ArticleJB & JS open access
5-Year Results of an Implantable Shock Absorber Demonstrate Durable Outcomes in Patients with Medial Knee Osteoarthritis.
Article in JB & JS open access. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis
Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis, OUS
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0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The implantable shock absorber (ISA) addresses patients within the knee osteoarthritis treatment gap between failure of nonsurgical care and arthroplasty. Methods: This follow-up of a prospective, open-label, comparative cohort study reports effectiveness and safety outcomes at 5 years. Results: Eighty-one participants received the ISA. Participants had statistically significant improvement in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain (mean 43.4 point improvement, p < 0.0001) and function (mean 42.1 point improvement, p < 0.0001) versus baseline, beginning 6 weeks postsurgery, and remaining statistically significant and clinically meaningful through the 5-year follow-up. The study was designed to satisfy regulatory requirements, and survival was defined, a priori, in the study protocol with US Food and Drug Administration to be freedom from conversion to arthroplasty or high tibial osteotomy. At 5 years, 73/81 (90.1%) participants reported conversion-free survival. Conclusion: ISA provided benefits that were statistically significant and clinically meaningful for at least 5 years. Based on these 5-year data of durable, conversion-free survivorship, the ISA has proven to be a treatment option for medial knee osteoarthritis patients.
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.