ArticleInternational journal of spine surgery2021
Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results.
Article in International journal of spine surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 8 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 12 citations in OpenAlex.
- Long-Term Range of Motion and Influence on Clinical Outcomes After Lumbar Disc Replacement: A Systematic Review.Global spine journal · 2026Review
- Combined effect of artificial cervical disc replacement and facet tropism on the index-level facet joints: a finite element study.BMC musculoskeletal disorders · 2024Article
- Lumbar Total Disc Replacements for Degenerative Disc Disease: A Systematic Review of Outcomes With a Minimum of 5 years Follow-Up.Global spine journal · 2024Review
- The Decline of Lumbar Artificial Disc Replacement.Journal of spine research and surgery · 2024Article
- Lumbar arthroplasty for treatment of primary or recurrent lumbar disc herniation.International orthopaedics · 2023Article
- Usefulness of Detecting Brain-Derived Neurotrophic Factor in Intervertebral Disc Degeneration of the Lumbosacral Spine.Medical science monitor : international medical journal of experimental and clinical research · 2023Article
- Long-term outcomes following lumbar total disc replacement with M6-L.Journal of spine surgery (Hong Kong) · 2022Article
- Preserving spinal motion: lumbar disc arthroplasty in the US.Current orthopaedic practiceReview
Corrections and comments
- Erratum issuedCorrections.2023
Authors and funding
11 authors at 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis study compared 7-year safety and efficacy outcomes of activL and ProDisc-L lumbar total disc replacements in patients with symptomatic, single-level lumbar degenerative disc disease (DDD). The objectives are to report 7-year outcomes of the trial, evaluate the outcomes for patients lost to follow-up, and determine whether early outcomes predict long-term outcomes.
methodsThis was a prospective, multicenter, randomized, controlled investigational device exemption study. Eligible patients with symptomatic, single-level lumbar DDD had failed ≥6 months of nonsurgical management. Patients (
resultsAt 7 years, the activL group was noninferior to the ProDisc-L group on the primary composite endpoint (
conclusionsThe benefits of activL and ProDisc-L are maintained after 7 years, with significant improvements from baseline observed in pain, function, and opioid use. activL is more effective at preserving ROM than ProDisc-L and has a more favorable safety profile. Improvements in other primary and secondary outcomes were similar between both disc designs. LEVEL OF EVIDENCE: 1.
Indexed as
Identifiers
What OpenQuestion holds
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.