Supraspinatus TearPhase 3NCT01414764
Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery?
A Phase 3 study testing Autologous conditioned plasma (ACP) in people with Supraspinatus Tear, run by The University of Western Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Supraspinatus Tear
- What is being tested?
- Autologous conditioned plasma (ACP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- May 2011to Feb 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50-75 years;
- In a non-dependent relationship;
- Full-thickness supraspinatus tendon tear (deemed repairable);
- Pre-operative platelet count greater than 150 000.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Fremantle Hospital Radiology Department
Fremantle, Western Australia, 6160
About this study
Official title: Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery? A Radomized Control Trial.
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.
- Conditions
- Supraspinatus Tear
- Being tested
- Autologous conditioned plasma (ACP), Placebo
- Keywords
- rotator cuff tendon repair surgery, supraspinatus tendon repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous conditioned plasma (ACP)Other
Also called Platelet rich plasma (PRP)
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Autologous conditioned plasma (ACP) | Active comparator | 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) Receives: Other: Autologous conditioned plasma (ACP) |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in magnetic resonance imaging (MRI) score over time
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
Measured: Pre-operatively, and 12 months post-operatively
Secondary outcomes (7)
Changes in shoulder range of motion over time
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
Measured: pre-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively
Changes in strength of the shoulder musculature over time
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
Measured: 6 months post-operatively, 12 months post-operatively
Changes in the visual analogue scale (VAS) for pain over time
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.
Measured: 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
Changes in the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire over time
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.
Measured: Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
Changes in the Oxford Shoulder Score (OSS) over time
The OSS is a self-reported questionnaire developed to evaluate disability in those with injuries and impairment of the rotator cuff.
Measured: Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
Changes in the Simple Shoulder Test (SST) over time
The SST consists of a series of 12 "yes" or "no" questions regarding function of the involved shoulder.
Measured: Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
Changes in the Short Form - 12 health questionnaire (SF-12) over time
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.
Measured: Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supraspinatus TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Principal investigator, Allan Wang, The University of Western Australia
- Investigators
- Allan Wang, FRACS PhD, Principal investigator, The University of Western AustraliaTimothy Ackland, BSc PhD, Study chair, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414764
- Sponsor's protocol ID
- 11/75
- Status last verified
- Dec 2014
- First submitted
- 23 Jun 2011
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21570659
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery? A Radomized Control Trial.
- ClinicalTrials.gov ID
- NCT01414764
- Acronym / sponsor ID
- 11/75
- Conditions
- Supraspinatus Tear
- Keywords
- rotator cuff tendon repair surgery, supraspinatus tendon repair
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- May 2011
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous conditioned plasma (ACP) | Active comparator | Other: 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 | Placebo comparator | Drug: Placebo10ml 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 |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 50-75 years;
- In a non-dependent relationship;
- Full-thickness supraspinatus tendon tear (deemed repairable);
- Pre-operative platelet count greater than 150 000.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous conditioned plasma (ACP)Also: Platelet rich plasma (PRP)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 | Autologous conditioned plasma (ACP) |
| Placebo10ml 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 | Drug | Placebo |
Primary outcome
Changes in magnetic resonance imaging (MRI) score over time
Time frame: Pre-operatively, and 12 months post-operatively
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
7 secondary outcomes
Changes in shoulder range of motion over time
Time frame: pre-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively
Changes in strength of the shoulder musculature over time
Time frame: 6 months post-operatively, 12 months post-operatively
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- Results publication: PubMed 21570659Randelli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Wang, FRACS PhD principal investigator
The University of Western Australia
Timothy Ackland, BSc PhD study chair
The University of Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous conditioned plasma (ACP) in people with Supraspinatus Tear, run by The University of Western Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in magnetic resonance imaging (MRI) score over time (time frame: Pre-operatively, and 12 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01414764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.