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Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears.

ABSTRACT: PURPOSE:The 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. METHODS:This 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. RESULTS:The 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. CONCLUSIONS:Our 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 REGISTRATION:Eudra-CT, 2007-007630-19 . Registered on 30 January 2008. LEVEL OF EVIDENCE:A Level 1 of evidence treatment study.

SUBMITTER: Lamas JR

PROVIDER: S-EPMC6604436 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears.

Lamas José Ramón JR García-Fernández Carlos C Tornero-Esteban Pilar P Lópiz Yaiza Y Rodriguez-Rodriguez Luis L Ortega Luis L Fernández-Gutiérrez Benjamín B Marco Fernando F

Trials 20190701 1

<h4>Purpose</h4>The 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.<h4>Methods</h4>This 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 p ...[more]

PMID: 31262366

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Project description:BACKGROUND: The single-row and double-row fixation techniques have been widely used for rotator cuff tears. However, whether the double-row technique produces superior clinical or anatomic outcomes is still considered controversial. This study aims to use meta-analysis to compare the clinical and anatomical outcomes between the two techniques. METHODS: The Pubmed, Embase, and Cochrane library databases were searched for relevant studies published before November 1, 2012. Studies clearly reporting a comparison of the single-row and double-row techniques were selected. The Constant, ASES, and UCLA scale systems and the rotator cuff integrity rate were evaluated. The weighted mean differences and relative risks were calculated using a fixed-effects or random-effects model. RESULTS: Eight studies were included in this meta-analysis. The weighted mean differences of the ASES (-0.84; P?=?0.04; I(2)?=?0%) and UCLA (-0.75; P?=?0.007; I(2)?=?0%) scales were significantly low in the single-row group for full-thickness rotator cuff tears. For tear sizes smaller than 3 cm, no significant difference was found between the groups no matter in Constant (P?=?0.95; I(2)?=?0%), ASES (P?=?0.77; I(2)?=?0%), or UCLA (P?=?0.24; I(2)?=?13%) scales. For tear sizes larger than 3 cm, the ASES (-1.95; P?=?0.001; I(2)?=?49%) and UCLA (-1.17; P?=?0.006; I(2)?=?0%) scales were markedly lower in the single-row group. The integrity of the rotator cuff (0.81; P?=?0.0004; I(2)?=?10%) was greater and the partial thickness retear rate (1.93; P?=?0.007; I(2)?=?10%) was less in the double-row group. Full-thickness retears showed no difference between the groups (P?=?0.15; I(2)?=?0%). CONCLUSION: The meta-analysis suggests that the double-row fixation technique increases post-operative rotator cuff integrity and improves the clinical outcomes, especially for full-thickness rotator cuff tears larger than 3 cm. For tear sizes smaller than 3 cm, there was no difference in the clinical outcomes between the two techniques. LEVEL OF EVIDENCE: Level I.

Project description:BackgroundArthroscopic rotator cuff repair (ARCR) is among the most commonly performed orthopaedic procedures. Several factors-including age, sex, and tear severity-have been identified as predictors for outcome after repair. The influence of the tear etiology on functional and structural outcome remains controversial.PurposeTo investigate the influence of tear etiology (degenerative vs traumatic) on functional and structural outcomes in patients with supraspinatus tendon tears.Study designCohort study; Level of evidence, 2.MethodsPatients undergoing ARCR from 19 centers were prospectively enrolled between June 2020 and November 2021. Full-thickness, nonmassive tears involving the supraspinatus tendon were included. Tears were classified as degenerative (chronic shoulder pain, no history of trauma) or traumatic (acute, traumatic onset, no previous shoulder pain). Range of motion, strength, the Subjective Shoulder Value, the Oxford Shoulder Score (OSS), and the Constant-Murley Score (CMS) were assessed before (baseline) and 6 and 12 months after ARCR. The Subjective Shoulder Value and the OSS were also determined at the 24-month follow-up. Repair integrity after 12 months was documented, as well as additional surgeries up to the 24-month follow-up. Tear groups were compared using mixed models adjusted for potential confounding effects.ResultsFrom a cohort of 973 consecutive patients, 421 patients (degenerative tear, n = 230; traumatic tear, n = 191) met the inclusion criteria. The traumatic tear group had lower mean baseline OSS and CMS scores but significantly greater score changes 12 months after ARCR (OSS, 18 [SD, 8]; CMS, 34 [SD,18] vs degenerative: OSS, 15 [SD, 8]; CMS, 22 [SD, 15]) (P < .001) and significantly higher 12-month overall scores (OSS, 44 [SD, 5]; CMS, 79 [SD, 9] vs degenerative: OSS, 42 [SD, 7]; CMS, 76 [SD, 12]) (P≤ .006). At the 24-month follow-up, neither the OSS (degenerative, 44 [SD, 6]; traumatic, 45 [SD, 6]; P = .346) nor the rates of repair failure (degenerative, 14 [6.1%]; traumatic 12 [6.3%]; P = .934) and additional surgeries (7 [3%]; 7 [3.7%]; P = .723) differed between groups.ConclusionPatients with degenerative and traumatic full-thickness supraspinatus tendon tears who had ARCR show satisfactory short-term functional results. Although patients with traumatic tears have lower baseline functional scores, they rehabilitate over time and show comparable clinical results 1 year after ARCR. Similarly, degenerative and traumatic rotator cuff tears show comparable structural outcomes, which suggests that degenerated tendons retain healing potential.

Dataset Information

Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears.

Publications

Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears.

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