Supraspinatis Interstitial Partial-thickness TearsPRP RandomizedNCT02672085
In Vivo Clinical and Radiological Effects of Platelet-rich Plasma on Interstitial Supraspinatus Lesion: Randomized Study
A study testing PRP infiltraiton and Needling in people with Supraspinatis Interstitial Partial-thickness Tears and Platelet-rich Plasma (PRP), run by La Tour Hospital at 1 site in Switzerland.
Trial summary
Background and Rationale: Tedious PRP infiltrations are emerging treatments for tendinopathies and tendon tears. It has been showed effective in different parts of the body, but current evidences for rotator cuff PRP infiltration remains poor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supraspinatis Interstitial Partial-thickness Tears, Platelet-rich Plasma (PRP)
- What is being tested?
- PRP infiltraiton and Needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature (Appendix Informed Consent Form),
- Symptomatic interstitial tear of the supraspinatus tendon,
Who cannot join
- Tear of infraspinatus or subscapularis tendons (same shoulder)
- Frozen shoulder (antepulsion deficit > 20%)
- Corticosteroid shoulder infiltration in the 3 months prior the inclusion,
- Patients suffering from symptomatic anaemia, or patients with severe cardiorespiratory insufficiency,
- Known or suspected non-compliance, drug or alcohol abuse,
- Patients incapable of judgement or under tutelage,
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- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons,
Trial locations and contacts
1 site in 1 country.
Schwitzguébel Adrien, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
La Tour Hospital
Meyrin, Canton of Geneva, 1217
Adrien Schwitzguébel, adrien.schwitzguebel@latour.ch
About this study
Background and Rationale:
Tedious PRP infiltrations are emerging treatments for tendinopathies and tendon tears. It has been showed effective in different parts of the body, but current evidences for rotator cuff PRP infiltration remains poor. Some studies that tested infiltrations on transfixing lesions showed no statistically significant effect of PRP on tendon healing. The investigators believe that this might be explained by a "flushing effect" of PRP into subacromial space or glenohumeral joint. Therefore, it was decided to focus this study on interstitial lesions, in which PRP is entrapped into the lesion for a long time.
Read more
Objective:
The purpose of this study is to evaluate whether intra-tear PRP infiltrations promotes tear repair better than needling procedures of torn tendon in participants with supraspinatus interstitial tears.
As secondary objective, we will study symptoms alleviation in same way. Primary outcome: Primary outcome: Supraspinatus tear size change from baseline will be compared between cases receiving two PRP injections and controls receiving torn tendon needling, 6 months after second injection.
Secondary outcomes: Single Assessment Numeric Evaluation score, Constant score, ASES score, Shoulder pain disability index, and Visual analogue scale changes from baseline will be compared between cases receiving two PRP injections and controls receiving torn tendon needling, 0,1,3, and 6 months after second injection.
Study design: This case-control study is randomized 1:1 between PRP (intervention group) and needling (Control group). It is a superiority trial that will include 84 patients suffering from interstitial supraspinatus tears. As adjuvant therapy, patients from each arm will beneficiate from standard physical therapy program. PRP and needling will be repeated 2 times, at one month interval. First injection will occur up to two months after recruitment. Clinical follow-up will occur from second injection to one year after second injection, with clinical parameters evaluation at 0,1,3, and 6 months after second injection, and control MRI 6 months after second injection.
Study Product / Intervention: Supraspinatus tendon needling with intralesional PRP injection. PRP will be extracted with Regenlab® extraction kit. No other medications used.
Control Intervention (if applicable): Supraspinatus tendon needling with intralesional saline water injection.
Number of Participants with Rationale: 84 patients will be needed (37 in each group). A 10% of dropout has been taken in consideration.
Study Duration: 24 months from recruitment of the first patient to the last follow-up visit. Scientific report will be written within the two months following recruitment of the last patient.
Study Schedule: First-Participant-In: 01.6.2015 Last-Participant-Out: 30.6.2017
Read the detailed description
DETAILLED PLANNED STATISTICAL METHODS
Hypothesis
Null hypothesis: In patients with interstitial rotator cuff tear, there is no difference in term of tendon tear size percentage between baseline and 6 months after intervention.
Alternative hypothesis: In patients with interstitial rotator cuff tear, there is a difference in term of tendon of tendon tear size percentage between baseline and 6 months after intervention.
