Rotator Cuff TearASPIRENCT01170312
Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation
A study testing Autologous conditioned plasma (ACP) and Normal saline in people with Rotator Cuff Tear, run by McMaster University at 3 sites in Canada.
Trial summary
Rotator cuff tears are a common injury that lead to pain and loss of function for those who suffer from it. Treatment includes the use of arthroscopic surgery to return function to the patient and reduce their pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Autologous conditioned plasma (ACP) and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 3 sitesCanada
- Study dates
- Sep 2010to Aug 2012
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women who are between 18 and 70 years of age.
- Primary, traumatic or degenerative rotator cuff tears measuring 3 cm or less.
- Rotator cuff tears requiring arthroscopic repair within 18 months of initial diagnosis.
- Provision of informed consent.
Who cannot join
- Rotator cuff tears secondary to a fracture.
- Patients with an associated dislocation at the time of randomization.
- Rotator cuff tears that underwent prior surgical repair or revision arthroscopy.
- Non-surgical rotator cuff associated treatment in the 1 month prior to randomization including corticosteroid injection and anti-inflammatory treatment.
- Prior platelet rich plasma injection.
- Pre-existing conditions associated with upper extremity pain, including arthritis, ongoing infection, carpal tunnel syndrome, cervical neuropathy or other nerve pathology, local malignancy, and systemic disorders (e.g., uncontrolled diabetes, hypothyroidism).
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- Patients with gross shoulder instability.
- Patients with an active infection.
- Patients who are pregnant or plan to become pregnant in the next 12 months.
- Patients with a pre-operative platelet count less than 125,000 and a pre-operative hemoglobin of 7.5g/dl or less.
- Likely problems with follow-up (i.e. patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support).
- Patients who do not read and speak English.
- Patients participating in another ongoing trial that would interfere with the assessment of the primary or secondary outcomes.
- Any other reason (in the judgment of the surgeon).
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
McMaster University
Hamilton, Ontario, L8L8E7
Hamilton General Hospital
Hamilton, Ontario
McMaster Hospital
Hamilton, Ontario
About this study
Official title: Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation (A.S.P.I.R.E.): The Use of Platelet Rich Plasma Following Arthroscopic Repair of Rotator Cuff Tears, A Pilot Study
Rotator cuff tears are a common injury that lead to pain and loss of function for those who suffer from it. Treatment includes the use of arthroscopic surgery to return function to the patient and reduce their pain. This study is interested in a technique that has the potential to improve patient outcomes in terms of less pain and better function after their surgery. Autologous Conditioned Plasma (ACP) or Platelet Rich Plasma (PRP) is the intervention of interest, which is simply the patient's own blood that is withdrawn and spun down to obtain a high concentration of cells called platelets. Platelets release growth factors important for healing, as well as fibrin, which acts like a biological glue. The PRP is then re-injected into the shoulder at the time of surgery and again at 4 weeks. It has been shown to accelerate healing in other studies for injuries such as chronic elbow tendinopathy, but there is no randomized controlled trial that evaluates the effect of PRP in rotator cuff tears. It is on this basis that the study is being performed. Participating patients will receive either a PRP injection or a placebo (normal saline) and the effects will be compared at 2 weeks, 4 weeks, and 6 weeks based on a pain score and return to function questionnaires. The primary hypothesis for this study is that ACP compared with placebo is effective in reducing pain at the site of a rotator cuff injury that has undergone arthroscopic repair. It is expected that ACP administered during surgery and 4 weeks post-surgery will reduce 6-week pain scores compared to the placebo group.
- Conditions
- Rotator Cuff Tear
- Being tested
- Autologous conditioned plasma (ACP), Normal saline
- Keywords
- Arthroscopic repair, Rotator cuff, Platelet rich plasma, Randomized, Pilot
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous conditioned plasma (ACP)Biological
Also called Platelet rich plasma
ACP is not a drug as the patient's own blood plasma is re-injected into the surgical site.
Normal salineOther
Normal saline injection
| Study group | Role | What they receive |
|---|---|---|
| Autologous conditioned plasma | Active comparator | Not described Receives: Biological: Autologous conditioned plasma (ACP) |
| Normal saline | Placebo comparator | Not described Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
To investigate the effect of ACP compared to placebo on pain scores in rotator cuff tears undergoing arthroscopic repair at 6 weeks.
Pain severity will be measured using a Visual Analog Scale (VAS). Subjects will be asked to rate their worst pain in their shoulder for the previous 24 hours on a 100 mm vertical scale with "0" indicating no pain at all and "100" indicating the worst pain the subject can imagine.
Measured: 6 weeks
Secondary outcomes (4)
Physical function
As measured by the Western Ontario Rotator Cuff Index (WORC), the Disabilities of the Arm, Shoulder and Hand Score (DASH), and the Constant Score, administered prior to the surgical intervention, and at 2 weeks, 4 weeks and 6 weeks post-surgery.
Measured: Up to and including 6 weeks
Revision surgery
Measured: Up to and including 6 weeks
Health utility
As measured by the EuroQol-5 Dimensions (EQ-5D) administered prior to the surgical intervention, and at 2 weeks, 4 weeks and 6 weeks post-surgery.
Measured: Up to and including 6 weeks
Adverse events
Measured: Up to and including 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Sponsor
- Investigators
- Mohit Bhandari, MD, MSc, PhD, FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170312
- Sponsor's protocol ID
- PRP-123
- Acronym
- ASPIRE
- Status last verified
- Oct 2012
- First submitted
- 22 Jul 2010
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lopez-Vidriero E, Goulding KA, Simon DA, Sanchez M, Johnson DH. The use of platelet-rich plasma in arthroscopy and sports medicine: optimizing the healing environment. Arthroscopy. 2010 Feb;26(2):269-78. doi: 10.1016/j.arthro.2009.11.015.
