Clinical trial NCT01414764: Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery?
Official title: Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery? A Radomized Control Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Supraspinatus Tear
Keywords: rotator cuff tendon repair surgery
supraspinatus tendon repair
Lead sponsor: The University of Western Australia
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2011-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to establish if the application of autologous conditioned plasma (ACP), also described as platelet rich plasma (PRP), to the site of supraspinatus tendon repair beginning within two weeks of surgery, can improve patient outcomes over the course of 12 months. These outcomes will be measured by post-surgical pain and function scores, shoulder strength and range of motion (ROM), and radiological parameters of tendon healing. Outcome measures will be compared to a control group of patients receiving placebo injections following surgery (saline plus local anaesthetic).

This study is significant for being the first double blind randomised control trial, using two PRP injections to examine the efficacy of a PRP preparation following surgical repair of supraspinatus tendon. The objective is to prolong and enhance the tendon healing response initiated by surgery.

The research hypothesis is that enhanced tendon healing following the PRP injections will lead to more rapid rehabilitation and lower rates of re-rupture of the repaired tendon compared to the control group.


Eligibility criteria: Inclusion Criteria:

* Aged 50-75 years;
* In a non-dependent relationship;
* Full-thickness supraspinatus tendon tear (deemed repairable);
* Pre-operative platelet count greater than 150 000.

Exclusion Criteria:

* Previous rotator cuff repair surgery;
* Active/distal infection;
* Metabolic bone or blood disorders;
* Pre-existing conditions associated with upper extremity pain;
* Rotator cuff tears secondary to fracture;
* Prior ACP/PRP injections;
* Non-surgical rotator cuff treatment in the past month, including corticosteroids and anti-inflammatory treatment.

Primary outcomes:
measure: Changes in magnetic resonance imaging (MRI) score over time
timeFrame: Pre-operatively, and 12 months post-operatively
Secondary outcomes:
measure: Changes in shoulder range of motion over time
timeFrame: pre-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively
measure: Changes in strength of the shoulder musculature over time
timeFrame: 6 months post-operatively, 12 months post-operatively
measure: Changes in the visual analogue scale (VAS) for pain over time
timeFrame: Pre-operatively, 1st injection post-operatively, 2nd injection post-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
measure: Changes in the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire over time
timeFrame: Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
measure: Changes in the Oxford Shoulder Score (OSS) over time
timeFrame: Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
measure: Changes in the Simple Shoulder Test (SST) over time
timeFrame: Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
measure: Changes in the Short Form - 12 health questionnaire (SF-12) over time
timeFrame: Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
Other outcomes:
Locations:
city: Fremantle
country: Australia
facility: Fremantle Hospital Radiology Department
state: Western Australia
Study officials:
affiliation: The University of Western Australia
name: Allan Wang, FRACS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Western Australia
name: Timothy Ackland, BSc PhD
role: STUDY_CHAIR
References:
citation: Randelli P, Arrigoni P, Ragone V, Aliprandi A, Cabitza P. Platelet rich plasma in arthroscopic rotator cuff repair: a prospective RCT study, 2-year follow-up. J Shoulder Elbow Surg. 2011 Jun;20(4):518-28. doi: 10.1016/j.jse.2011.02.008.