Determination of Sample Size
No previous data allows predicting the standard deviation of supraspinatus tear volume. In order to evaluate the standard deviation of tear size progression in percentage from baseline, investigators aimed to identify patients followed conservatively for interstitial supraspinatus tears, and in which two MRI has been performed at 3 to 9 months of interval. In this way, 25 patients were identified, and their tear sizes were measured. From this sample, an hypothetical standard deviation of 76% of the initial teas size was estimated. The investigators considered that potential PRP effect on tear size is clinically relevant if it allows a healing of 50% of the lesion size. Taking on consideration those points, 76 patients should be included to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) of 80%. The Type I error probability associated with this test of this null hypothesis is 0.05. Taking in consideration 10% of potential dropouts, it was planned to include 84 patients.
Following planned Analyses will be performed by Dr Adrien Schwitzguébel at the end of the study:
- Baseline clinical parameters They will be compared between the two groups with adapted statistic tests (Chi-squared, Wilcoxon, or T test).
- Primary outcome Supraspinatus tear size percentage difference between baseline and 6 months post intervention will be compared between the two groups with Student test.
- Secondary outcome Clinical scores (Constant, ASES, SPADI, SANE, and VAS) differences between baseline and different time points will be compared between the two groups with Student test (or Wilcoxon test in case of non-parametric distribution). Even if those multiple analysis aims to evaluate clinical evolution of the two groups, no corrections will be applied on p values, but rather the aspect of a global tendency will be integrated in the discussion. In order to see whether small tears are more prone to beneficiate from treatment, correlation coefficient will be calculated between tear size percentage difference and initial tear size.
- Handling of missing data and drop-outs In case of missing clinical parameters on interest for primary outcome calculation, patients will be excluded of the study. In case of missing clinical parameters on interest for secondary outcome calculation or baseline clinical parameters, analysis will be performed by removing patients with the missing value from corresponding analysis only.
- Being tested
- PRP infiltraiton, Needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP infiltraitonProcedure or surgery
Two time with 1 month interval, PRP will be extracted from own blood's patients with Regenlab® extraction kit, and injected into supraspinatus interstitial lesion.
NeedlingProcedure or surgery
Two time with 1 month interval, saline water will be injected into supraspinatus interstitial lesion.
| Study group | Role | What they receive |
|---|---|---|
| PRP infiltration | Experimental | Supraspinatus interstitial lesion needling and infiltration with PRP Receives: Procedure: PRP infiltraiton |
| Needling | Active comparator | Supraspinatus interstitial lesion needling and infiltration with NaCl Receives: Procedure: Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion healing
After second PRP injection, tendon healing will be assessed by comparison of baseline MRI and control MRI
Measured: 6 months
Secondary outcomes (14)
Single Assessment Numeric Evaluation (SANE) score
Changes from baseline will be compared between cases receiving two PRP injections and controls receiving tendon needling, 0,1,3, and 6 months after second injection.
Measured: 0,1,3, and 6 months, and last follow-up (12 months or more)
Pain Scores on the Visual Analogue Scale
Changes from baseline will be compared between cases receiving two PRP injections and controls receiving tendon needling, 0,1,3, and 6 months after second injection.
Measured: 0,1,3, 6 months, and last follow-up (12 months or more)
Constant score
Changes from baseline will be compared between cases receiving two PRP injections and controls receiving tendon needling, 0,1,3, and 6 months after second injection.
Measured: 0,1,3, and 6 months
ASES score
Changes from baseline will be compared between cases receiving two PRP injections and controls receiving tendon needling, 0,1,3, and 6 months after second injection.
Measured: 0,1,3, and 6 months
Shoulder Pain Disability Index score
Changes from baseline will be compared between cases receiving two PRP injections and controls receiving tendon needling, 0,1,3, and 6 months after second injection.
Measured: 0,1,3, and 6 months
Correlation between the initial tear size and the percentage of tear size evolution
The tear size change will be evaluated between the 2 MRI, at the baseline and at the 6 months endpoints. This correlation will be separately evaluated in each study arm, and in the whole sample.
