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)?
Sim = 1
Incerto = 0,5
Não relevante = 0
Não = 0
A Avaliação dos Critérios de Relato avalia a transparência com que os autores relatam as caraterísticas metodológicas e do ensaio na publicação. A avaliação está dividida em cinco categorias que são apresentadas de seguida.
2/4
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
O Índice de Fragilidade é uma ferramenta que auxilia na interpretação de achados significativos, fornecendo uma medida de força para um resultado. O Índice de Fragilidade representa o número de eventos consecutivos que precisam de ser adicionados a um resultado dicotómico para que o resultado deixe de ser significativo. Um número pequeno representa um resultado mais fraco e um número grande representa um resultado mais forte.
Porque é que este estudo era necessário agora?
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.
Qual era a principal questão de investigação?
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).
De que é que me devo lembrar mais?
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.
Como é que isto afectará o tratamento dos meus doentes?
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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