An assessment of quality of randomized controlled trials in shoulder instability surgery using a modification of the clear CLEAR-NPT score

Abstract

Background

The present study aimed to evaluate the methodological quality and determine the quality of reporting of randomized controlled trials (RCTs) that assess surgical treatment for shoulder instability.

Methods

A Cochrane, Pubmed, EMBASE and Trip database search was performed, including the relevant literature, regarding RCTs that report on shoulder instability published between January 1994 and January 2017. Methodological quality was assessed with a modification of the Checklist to Evaluate A Report of a Nonpharmacologic Trial (CLEAR-NPT). Points were assigned based on 18 items regarding patient characteristics, randomization, care provider characteristics, surgical details and blinding, with a total score ranging from 0 points to 18 points. Missing items were verified with the corresponding authors of the studies. Quality of reporting corresponds to the total scores including the items that were additionally provided by the authors.

Results

We included 22 studies. Of these, nine corresponding authors provided additional information. The average methodological quality was 16.9 points (11 studies) and the average quality of reporting was 9.5 points (22 studies). Items scoring worst included information regarding the surgeon’s experience, the patients’ level of activity, comorbidities, analyzing according to ‘intention-to-treat’ principles, and blinding of care providers, participants and assessors.

Conclusions

RCTs reporting on shoulder instability surgery are well performed but poorly reported.

Keywords

glenohumeral instability quality reporting shoulder

Get full access to this article

View all access options for this article.

References

Poojary

Bagadia

. Reviewing literature for research: doing it the right way. Indian J Sex Transm Dis 2014; 35: 85–91.

Viera

Bangdiwala

. Eliminating bias in randomized controlled trials: importance of allocation concealment and masking. Fam Med 2007; 39: 132–137.

Boutron

Moher

Tugwell

et al.

A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus. J Clin Epidemiol 2005; 58: 1233–1240.

Hammond

Queale

Kim

et al.

Surgeon experience and clinical and economic outcomes for shoulder arthroplasty. J Bone Joint Surg Am 2003; 85A: 2318–2324.

Hoppe

de Sa

Simunovic

et al.

The learning curve for hip arthroscopy: a systematic review. Arthroscopy 2014; 30: 389–397.

Jain

Pietrobon

Hocker

et al.

The relationship between surgeon and hospital volume and outcomes for shoulder arthroplasty. J Bone Joint Surg Am 2004; 86A: 496–505.

Nunley

Zhu

Brooks

et al.

The learning curve for adopting hip resurfacing among hip specialists. Clin Orthop Relat Res 2010; 468: 382–391.

Park

Lee

Bin Seok

et al.

Perioperative surgical complications and learning curve associated with minimally invasive transforaminal lumbar interbody fusion: a single-institute experience. CiOS Clin Orthop Surg 2015; 7: 91–96.

Spaans

van den Hout

JAAM

Bolder

SBT

. High complication rate in the early experience of minimally invasive total hip arthroplasty by the direct anterior approach. Acta Orthop 2012; 83: 342–346.

10.

O’Neill

. Arthroscopic Bankart repair of anterior detachments of the glenoid labrum. A prospective study. J Bone Joint Surg Am 1999; 81: 1357–1366.

11.

Cho

Hwang

Rhee

. Arthroscopic stabilization in anterior shoulder instability: collision athletes versus noncollision athletes. Arthrosc – J Arthrosc Relat Surg 2006; 22: 947–953.

12.

Hayashida

Yoneda

Nakagawa

et al.

Arthroscopic Bankart suture repair for traumatic anterior shoulder instability: Analysis of the causes of a recurrence. Arthroscopy 1998; 14: 295–301.

13.

Kim

Jung

et al.

Accelerated rehabilitation after arthroscopic Bankart repair for selected cases: a prospective randomized clinical study. Arthrosc – J Arthrosc Relat Surg 2003; 19: 722–731.

14.

Somford

Deurzen DFP

van

Ostendorf

et al.

Quality of research and quality of reporting in elbow surgery trials. J Shoulder Elb Surg 2015; 24: 1619–1626.

15.

van Oldenrijk

van Berkel

Kerkhoffs

GMMJ

et al.

Do authors report surgical expertise in open spine surgery related randomized controlled trials? A systematic review on quality of reporting. Spine (Phila Pa 1976) 2013; 38: 857–864.

16.

Arciero

Wheeler

Ryan

et al.

Arthroscopic Bankart repair versus nonoperative treatment for acute, initial anterior shoulder dislocations. Am J Sports Med 1994; 22: 589–594.

17.

Luo

Poehling

Freehill

. Review of Arciero’s article (1994) on arthroscopic Bankart repair versus non-operative treatment for acute, initial anterior shoulder dislocations: does the same hold true in 2016? J ISAKOS Jt Disord Orthop Sport Med 2016; 1: 358–364.

18.

Netto

Tamaoki

MJS

Lenza

et al.

Treatment of Bankart lesions in traumatic anterior instability of the shoulder: a randomized controlled trial comparing arthroscopy and open techniques. Arthrosc – J Arthrosc Relat Surg 2012; 28: 900–908.

19.

Bottoni

Smith

Berkowitz

et al.

Arthroscopic versus open shoulder stabilization for recurrent anterior instability: a prospective randomized clinical trial. Am J Sports Med 2006; 34: 1730–1737.

20.

Castagna

Borroni

Delle Rose

et al.

Effects of posterior-inferior capsular plications in range of motion in arthroscopic anterior Bankart repair: a prospective randomized clinical study. Knee Surg Sports Traumatol Arthrosc 2009; 17: 188–194.

