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RCT
ACE Report #10006

Assessing the efficacy of postoperative PRP injections following arthroscopic supraspinatus repair


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:1

A Midterm Evaluation of Postoperative Platelet-Rich Plasma Injections on Arthroscopic Supraspinatus Repair: A Randomized Controlled Trial

Am J Sports Med. 2017 Nov;45(13):2965-2974

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Synopsis

60 patients with an isolated, full-thickness supraspinatus tear were randomized to either receive two postoperative ultrasound-guided injections of platelet-rich plasma or to no adjunct postoperative intervention. Patients were evaluated over a mean of 3.5 years for MRI (Sugaya classification) and clinical outcomes (QuickDASH, Oxford Shoulder Score, and Constant Score). At a mean of 3.5 years, there were no significant differences in clinical scores between groups, with the exception of a greater score on the abduction subscale of the Constant score in the PRP group. MRI outcomes were similar between groups at final follow-up.

Publication Funding Details +
Funding:
Industry funded
Sponsor:
Arthrex
Conflicts:
Other

Risk of Bias

6.5/10

Reporting Criteria

19/21

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

4/4

Randomization

3/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

4/5

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

Arthroscopic repair of a rotator cuff tear, though often clinically effective, suffers from a fairly high rate of retear. Platelet-rich plasma, applied either intraoperatively or as a postoperative injection, has been suggested to improve tendon healing and reduce the rate of retear. While a number of trials have reported short-term outcomes following the use of adjunct PRP therapy, few trials have provided medium-term follow-up.

What was the principal research question?

In arthroscopic supraspinatus repair, do postoperative injections of platelet-rich plasma at 7 and 14 days after surgery result in a significantly lower rate of tendon retear on MRI, over an average of 42 months of follow-up, when compared to patients who were not administered postoperative injections?

Study Characteristics -
Population:
60 patients with an isolated, full-thickness supraspinatus tear scheduled for arthroscopic repair. All cases were completed using a double-row, suture-bridge repair.
Intervention:
PRP group: At 7 and 14 days, patients were administered an ultrasound-guided injection of platelet-rich plasma (PRP). PRP was prepared using 10mL of peripheral blood and the Autologous Conditioned Plasma (ACP; Arhtrex) system. (n=30; 27 assessed) (Mean age: 59.5+/-11.0)
Comparison:
Control group: Patients were not administered postoperative injections. (n=30; 28 assessed) (Mean age: 59.7+/-11.4)
Outcomes:
Magnetic resonance imaging (MRI) was performed to assess tendon integrity and graded using the Sugaya Classification system. Clinical outcome scores included the Quick version of the Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH), the Oxford Shoulder score, the Constant score, visual analog scales for pain frequency and severity, a global rating of change, and patient satisfaction on a scale from 1 to 4.
Methods:
RCT
Time:
Mean follow-up was 42.1+/-4.3 months.

What were the important findings?

  • At the mean follow-up time of 3.5 years, there were no differences in QuickDash, Oxford shoulder score, or the total Constant score between groups (p>0.05). A higher score on the strength subscale of the Constant score was observed in the PRP group (p=0.006).
  • There were no differences in MRI scores or retear rates between groups, with 66.7% of the PRP group and 64.3% of the control patients rated as grade 1 using the Sugaya classification system.

What should I remember most?

In arthroscopic supraspinatus repair, there were no significant differences in clinical or MRI outcomes between patients receiving or not receiving adjunct postoperative platelet-rich plasma injections, with the exception of a possible improvement in abduction strength.

How will this affect the care of my patients?

The use of platelet-rich plasma injections as an adjunct therapy following arthroscopic supraspinatus repair does not appear to provide considerable benefit in either MRI or clinical outcomes for patients at medium-term follow-up.

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Jennifer Fletcher 2018-01-30 10:28 PM

Orthopaedic Surgeon - Canada

Useful study. I don't use PRP.

Anonymous 2018-02-18 9:00 PM

Orthopaedic Surgeon - United States

very useful study.