Trial reportTrials2019
Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears.
Trial report in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.
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
24 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Retear rates after rotator cuff surgery: a systematic review and meta-analysis.BMC musculoskeletal disorders · 2021Pooled it
- Use of implantable meshes for augmented rotator cuff repair: a systematic review and meta-analysis.BMJ open · 2020Pooled it
- Management of partial-thickness rotator cuff tears with autologous adipose-derived regenerative cells is safe and more effective than injection of corticosteroid.Scientific reports · 2023Trial
- A pilot randomised controlled trial assessing standard versus dermal patch-augmented rotator cuff repair found no adverse effects and suggest future trials need a minimum of 150 patients.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2023Trial
- Updates in ultrasound-guided musculoskeletal interventions.The British journal of radiology · 2026Review
- Histologic outcomes of rotator cuff patch augmentation: a literature review.JSES reviews, reports, and techniques · 2026Review
- Rotator cuff disease, repair and augmentation.Bulletin of the Hospital for Joint Disease (2013) · 2026Review
- Grafts in tendon repair.Materials today. Bio · 2026Review
- Rotator cuff repair and biologic augmentation-what do we know?JSES reviews, reports, and techniques · 2026Review
- Histological and genetic changes induced by extracorporeal shockwave therapy after rotator cuff repair in a rat model with tears.Scientific reports · 2026Article
- Stem cell approaches for tendon repair: delusion or insight.The Journal of physiology · 2025Review
- Poor consideration of tissue loading in randomised trials of MSC interventions for tendon pathology: A systematic review using the TIDieR framework.Journal of experimental orthopaedics · 2025Review
- State-of the-art and future perspective in co-culture systems for tendon engineering.Biomaterials and biosystems · 2025Article
- Recent advances in pericardium extracellular matrix for tissue regeneration, along with a short insight into artificial intelligence.Frontiers in medical technology · 2025Review
- Advancements in Therapeutic Approaches for Degenerative Tendinopathy: Evaluating Efficacy and Challenges.International journal of molecular sciences · 2024Review
- Optimization of transplantation methods using isolated mesenchymal stem/stromal cells: clinical trials of inflammatory bowel diseases as an example.Inflammation and regeneration · 2024Article
- Impact of surrogate outcomes in randomized controlled trials for shoulder rotator cuff tears.Archives of orthopaedic and trauma surgery · 2023Article
- MESENCHYMAL CELLS IN ROTATOR CUFF REPAIR - TECHNIQUE DESCRIPTION AND CASE REPORTS.Acta ortopedica brasileira · 2023Article
- An overview of the material science and knowledge of nanomedicine, bioscaffolds, and tissue engineering for tendon restoration.Frontiers in bioengineering and biotechnology · 2023Review
- Cell therapy efficacy and safety in treating tendon disorders: a systemic review of clinical studies.Journal of experimental orthopaedics · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
purposeThe purpose of the study was to compare the safety and efficacy of autologous mesenchymal stem cells (MSCs) embedded in a xenogenic scaffold for repairing the supraspinatus tendon.
methodsThis was a randomized, double-blind and placebo-controlled trial evaluating patients with full-thickness rotator cuff tears (Eudra-CT, 2007-007630-19). Effectiveness was evaluated using the Constant score and a visual analogue pain scale (VAS). Constant score has four domains including pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability). The structural integrity of the repaired tendon was assessed by magnetic resonance imaging (MRI) according to Patte and Thomazeau classification criteria. The primary study end point was an improvement in the Constant score by 20 points at one year compared to initial assessment.
resultsThe trial was stopped due to adverse effects observed in both groups. Only thirteen patients were included and analyzed. The Constant questionnaire showed a significant improvement in the MSC treatment group compared with the preoperative data (p = 0.0073). Secondary outcome measures were similar in both groups.
conclusionsOur study showed preliminary inconclusive clinical outcomes in the patients treated with MSCs. Adverse events revealed the need for further approaches using scaffolds of a different nature or perhaps no scaffolds, in the context of small joints.
trial registrationEudra-CT, 2007-007630-19 . Registered on 30 January 2008. LEVEL OF EVIDENCE: A Level 1 of evidence treatment study.
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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.