FOOT & ANKLE
Stable Surgical Repair With Accelerated Rehabilitation Versus Nonsurgical Treatment for Acute Achilles Tendon Ruptures
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これにより、臨床的に意義のある研究をより早く認識することが可能になり、読者は将来の診療を形成する可能性が最も高い論文に集中することができます。
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(4):10 Am J Sports Med. 2013 Dec;41(12):2867-76. doi: 10.1177/0363546513503282. Epub 2013 Sep 6.101 patients with an acute Achilles tendon rupture were randomized to one of two groups: a surgical group, wherein surgical repair was performed and early weight-bearing was encouraged, or a non-surgical group, wherein patients were treated conservatively and early weight-bearing was also encouraged. The purpose of this study was to evaluate these two treatment methods with respect to functional outcomes. Results indicated that patients in the surgical group were not significantly different than the non-surgical group with respect to function, physical activity levels post-injury, quality of life, and the incidence of re-ruptures.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実=0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
3/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか?
Currently, evidence regarding the optimal form of treatment for acute Achilles tendon ruptures is conflicting. In particular, topics such as surgical versus conservative treatment, early versus delayed loading, and mobilization of the tendon following surgery contribute to this ongoing debate. Adding even more complexity to the issue, outcomes that are traditionally reported include the incidence of re-ruptures; however, recent evidence suggests more emphasis should be placed on functional recovery, rather than the occurrence of these complications. Therefore, this study was needed to compare whether surgical repair with early tendon loading and range of motion was more beneficial in terms of functional and patient-reported outcomes than traditional conservative treatment for acute Achilles tendon rupture.
主な研究課題は何ですか?
Over a period of 1 year, did surgical repair with early tendon loading and range of motion yield better functional and patient-reported outcomes in patients with acute Achilles tendon ruptures when compared to traditional non-surgical treatment methods?
重要な知見は?
- Median ATRS scores significantly improved over time in both groups at the 3, 6 and 12 month follow-up time periods (p<0.001), however there was no significant difference in ATRS scores between the surgical and non-surgical groups at any time point (p>0.05).
- Physical activity levels at 12 months post-operation, measured using the PAS questionnaire, were not significantly different from baseline in both the surgical group (p=0.78) and the non-surgical group (p=0.23).
- The activities of daily living (ADL) and sport and recreation subscores of the FAOS significantly improved over time between all time frames (p<0.05), except for the ADL subscore between 6 and 12 months in the surgical group (p=0.10). There were no significant between-group differences in median FAOS ADL and sport and recreation subscores at 3 months (p=0.42 and p=0.24, respectively).
- The quality of life (QOL) subscore of the FAOS significantly improved over time in both groups between all time frames (p<0.001). There were no significant between-group differences in median FAOS QOL subscores at 3 months (p=0.10).
- Compared to baseline, quality of life measured by the EQ-5D was significantly decreased at 12 months in both the surgical and non-surgical groups (both p=0.03), however there was no significant difference between groups at this time point (p=0.30).
- Except for concentric and eccentric power at 6 months, limb symmetry index (LSI) values were higher in the surgical group compared to the non-surgical group at all time points. However all of these differences, except for hopping and the drop counter-movement jump test at 12 months (p<0.05), were not considered statistically significant (p>0.05).
- 0 patients in the surgical group and 5 patients in the non-surgical group (10%) suffered a re-rupture (between 5 and 12 weeks post-injury) (p=0.06), although 1 patient in the surgical group suffered a partial re-rupture. Following subsequent surgery on those with re-ruptures, there was no significant difference in all functional test scores between those who suffered from a re-rupture and those who did not at 6 and 12 months (p>0.05), except for the heel-rise height at 6 months (p=0.011).
- 1 patient (2%) in the surgical group and 2 patients (4%) in the non-surgical group suffered a deep vein thrombosis. A superficial wound infection occurred in 12% of the patients in the surgical group (6 patients) and a persistent partial sural nerve disturbance occurred in 1 patient from the surgical group.
最も覚えておくべきことは?
Surgical repair of an acute Achilles tendon rupture with early full weight-bearing, range of motion and strength training was not found to be statistically superior to non-surgical treatment with immediate weight-bearing, with respect to function, physical activity levels post-injury, quality of life, and the incidence of re-ruptures. It was also found that for those who suffered a re-rupture and underwent subsequent surgical repair, most functional scores measured at 6 and 12 months were not significantly different than those of patients who did not suffer a re-rupture.
それが私の患者ケアにどのように影響するか?
The results from this study suggest that surgical repair for acute Achilles tendon ruptures with immediate full weight-bearing and range of motion is well tolerated, but is not superior to non-surgical treatment with early weight-bearing. This lack of significance, however, may be attributable to type II error. Therefore, optimal treatment should be specific to the individual and their specific goals. Future research could assess this correlation more accurately by quantitatively measuring the amount of time patients actually spent bearing their weight post-injury, instead of simply encouraging the patients to immediately bear their full weight post-injury.
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