Collagen meniscus implant adequate to enhance meniscal function in chronic meniscal injury .
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):225 J Bone Joint Surg Am. 2008 Jul;90(7):1413-26.311 patients with an irreparable injury of the medial meniscus or a previous partial medial meniscectomy were divided into 2 study arms: acute arm with no prior surgery on the involved meniscus or the chronic arm with 1, 2 or 3 prior meniscal surgeries. Patients were randomized either to receive the collagen meniscus implant or to be treated with a partial meniscectomy only. Clinical follow-up examinations were performed for 2 years postoperatively, and patients were to complete validated questionnaires 7 years postoperatively. Patients allocated to receive the collagen meniscus implant also underwent 1-year second-look arthroscopy to assess tissue growth and quality. Results indicated that the collagen meniscus implant was found to support new tissue ingrowth, which was stable, safe, and biomechanically competent and improved meniscal function, as evident by the clinical outcomes in patients with a chronic meniscal injury.
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.
3/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
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?
Meniscal injuries lead to increased pain and limitation in clinical function and activity levels. The options in this field are very limited, with cadaver grafts having limited applications. The Biomaterials research evaluates the newer materials for collagen meniscus implant application and it is unclear whether such implant would have a clinical role in future. This study was needed to evaluate the efficacy of the collagen meniscus implant in chronic and acute patients.
Qual era a principal questão de investigação?
Does the application of collagen meniscus implant have superior clinical outcomes as compared to patients treated with partial medial meniscectomy alone, for irreparable injury of medial meniscus, as evaluated over 7 years?
- At 1 year, the 141 repeat arthroscopies that were performed revealed that the collagen meniscus implants had resulted in significantly increased meniscal tissue over that seen after the partial meniscectomy (p=0.001).
- The implant was found to flourish the meniscus-like matrix production and integration, as it was assimilated and resorbed.
- In the chronic study arm, the patients receiving meniscal implant significantly regained much of their lost activity than controls (p=0.02) and also underwent significantly lesser reoperations (p=0.04).
- No differences were observed between the two study groups in the acute arm.
De que é que me devo lembrar mais?
The collagen meniscus implant was found to support new tissue ingrowth, which was stable, safe, bio-mechanically competent and improved meniscal function, as evident by the improved clinical outcomes in patients with a chronic meniscal injury.
Como é que isto afectará o tratamento dos meus doentes?
The collagen meniscus implant has a potential future in replacing the irreparable or lost meniscal tissue and hence improving the quality of life in patients with chronic meniscal injury. Definitive determination of the effect of collagen meniscus implants should be achieved with future research.
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