21.

Elmlund

Kartus

Rostgård-Christensen

et al.

A 7-year prospective, randomized, clinical, and radiographic study after arthroscopic Bankart reconstruction using 2 different types of absorbable tack. Am J Sports Med 2009; 37: 1930–1937.

22.

Fabbriciani

Milano

Demontis

et al.

Arthroscopic versus open treatment of bankart lesion of the shoulder: a prospective randomized study. Arthrosc – J Arthrosc Relat Surg 2004; 20: 456–462.

23.

Hiemstra

Sasyniuk

Mohtadi

NGH

et al.

Shoulder strength after open versus arthroscopic stabilization. Am J Sports Med 2008; 36: 861–867.

24.

Jorgensen

Svend-Hansen

Bak

et al.

Recurrent post-traumatic anterior shoulder dislocation – open versus arthroscopic repair. Knee Surg Sports Traumatol Arthrosc 1999; 7: 118–124.

25.

Magnusson

Ejerhed

Rostgard-Christensen

et al.

A prospective, randomized, clinical and radiographic study after arthroscopic Bankart reconstruction using 2 different types of absorbable tacks. Arthroscopy 2006; 22: 143–151.

26.

Mahiroğulları

Ozkan

Akyüz

et al.

Comparison between the results of open and arthroscopic repair of isolated traumatic anterior instability of the shoulder. Acta Orthop Traumatol Turc 2010; 44: 180–185.

27.

McRae

Leiter

Subramanian

et al.

Randomized controlled trial of arthroscopic electrothermal capsulorrhaphy with Bankart repair and isolated arthroscopic Bankart repair. Knee Surg Sports Traumatol Arthrosc 2015; 24: 414–421.

28.

Milano

Grasso

Santagada

et al.

Comparison between metal and biodegradable suture anchors in the arthroscopic treatment of traumatic anterior shoulder instability: a prospective randomized study. Knee Surg Sports Traumatol Arthrosc 2010; 18: 1785–1791.

29.

Mohtadi

NGH

Chan

Hollinshead

et al.

A randomized clinical trial comparing open and arthroscopic stabilization for recurrent traumatic anterior shoulder instability: two-year follow-up with disease-specific quality-of-life outcomes. J Bone Joint Surg Am 2014; 96: 353–360.

30.

Monteiro

Ejnisman

Andreoli

et al.

Absorbable versus nonabsorbable sutures for the arthroscopic treatment of anterior shoulder instability in athletes: a prospective randomized study. Arthroscopy 2008; 24: 697–703.

31.

Norlin

Bankart

et al.

Use of Mitek anchoring for Bankart repair: a comparative, randomized, prospective study with traditional bone sutures. J Shoulder Elbow Surg 1994; 3: 381–385.

32.

Owens

Cameron

Peck

et al.

Arthroscopic versus open stabilization for anterior shoulder subluxations. Orthop J Sport Med 2015; 3: 1–4.

33.

Rhee

Lim

Cho

. Muscle strength after anterior shoulder stabilization: arthroscopic versus open Bankart repair. Am J Sports Med 2007; 35: 1859–1864.

34.

Robinson

. Primary arthroscopic stabilization for a first-time anterior dislocation of the shoulder. A randomized, double-blind trial. J Bone Jt Surg 2008; 90: 708–708.

35.

Salomonsson

Abbaszadegan

Revay

et al.

The Bankart repair versus the Putti-Platt procedure: a randomized study with WOSI score at 10-year follow-up in 62 patients. Acta Orthop 2009; 80: 351–356.

36.

Sperber

Hamberg

Karlsson

et al.

Comparison of an arthroscopic and an open procedure for posttraumatic instability of the shoulder: a prospective, randomized multicenter study. J Shoulder Elb Surg 2001; 10: 105–108.

37.

Tan

Guisasola

Machani

et al.

Arthroscopic stabilization of the shoulder: a prospective randomized study of absorbable versus nonabsorbable suture anchors. Arthrosc – J Arthrosc Relat Surg 2006; 22: 716–720.

38.

Warme

Arciero

Savoie

III et al.

Nonabsorbable versus absorbable suture anchors for open Bankart repair. A prospective, randomized comparison. Am J Sports Med 1999; 27: 742–746.

39.

Zarezade

Dehghani

Rozati

et al.

Comparison of Bristow procedure and Bankart arthroscopic method as the treatment of recurrent shoulder instability. Adv Biomed Res 2014; 12: 256–256.

40.

Altman

. Better reporting of randomised controlled trials: the CONSORT statement. Bmj 1996; 313: 570–571.

41.

Moher

Schulz

Altman

. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001; 357: 1191–1194.

42.

Plint

Moher

Morrison

et al.

Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 2006; 185: 263–267.

43.

Higgins

JPT

Sterne

JA.

Savović

et al.

A revised tool for assessing risk of bias in randomized trials. Cochrane Database Syst Rev 2016; 10: CD201601–CD201601.

44.

Jacquier

Boutron

Moher

et al.

The reporting of randomized clinical trials using a surgical intervention is in need of immediate improvement: a systematic review. Ann Surg 2006; 244: 677–683.

45.

Balasubramanian

Wiener

Alshameeri

et al.

Standards of reporting of randomized controlled trials in general surgery: can we do better?

Ann Surg 2006; 244: 663–667.

46.

Poolman

Struijs

PAA

Krips

et al.

Reporting of outcomes in orthopaedic randomized trials: does blinding of outcome assessors matter?

J Bone Joint Surg Am 2007; 89: 550–558.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.10 MB