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RCT
ACE Report #2722

Collagen meniscus implant adequate to enhance meniscal function in chronic meniscal injury


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:1

Comparison of the collagen meniscus implant with partial meniscectomy: A prospective randomized trial

J Bone Joint Surg Am. 2008 Jul;90(7):1413-26.

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Synopsis

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.

Publication Funding Details +
Funding:
Industry funded
Sponsor:
ReGen Biologics
Conflicts:
Other

Risk of Bias

5.5/10

Reporting Criteria

17/20

Fragility Index

N/A

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)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

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

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

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.

What was the principal research question?

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?

Study Characteristics -
Population:
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
Intervention:
Collagen meniscus implant Group: Patients underwent treatment for irreparable injury of medial meniscus with the collagen meniscus implant (Acute Group n=75; M65 F10) (Chronic Group n=85; M61 F24)
Comparison:
Partial meniscectomy Group: treated with a partial meniscectomy only (Acute Group n=82; M67 F15) (Chronic Group n=69; M50 F19)
Outcomes:
1 year arthroscopy; status of chondral surfaces assessed with Outerbridge score; Lysholm functional score and Tegner activity scale; Pain levels (VAS) assessed during rest; activities of daily living and at the highest levels of activity; re-operation rates; survival rates; adverse events.
Methods:
RCT: Prospective: Multi-centered (16): Non-Blinded
Time:
2 year evaluation, 7 year follow up (mean 59 month follow up, range 16-92 month)

What were the important findings?

  • 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.

What should I remember most?

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.

How will this affect the care of my patients?

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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