoracic fusion in the treatment of thoracic tuberculosis. METHODS:Sixty adult patients with monosegmental thoracic tuberculosis were studied retrospectively: 34 men and 26 women with an avera...
journal_title:International orthopaedics
pub_type: 杂志文章
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更新日期:2012-02-01 00:00:00
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journal_title:International orthopaedics
pub_type: 杂志文章
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更新日期:2012-03-01 00:00:00
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更新日期:2019-05-01 00:00:00
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journal_title:International orthopaedics
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journal_title:International orthopaedics
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更新日期:1995-01-01 00:00:00
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journal_title:International orthopaedics
pub_type: 杂志文章
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journal_title:International orthopaedics
pub_type: 杂志文章
doi:10.1007/BF00181106
更新日期:1995-01-01 00:00:00
abstract:PURPOSE:Although injuries sustained during ice skating have been reported to be more serious than other forms of skating, the potential injury risks are often underestimated by skating participants. The purpose of this study was to give a descriptive overview of injury patterns occurring during ice skating. Special emp...
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更新日期:2015-01-01 00:00:00
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更新日期:2016-05-01 00:00:00
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更新日期:2014-11-01 00:00:00
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更新日期:2019-01-01 00:00:00
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journal_title:International orthopaedics
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doi:10.1007/BF00266074
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更新日期:2019-04-01 00:00:00
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更新日期:2019-11-01 00:00:00
abstract::We evaluated the pre- and postoperative neurological state of 3 patients with lumbar intradural lipoma. Total resection of the lipoma in the cauda equina was impossible, and partial resection and expansive laminoplasty was carried out. Subsequent neural involvement may depend on the duration of symptoms rather than th...
journal_title:International orthopaedics
pub_type: 杂志文章
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更新日期:1997-01-01 00:00:00
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journal_title:International orthopaedics
pub_type: 杂志文章
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更新日期:2014-04-01 00:00:00
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journal_title:International orthopaedics
pub_type: 杂志文章
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更新日期:2006-06-01 00:00:00