Comparison of injectable collagen medical device vs. hyaluronate for knee osteoarthritis .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(21):10 BMC Musculoskelet Disord. 2016 Feb 22;17(1):9464 patients with mild-moderate knee osteoarthritis were randomized to intra-articular injection of either sodium hyaluronate (SUPARTZ; Seikagaku) or a new collagen medical device (MD-Knee; Guna S.p.a). The purpose of this study was to compare the two groups based on function and knee pain over 6 month follow-up. Results demonstrated no significant differences in either knee function or pain scores at 3 or 6 months after enrollment. Additionally, there were no significant differences between groups in general health-related quality of life, or the rate of patients who required additional acetaminophen.
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.
2/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
3/4
Therapy Description
3/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
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?
The topic of conservative management of knee osteoarthritis has been debated significantly in recent years. One of the most prominent treatment methods as of late is the intra-articular injection of sodium hyaluronate (HA). Another more recent intra-articular treatment that has been developed is the use of a collagen medical device (MD-Knee; Guna S.p.a), though its efficacy has yet to be tested in a randomized controlled trial.
Was war die wichtigste Forschungsfrage?
What are the effects of a collagen medical device (MD-Knee; Guna S.p.a) compared to intra-articular injection of sodium hyaluronate (SUPARTZ; Seikagaku) in patients with mild-moderate knee osteoarthritis, assessed over 6 month follow-up after enrollment?
- At 3 months (primary endpoint), there was no significant difference in mean Lequesne Knee Index between the MD-Knee group (8.59 +/- 4.71) and the SUPARTZ group (9.79 +/- 4.43) (p=0.330). There was also no significant difference between groups in improvement in mean LKI from baseline to 3 months (p=0.368).
- At 6 months, there was also no significant difference in mean LKI between the MD-Knee group (9.12 +/- 3.89) and the SUPARTZ group (9.28 +/- 4.28) (p=0.621).
- There were no significant differences between the MD-Knee group and SUPARTZ group at 6 months for either VAS pain (5.42 +/- 2.69 vs. 4.43 +/- 2.63, respectively; p=0.275) or SF-36 scores (88.37 +/- 28.83 vs. 92.07 +/- 23.37, respectively; p=0.462).
- Additional analgesic consumption (acetaminophen) occurred in 12/31 (38.7%) in the MD-Knee group and 13/29 (44.8%) in the SUPARTZ group.
- One patient in the MD-Knee discontinued treatment due to a moderate post-injection reaction.
Was sollte ich mir besonders merken?
In the treatment of mild-moderate knee osteoarthritis, there was no significant difference in knee function or pain over 6 month follow-up between intra-articular administration of a collagen medical device (MD-Knee; Guna S.p.a) or sodium hyaluronate (SUPARTZ; Seikagaku). Additional analgesics were still needed by approximately 40% of patients.
Wie wird sich dies auf die Behandlung meiner Patienten auswirken?
The results of this study suggest that the newly developed collagen medical device may offer short-term results similar to sodium hyaluronate in knee osteoarthritis treatment. However, as there is still controversy regarding the clinical efficacy of hyaluronate products in knee osteoarthritis treatment, and there was no placebo group included in the current study, additional placebo-controlled trials are necessary to more adequately assess the clinical efficacy of the collagen medical device within this patient population.
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