Measured: 6 months
Lesion healing between interstitial lesions that englobes or not the bone-tendon interface
Tendon healing will be assessed by comparison of baseline MRI and control MRI
Measured: 6 months
Time limit in months from the first intervention to the last follow-up
Will be measurerd in months
Measured: 12-36 months
Treatements at the end of the 6 months of PRP/Saline follow-up: Occurence of surgery
The occurence of surgery will be reported in both groups: cases receiving two PRP injections and controls
Measured: between 6 months and the last follow-up
Treatements at the end of the 6 months of PRP/Saline follow-up: Occurence of corticoid infiltrations
The number of infiltrations of the subacromial with corticosteroids bursa will be reported in both groups: cases receiving two PRP injections and controls
Measured: between 6 months and the last follow-up
Treatements at the end of the 6 months of PRP/Saline follow-up: Occurence of other infiltrations
The nature number of infiltrations of the subacromial bursa with others substances (i.e. PRP, sclerosing agents, autologous blood, hyaluronic acid, ...) will be reported in both groups: cases receiving two PRP injections and controls
Measured: between 6 months and the last follow-up
Histological changes of tendon samples in case of surgery: tendon cellularity
Cells count will be compared between cases receiving two PRP injections and controls
Measured: between 6 months and the last follow-up
Histological changes of tendon samples in case of surgery: vascularity
Vascularity (CD34+ blood vessels count) will be compared between cases receiving two PRP injections and controls
Measured: between 6 months and the last follow-up
Histological changes of tendon samples in case of surgery: apoptosis
Apoptosis (p53+ cells count) will be compared between cases receiving two PRP injections and controls
Measured: between 6 months and the last follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (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 Supraspinatis Interstitial Partial-thickness TearsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- La Tour Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rive Droite SA
- Responsible party
- Principal investigator, Adrien Schwitzguebel, La Tour Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672085
- Sponsor's protocol ID
- RCPT PRP
- Acronym
- PRP Randomized
- Status last verified
- Aug 2017
- First submitted
- 5 Jun 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Schwitzguebel AJ, Kolo FC, Tirefort J, Kourhani A, Nowak A, Gremeaux V, Saffarini M, Ladermann A. Efficacy of Platelet-Rich Plasma for the Treatment of Interstitial Supraspinatus Tears: A Double-Blinded, Randomized Controlled Trial. Am J Sports Med. 2019 Jul;47(8):1885-1892. doi: 10.1177/0363546519851097. Epub 2019 Jun 4.
PubMed 31161947
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Clinical and Radiological Effects of Platelet-rich Plasma on Interstitial Supraspinatus Lesion: Randomized Study
- ClinicalTrials.gov ID
- NCT02672085
- Acronym / sponsor ID
- PRP Randomized / RCPT PRP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- La Tour HospitalUniversity, hospital or other
- Collaborators
- Rive Droite SA
- Study start
- Jun 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Feb 2016 (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.
Background and Rationale:
Tedious PRP infiltrations are emerging treatments for tendinopathies and tendon tears. It has been showed effective in different parts of the body, but current evidences for rotator cuff PRP infiltration remains poor. Some studies that tested infiltrations on transfixing lesions showed no statistically significant effect of PRP on tendon healing. The investigators believe that this might be explained by a "flushing effect" of PRP into subacromial space or glenohumeral joint. Therefore, it was decided to focus this study on interstitial lesions, in which PRP is entrapped into the lesion for a long time.
Objective:
The purpose of this study is to evaluate whether intra-tear PRP infiltrations promotes tear repair better than needling procedures of torn tendon in participants with supraspinatus interstitial tears.
As secondary objective, we will study symptoms alleviation in same way. Primary outcome: Primary outcome: Supraspinatus tear size change from baseline will be compared between cases receiving two PRP injections and controls receiving torn tendon needling, 6 months after second injection.
Secondary outcomes: Single Assessment Numeric Evaluation score, Constant score, ASES score, Shoulder pain disability index, and Visual analogue scale changes from baseline will be compared between cases receiving two PRP injections and controls receiving torn tendon needling, 0,1,3, and 6 months after second injection.
Study design: This case-control study is randomized 1:1 between PRP (intervention group) and needling (Control group). It is a superiority trial that will include 84 patients suffering from interstitial supraspinatus tears. As adjuvant therapy, patients from each arm will beneficiate from standard physical therapy program. PRP and needling will be repeated 2 times, at one month interval. First injection will occur up to two months after recruitment. Clinical follow-up will occur from second injection to one year after second injection, with clinical parameters evaluation at 0,1,3, and 6 months after second injection, and control MRI 6 months after second injection.
