Femoral tunnel enlargement reduced with autologous ruptured tissue vs conventional DB ACLR .
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original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(11):40 Arthroscopy. 2014 Apr;30(4):468-74. doi: 10.1016/j.arthro.2013.12.014.10 patients with ACL deficiencies were randomized to undergo double-bundle ACLR with either autologous ruptured ACL tissue sutured to grafts or conventional grafts, to compare magnitude of tunnel enlargement and clinical outcomes. Results indicated a significant decrease in femoral tunnel enlargement between groups, favouring the ruptured tissue group. Tibial tunnel enlargement ratios were similar between groups. Clinical outcomes were also not 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)?
Ja = 1
Ungewiss = 0.5
Nicht relevant = 0
Nein = 0
Die Bewertung der Berichtskriterien bewertet die Transparenz, mit der die Autoren die methodischen und studienspezifischen Merkmale der Studie in der Veröffentlichung angeben. Die Bewertung ist in fünf Kategorien unterteilt, die im Folgenden vorgestellt werden.
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Randomization
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Outcome Measurements
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Inclusion / Exclusion
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Therapy Description
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Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Der Fragilitätsindex ist ein Instrument, das bei der Interpretation signifikanter Ergebnisse hilft und ein Maß für die Stärke eines Ergebnisses liefert. Der Fragilitätsindex gibt die Anzahl der aufeinanderfolgenden Ereignisse an, die zu einem dichotomen Ergebnis hinzugefügt werden müssen, damit das Ergebnis nicht mehr signifikant ist. Eine kleine Zahl steht für ein schwächeres Ergebnis und eine große Zahl für ein stärkeres Ergebnis.
Warum wurde diese Studie jetzt benötigt?
Recent developments in anterior cruciate reconstruction have focused on achieving anatomic reduction of the AM and PL bundles with hamstring grafts. However, while patients enjoy favourable outcomes, treatment can lead to significant tunnel enlargement and complicate ACL revision surgeries in the long-term. Recently, researchers have observed properties of tendon-bone healing in ruptured ACL tissue (i.e. CD34+ cells). Applications in animal studies have demonstrated a capacity for healing and ability to reduce magnitude of tunnel widening. This study aimed to pilot a technique that utilizes autologous rupture ACL tissue as a graft in a human clinical study.
Was war die wichtigste Forschungsfrage?
Does the use of a graft, with autologous ruptured ACL tissue sutured to its ends, in anterior cruciate ligament reconstruction decrease tunnel enlargement and improve clinical results when compared to conventional ACLR, 2 years after treatment intervention?
- Tunnel enlargement was significantly less in the ruptured tissue group compared to the conventional (control) group in both femoral tunnels (AM and PL). Femoral AM tunnel enlargement ratios were 84.6% +/- 15.9 and 119.5% +/- 24.1 in the ruptured tissue and control groups respectively (p=0.0283). Ratios for the PL tunnel were 84.2% +/ -14.0 compared to 151.3% +/- 23.8, respectively (p=0.0090).
- Tunnel enlargement for femoral AM and PL tunnels were not significantly different between groups. Enlargement ratios for tibial AM tunnel were 71.0% +/- 11.2% versus 77.8% +/- 15.4% for the ruptured tissue group and control group, respectively, and 65.8% +/- 10.8% versus 96.9% +/- 30.5 for the PL tunnel (p>0.05 for both comparisons).
- Clinical outcome measures at 2 years postoperative did not differ significantly between the ruptured tissue group and control group: Mean Lysholm scores were 92.6 vs 93.0, respectively, anterior knee stability 1.4 vs 1.0, and pivot-shift test results 4/5 in both groups (p>0.05 for all).
Was sollte ich mir besonders merken?
Tunnel enlargement of the femoral AM and PL tunnels were both significantly reduced in the ruptured tissue group compared to the conventional group. Tibial tunnel enlargement was comparable between techniques. Additionally, Lysholm scores, anterior knee stability, and pivot-shift tests were not significantly different between groups.
Wie wird sich dies auf die Behandlung meiner Patienten auswirken?
Double-bundle ACLR using grafts of autologous ruptured ACL tissue sutured to doubled semitendinosus tendons appeared to yield less femoral tunnel widening while providing similar clinical outcomes when compared to a conventional technique. Findings from this pilot study warrant larger next-phase trials in populations of a wider age range. Additionally, further research is needed to elicit the healing mechanism of this technique.
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