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Bioabsorbable arrows versus screws in meniscal repair

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Bioabsorbable arrows versus screws in meniscal repair

Vol: 2| Issue: 2| Number:81| ISSN#: 2564-2537
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

All-inside meniscal repair with bioabsorbable meniscal screws or with bioabsorbable meniscus arrows: A prospective, randomized clinical study with 2-year results

Am J Sports Med. 2010 Nov;38(11):2211-7.

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Synopsis

42 patients undergoing all-inside meniscal repair were randomized to be treated with bioabsorbable meniscal arrows or meniscal screws, with the hypothesis that similar clinical outcomes would be seen at short-term follow-up for meniscal repair. At an average follow-up time of 27 months, the clinical outcomes, measured Lysholm score and the International Knee Documentation Committee (IKDC) knee score, were similar, except the arrow group showed significantly greater chondral damage.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Competitive Research Funding of the Pirkanmaa Hospital District
Conflicts:
Other

Risk of Bias

7/10

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

3/4

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

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?

The recommended treatment for meniscal tears is to repair the tear and to save the menisci whenever possible. The focus now has shifted towards all-inside meniscal repair techniques.At present, there is a lack of prospective randomized clinical studies that compare these different all-inside meniscal repair devices. In a 2 year study period, this trial compared 2 such techniques: repair with the bioabsorbable Trinion meniscal screw and repair with the bioabsorbable meniscus arrow.

What was the principal research question?

Are there any differences in clinical and radiographic outcomes of an all inside meniscal repair with the use of bioabsorbable meniscal screw and bioabsorbable meniscal arrow 2 years after surgery?

Study Characteristics -
Population:
42 patients (age range 23 - 41) with traumatic longitudinal unstable meniscal tear in a red or red-white zone of the meniscus. 28 had isolated meniscal tears (12 in the screw group and 16 in the arrow group), and 14 had meniscal tears with anterior cruciate ligament (ACL) rupture (9 in the screw group, and 5 in the arrow group)
Intervention:
Meniscal Screw Group: All-inside meniscal repair with bioabsorbable meniscal screws was performed. There were 16 medial menisci and 7 lateral menisci in the screw group (n=21) M/F= 17/4, Mean age = 30 (+/-9) years
Comparison:
Meniscal Arrow Group: All-inside meniscal repair with bioabsorbable meniscal arrow was performed. There were 12 medial menisci and 11 lateral menisci in the arrow group (n=21) M/F=12/9, Mean age= 30 (+/-9) years
Outcomes:
Lysholm Knee Score, International Knee Documentation Committee (IKDC) Final and Functional Score (scale of 0-10 rating the subjective function of the knee). Clinical examination for the meniscus with McMurray's Test, joint-line tenderness, and the Appley test.
Methods:
RCT: Single Center: Prospective
Time:
2 years (mean follow up time for screw group was 27 (+/-9) months and for arrow group was 26 (+/-7) months)

What were the important findings?

  • The Lysholm score, the IKDC function score, and the IKDC final score reported no significant difference between the groups preoperatively and at the 2-year follow-up.
  • In the meniscal arrow group, mild chondral damage (grade I) was observed in 5 patients in the medial femoral condyle on the same side as the meniscal repair, while In the screw group, no chondral damage was observed (p = 0.008).
  • 17% of the screw group and 30% in the arrow group had failures (P = 0.242)
  • The meniscal healed in 14 patients (8 in the screw group and 6 in the arrow group), and as partially healed in 4 patients (3 in the screw group and 1 in the arrow group).
  • No significant differences were seen in tenderness in the joint line by McMurray test at 2 year follow up.
  • All knees were stable and similar proportion of patients were able to carry out same level sporting activity (15 vs 12) or at a lower level activity (2 in each group)

What should I remember most?

All-inside meniscal repair with bio-absorbable meniscal screws and arrows resulted in similar clinical outcomes. However, significantly more chondral damage was observed when patients received arrows for fixation. The authors discontinued the study for ethical reasons based on the observed chondral damage findings.

How will this affect the care of my patients?

According to the study findings, it was suggested that meniscal repair performed with bioabsorbable meniscal screws resulted in better results than the meniscal repair with bioabsorbable meniscus arrows. The use of meniscal arrows for fixation was associated with significant chondral damage.

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