FOOT & ANKLE
Efficacy and complications of open and minimally invasive surgery in acute Achilles tendon rupture: a prospective randomised clinical study--preliminary report
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(8):12 Int Orthop. 2013 Apr;37(4):625-9. doi: 10.1007/s00264-012-1737-9. Epub 2012 Dec 19Fifty-one patients with acute Achilles tendon rupture were randomized to determine the comparative efficacy between minimally invasive surgery and traditional open surgery as treatment options. Follow-up was conducted for 24 months postoperatively. Results at final follow-up revealed that no patients in either group experienced a tendon re-rupture, while a similar number of infections was observed between groups. Measurements of clinical outcome were non-significantly different between groups.
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。
3/4
Randomization
2/4
Outcome Measurements
2/4
Inclusion / Exclusion
0/4
Therapy Description
3/4
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？
While there are numerous interventions currently available for acute Achilles tendon rupture, advocacy of the optimal treatment remains primarily subjective, with a lack of agreement from contrasting evidence. Although surgical treatment can effectively reduce the risk of ruptures, the probability of surgical complications remains the main downside when comparing with non-operative treatment. More specifically, there is an ongoing debate on the comparative efficacy between open surgery and minimally invasive procedures. Ideally, minimally invasive surgery should reduce the incidence of complications, while maintaining the functional benefits of surgical intervention; however, there have been contradictory results reporting on minimally invasive management of Achilles tendon ruptures.
主な研究課題は何ですか？
Does minimally invasive surgery with the Achillon device for Achilles tendon rupture provide a more efficacious outcome compared to open surgery, when measured over 24 months postoperatively?
重要な知見は？
- There were no incidents of Achilles tendon re-ruptures or sural nerve lesions in either group. Wound infections were developed in one patient of the MIS group and in two patients who underwent open surgery.
- Pain was similar between groups, with a mean 1.6 in the MIS group and 1.7 in the open surgery group at the last follow-up (P>0.05).
- Ankle dorsiflexion for the treated limb at final follow-up was measured at 14.2 deg (+/-5.1) in the MIS group and 12.6 deg (+/-4.2) in the open surgery group. Ankle plantar flexion for the treated limb was 39.6 deg (+/-8.1) and 41.6 deg (+/-10.8), respectively. Differences between groups for dorsiflexion and plantar flexion were non-significant (P=0.40 and 0.50, respectively).
- At 24 months, calf circumference for the treated limb did not significantly differ between groups, measured at 36.4 cm (+/-3.3) in the MIS group and 37.4 (+/-4.8) in the open surgery group (P=0.53). At that same time point calf strength was similar between groups through the single heel-rise test (P=0.33).
- Return to work, measured at 24 months, was similar between groups: 4.8 weeks (+/-2.2) in the MIS group and 5.5 weeks (+/-2.7) in the open surgery group. A similar number of patients in each group returned to their original activity level in both groups (46% overall returned to pre-injury status).
- Scar length was significantly shorter in the MIS group (4.0 +/- 0.9 cm) compared to the open surgery group (14.5 +/- 3.3 cm) (P=0.005). Two patients who underwent open surgery developed keloid formations, although were still graded as acceptable.
最も覚えておくべきことは？
Despite the low number of severe complications observed with the Achillon device minimally invasive procedure, the incidence was not significantly reduced compared to traditional open surgery with Krackow sutures. Scar length was shorter with the minimally invasive procedure; however, this result did not appear to impact patients' self-assessment of the scar aesthetics. Clinical outcome was similar between the two procedures.
それが私の患者ケアにどのように影響するか？
The return to pre-injury activity level in both groups was not as high as reported in previous literature, which was thought to be due to the non-weight bearing and immobilization protocol in the immediate postoperative period. It should also be noted that no formal physiotherapy protocol was administered. This goes to suggest that changes in the postoperative protocol (ie. early weight-bearing and mobilization) following the MIS procedure might reveal better results. The present study suggests that operative management of Achilles tendon rupture with minimally invasive surgery does not appear to elicit a more favorable outcome compared to open surgery.
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