PubMed 20141991Randelli PS, Arrigoni P, Cabitza P, Volpi P, Maffulli N. Autologous platelet rich plasma for arthroscopic rotator cuff repair. A pilot study. Disabil Rehabil. 2008;30(20-22):1584-9. doi: 10.1080/09638280801906081.
PubMed 18608363de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. Platelet-rich plasma injection for chronic Achilles tendinopathy: a randomized controlled trial. JAMA. 2010 Jan 13;303(2):144-9. doi: 10.1001/jama.2009.1986.
PubMed 20068208
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation (A.S.P.I.R.E.): The Use of Platelet Rich Plasma Following Arthroscopic Repair of Rotator Cuff Tears, A Pilot Study
- ClinicalTrials.gov ID
- NCT01170312
- Acronym / sponsor ID
- ASPIRE / PRP-123
- Conditions
- Rotator Cuff Tear
- Keywords
- Arthroscopic repair, Rotator cuff, Platelet rich plasma, Randomized, Pilot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Jul 2010 (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.
Rotator cuff tears are a common injury that lead to pain and loss of function for those who suffer from it. Treatment includes the use of arthroscopic surgery to return function to the patient and reduce their pain. This study is interested in a technique that has the potential to improve patient outcomes in terms of less pain and better function after their surgery. Autologous Conditioned Plasma (ACP) or Platelet Rich Plasma (PRP) is the intervention of interest, which is simply the patient's own blood that is withdrawn and spun down to obtain a high concentration of cells called platelets. Platelets release growth factors important for healing, as well as fibrin, which acts like a biological glue. The PRP is then re-injected into the shoulder at the time of surgery and again at 4 weeks. It has been shown to accelerate healing in other studies for injuries such as chronic elbow tendinopathy, but there is no randomized controlled trial that evaluates the effect of PRP in rotator cuff tears. It is on this basis that the study is being performed. Participating patients will receive either a PRP injection or a placebo (normal saline) and the effects will be compared at 2 weeks, 4 weeks, and 6 weeks based on a pain score and return to function questionnaires. The primary hypothesis for this study is that ACP compared with placebo is effective in reducing pain at the site of a rotator cuff injury that has undergone arthroscopic repair. It is expected that ACP administered during surgery and 4 weeks post-surgery will reduce 6-week pain scores compared to the placebo 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 | Active comparator | Biological: Autologous conditioned plasma (ACP) |
| Normal saline | Placebo comparator | Other: Normal saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women who are between 18 and 70 years of age.
- Primary, traumatic or degenerative rotator cuff tears measuring 3 cm or less.
- Rotator cuff tears requiring arthroscopic repair within 18 months of initial diagnosis.
- Provision of informed consent.
Key exclusion criteria (14 listed)
- Rotator cuff tears secondary to a fracture.
- Patients with an associated dislocation at the time of randomization.
- Rotator cuff tears that underwent prior surgical repair or revision arthroscopy.
- Non-surgical rotator cuff associated treatment in the 1 month prior to randomization including corticosteroid injection and anti-inflammatory treatment.
- Prior platelet rich plasma injection.
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 plasmaACP is not a drug as the patient's own blood plasma is re-injected into the surgical site. | Biological | Autologous conditioned plasma |
| Normal salineNormal saline injection | Other | Normal saline |
Primary outcome
Pain score
Time frame: 6 weeks
To investigate the effect of ACP compared to placebo on pain scores in rotator cuff tears undergoing arthroscopic repair at 6 weeks. Pain severity will be measured using a Visual Analog Scale (VAS). Subjects will be asked to rate their worst pain in their shoulder for the previous 24 hours on a 100 mm vertical scale with "0" indicating no pain at all and "100" indicating the worst pain the subject can imagine.
4 secondary outcomes
Physical function
Time frame: Up to and including 6 weeks
Revision surgery
Time frame: Up to and including 6 weeks
Health utility
Time frame: Up to and including 6 weeks
Adverse events
Time frame: Up to and including 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
- Background: PubMed 20141991Lopez-Vidriero E, Goulding KA, Simon DA, Sanchez M, Johnson DH. The use of platelet-rich plasma in arthroscopy and sports medicine: optimizing the healing environment. Arthroscopy. 2010 Feb;26(2):269-78. doi: 10.1016/j.arthro.2009.11.015.
- Background: PubMed 18608363Randelli PS, Arrigoni P, Cabitza P, Volpi P, Maffulli N. Autologous platelet rich plasma for arthroscopic rotator cuff repair. A pilot study. Disabil Rehabil. 2008;30(20-22):1584-9. doi: 10.1080/09638280801906081.
- Background: PubMed 20068208de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. Platelet-rich plasma injection for chronic Achilles tendinopathy: a randomized controlled trial. JAMA. 2010 Jan 13;303(2):144-9. doi: 10.1001/jama.2009.1986.
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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.
Mohit Bhandari, MD, MSc, PhD, FRCSC principal investigator
McMaster University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous conditioned plasma (ACP) and Normal saline in people with Rotator Cuff Tear, run by McMaster University at 3 sites in Canada.
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 14 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: finished, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain score (time frame: 6 weeks). 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 NCT01170312, which also lists 3 linked publications.
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 1 Nov 2012.