Evidence map›Paper›PMID 36862197›Full record

Trial reportKnee surgery, sports traumatology, arthroscopy : official journal of the ESSKA2023

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.

Martyn Snow, Jan Herman Kuiper, Steven James, Ellie Keeling, Sophie Rich, Priyadarshi Amit

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Delamination of rotator cuff tears impairs healing after repair: a systematic review and meta-analysis.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2023
    Pooled it
  4. Review
  5. [Interpretation of the 2025 American Academy of Orthopaedic Surgeons (AAOS) on Management of Rotator Cuff Injuries Evidence-Based Clinical Practice Guideline].Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery · 2026
    Article
  6. Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Martyn SnowArthroscopy division, Department of Arthroscopy, Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK B31 2AP, UK.
Jan Herman KuiperThe Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Oswestry, UK.
Steven JamesDepartment of Radiology, Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK.
Ellie KeelingArthroscopy division, Department of Arthroscopy, Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK B31 2AP, UK.
Sophie RichArthroscopy division, Department of Arthroscopy, Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK B31 2AP, UK.
Priyadarshi AmitArthroscopy division, Department of Arthroscopy, Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK B31 2AP, UK. drpamit@gmail.com.ORCID http://orcid.org/0000-0001-7029-8760

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe aims of this pilot randomised controlled trial (RCT) were to assess the safety and efficacy of a human dermal allograft patch and assess the feasibility of a future RCT comparing retear rate and functional outcome 12 months following standard and augmented double-row rotator cuff repair.

methodsA pilot RCT was conducted among patients undergoing arthroscopic repair of rotator cuff tear measuring between 1 and 5 cm. They were randomised to either augmented (double-row repair with human acellular dermal patch) or standard (double-row repair only). The primary outcome was rotator cuff retear determined on MRI scan at 12 months using the Sugaya's classification (grade 4 or 5). All adverse events were recorded. Functional assessment was performed at baseline and 3, 6, 9, and 12 months post-surgery using clinical outcome scores. Safety was assessed by complications and adverse effects, and feasibility by recruitment, follow-up rate and proof of concept statistical analyses of a future trial.

resultsBetween 2017 and 2019, 63 patients were considered for inclusion. Twenty-three patients were excluded, leaving 40 patients (20 per group) in the final study population. The mean tear sizes were 3.0 cm in the augmented and 2.4 cm in the standard group. There was one adhesive capsulitis in the augmented group, with no other adverse events. Retear was observed in 4/18 (22%) of patients in the augmented and 5/18 (28%) in the standard group. In both groups, functional outcome improved significantly which was clinically meaningful for all scores, with no difference between groups. Retear rate increased with tear size. Future trials are feasible but need a minimum total sample size of 150 patients.

conclusionClinically meaningful improved function without adverse effects was found with human acellular dermal patch-augmented cuff repairs. LEVEL OF EVIDENCE: Level II.

Indexed as

Rotator CuffRotator Cuff InjuriesArthroscopyHumansMagnetic Resonance ImagingPilot ProjectsRuptureTreatment OutcomeDermal patch allograftRetearRotator cuff repairRotator cuff tear

Identifiers

PMID36862197

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.