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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01414764




Registration number
NCT01414764
Ethics application status
Date submitted
23/06/2011
Date registered
11/08/2011
Date last updated
9/12/2014

Titles & IDs
Public title
Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery?
Scientific title
Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery? A Radomized Control Trial.
Secondary ID [1] 0 0
11/75
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Supraspinatus Tear 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Autologous conditioned plasma (ACP)
Treatment: Drugs - Placebo

Active comparator: Autologous conditioned plasma (ACP) - 10ml of patient's own venous blood is aspirated. The syringe is centrifuged in a proprietary closed unit (Arthrex Medical Company) for 5 minutes. The red blood cells will be discarded, and the supernatant containing ACP (with additional CaCl to activate the ACP and local anaesthetic) is injected into the tendon bone junction and adjacent area under ultrasound guidance. No adverse consequences are anticipated by using the Arthrex ACP injection.

* First injection at approximately 10 days post-operatively
* Second Injection at approximately 21 days post-operatively

Other Names:

Platelet rich plasma (PRP)

Placebo comparator: Placebo - 10ml of patient's own venous blood is aspirated. The syringe is centrifuged in a proprietary closed unit (Arthrex Medical Company) for 5 minutes. The venous blood sample will be discarded and a placebo (saline + local anaesthetic) is injected to the surrounding tissue, but not into the tendon, under guided ultrasound.

* First injection at approximately 10 days post-operatively
* Second Injection at approximately 21 days post-operatively


Other interventions: Autologous conditioned plasma (ACP)
10ml of patient's own venous blood is aspirated. ACP (1ml) (extracted from centrifuged venous sample), with additional calcium chloride is then injected into the tendon-bone junction and adjacent area under guided ultrasound.

* First injection at approximately 10 days post-operatively
* Second Injection at approximately 21 days post-operatively

Treatment: Drugs: Placebo
10ml of patient's own venous blood is aspirated. The syringe is centrifuged in a proprietary closed unit (Arthrex Medical Company) for 5 minutes. The venous blood sample will be discarded and a placebo (1ml saline + local anaesthetic) is injected to the surrounding tissue, but not into the tendon, under guided ultrasound.

* First injection at approximately 10 days post-operatively
* Second Injection at approximately 21 days post-operatively
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in magnetic resonance imaging (MRI) score over time
Timepoint [1] 0 0
Pre-operatively, and 12 months post-operatively
Secondary outcome [1] 0 0
Changes in shoulder range of motion over time
Timepoint [1] 0 0
pre-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively
Secondary outcome [2] 0 0
Changes in strength of the shoulder musculature over time
Timepoint [2] 0 0
6 months post-operatively, 12 months post-operatively
Secondary outcome [3] 0 0
Changes in the visual analogue scale (VAS) for pain over time
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Changes in the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire over time
Timepoint [4] 0 0
Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
Secondary outcome [5] 0 0
Changes in the Oxford Shoulder Score (OSS) over time
Timepoint [5] 0 0
Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
Secondary outcome [6] 0 0
Changes in the Simple Shoulder Test (SST) over time
Timepoint [6] 0 0
Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
Secondary outcome [7] 0 0
Changes in the Short Form - 12 health questionnaire (SF-12) over time
Timepoint [7] 0 0
Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2015
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Fremantle Hospital Radiology Department - Fremantle
Recruitment postcode(s) [1] 0 0
6160 - Fremantle

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Arthrex, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01414764
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Allan Wang, FRACS PhD
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01414764