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Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery?

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Arthrex, Inc.
Information provided by:
The University of Western Australia
ClinicalTrials.gov Identifier:
NCT01414764
First received: June 23, 2011
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Supraspinatus Tear
Other: Autologous conditioned plasma (ACP)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery? A Radomized Control Trial.

Further study details as provided by The University of Western Australia:

Primary Outcome Measures:
  • Changes in magnetic resonance imaging (MRI) score over time [ Time Frame: Pre-operatively, and 12 months post-operatively ] [ Designated as safety issue: No ]
    MRI will assess the dimensions of the supraspinatus tear pre-operatively. MRI will assess the tendon healing of the supraspinatus tendon post-operatively at 12 months


Secondary Outcome Measures:
  • Changes in shoulder range of motion over time [ Time Frame: pre-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively ] [ Designated as safety issue: No ]

    Shoulder range of motion measures will include:

    • internal humeral rotation of the affected arm
    • external humeral rotation of the affected arm
    • forward flexion of the affected arm
    • abduction of the affected arm

  • Changes in strength of the shoulder musculature over time [ Time Frame: 6 months post-operatively, 12 months post-operatively ] [ Designated as safety issue: No ]

    Muscular strength will be measured through:

    • internal humeral rotation of the affected arm
    • external humeral rotation of the affected arm
    • forward flexion of the affected arm
    • abduction of the affected arm

  • Changes in the visual analogue scale (VAS) for pain over time [ Time Frame: 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 ] [ Designated as safety issue: No ]
    The VAS is a scale from 1 to 10 and requires the patient to rate their pain along the scale; with 0 equating to no pain and 10 equating to the worst possible pain.

  • Changes in the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire over time [ Time Frame: Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively ] [ Designated as safety issue: No ]
    The QuickDASH is a shortened version of the Disabilities of the Arm Shoulder and Hand (DASH) outcome measure. It uses 11 items instead of the original 30 items to measure physical function and symptoms in persons with any or multiple musculoskeletal disorders of the upper arm.

  • Changes in the Oxford Shoulder Score (OSS) over time [ Time Frame: Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively ] [ Designated as safety issue: No ]
    The OSS is a self-reported questionnaire developed to evaluate disability in those with injuries and impairment of the rotator cuff.

  • Changes in the Simple Shoulder Test (SST) over time [ Time Frame: Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively ] [ Designated as safety issue: No ]
    The SST consists of a series of 12 "yes" or "no" questions regarding function of the involved shoulder.

  • Changes in the Short Form - 12 health questionnaire (SF-12) over time [ Time Frame: Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively ] [ Designated as safety issue: No ]
    The SF-12 is a shortened version of the Short Form-36 (SF-36). It uses 12 items instead of 36, to measure general functional health and well-being from the patient's point of view.


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Other: 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
Other Name: 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
Drug: 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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414764

Locations
Australia, Western Australia
Fremantle Hospital Radiology Department
Fremantle, Western Australia, Australia, 6160
Sponsors and Collaborators
The University of Western Australia
Arthrex, Inc.
Investigators
Principal Investigator: Allan Wang, FRACS PhD The University of Western Australia
Study Chair: Timothy Ackland, BSc PhD The University of Western Australia
  More Information

Publications:
Responsible Party: Prof. Allan Wang, University of Western Australia
ClinicalTrials.gov Identifier: NCT01414764     History of Changes
Other Study ID Numbers: 11/75
Study First Received: June 23, 2011
Last Updated: August 10, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The University of Western Australia:
rotator cuff tendon repair surgery
supraspinatus tendon repair

Additional relevant MeSH terms:
Anesthetics, Local
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014