Study Product / Intervention: Supraspinatus tendon needling with intralesional PRP injection. PRP will be extracted with Regenlab® extraction kit. No other medications used.
Control Intervention (if applicable): Supraspinatus tendon needling with intralesional saline water injection.
Number of Participants with Rationale: 84 patients will be needed (37 in each group). A 10% of dropout has been taken in consideration.
Study Duration: 24 months from recruitment of the first patient to the last follow-up visit. Scientific report will be written within the two months following recruitment of the last patient.
Study Schedule: First-Participant-In: 01.6.2015 Last-Participant-Out: 30.6.2017
Detailed description
DETAILLED PLANNED STATISTICAL METHODS
Hypothesis
Null hypothesis: In patients with interstitial rotator cuff tear, there is no difference in term of tendon tear size percentage between baseline and 6 months after intervention.
Alternative hypothesis: In patients with interstitial rotator cuff tear, there is a difference in term of tendon of tendon tear size percentage between baseline and 6 months after intervention.
Determination of Sample Size
No previous data allows predicting the standard deviation of supraspinatus tear volume. In order to evaluate the standard deviation of tear size progression in percentage from baseline, investigators aimed to identify patients followed conservatively for interstitial supraspinatus tears, and in which two MRI has been performed at 3 to 9 months of interval. In this way, 25 patients were identified, and their tear sizes were measured. From this sample, an hypothetical standard deviation of 76% of the initial teas size was estimated. The investigators considered that potential PRP effect on tear size is clinically relevant if it allows a healing of 50% of the lesion size. Taking on consideration those points, 76 patients should be included to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) of 80%. The Type I error probability associated with this test of this null hypothesis is 0.05. Taking in consideration 10% of potential dropouts, it was planned to include 84 patients.
Following planned Analyses will be performed by Dr Adrien Schwitzguébel at the end of the study:
- Baseline clinical parameters They will be compared between the two groups with adapted statistic tests (Chi-squared, Wilcoxon, or T test).
- Primary outcome Supraspinatus tear size percentage difference between baseline and 6 months post intervention will be compared between the two groups with Student test.
- Secondary outcome Clinical scores (Constant, ASES, SPADI, SANE, and VAS) differences between baseline and different time points will be compared between the two groups with Student test (or Wilcoxon test in case of non-parametric distribution). Even if those multiple analysis aims to evaluate clinical evolution of the two groups, no corrections will be applied on p values, but rather the aspect of a global tendency will be integrated in the discussion. In order to see whether small tears are more prone to beneficiate from treatment, correlation coefficient will be calculated between tear size percentage difference and initial tear size.
- Handling of missing data and drop-outs In case of missing clinical parameters on interest for primary outcome calculation, patients will be excluded of the study. In case of missing clinical parameters on interest for secondary outcome calculation or baseline clinical parameters, analysis will be performed by removing patients with the missing value from corresponding analysis only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP infiltration | Experimental | Procedure: PRP infiltraitonSupraspinatus interstitial lesion needling and infiltration with PRP |
| Needling | Active comparator | Procedure: NeedlingSupraspinatus interstitial lesion needling and infiltration with NaCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form),
- Symptomatic interstitial tear of the supraspinatus tendon,
Key exclusion criteria (9 listed)
- Tear of infraspinatus or subscapularis tendons (same shoulder)
- Frozen shoulder (antepulsion deficit > 20%)
- Corticosteroid shoulder infiltration in the 3 months prior the inclusion,
- Patients suffering from symptomatic anaemia, or patients with severe cardiorespiratory insufficiency,
- Known or suspected non-compliance, drug or alcohol abuse,
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 |
|---|---|---|
| PRP infiltraitonTwo time with 1 month interval, PRP will be extracted from own blood's patients with Regenlab® extraction kit, and injected into supraspinatus interstitial lesion. | Procedure or surgery | PRP infiltration |
| NeedlingTwo time with 1 month interval, saline water will be injected into supraspinatus interstitial lesion. | Procedure or surgery | Needling |
Primary outcome
Lesion healing
Time frame: 6 months
After second PRP injection, tendon healing will be assessed by comparison of baseline MRI and control MRI
14 secondary outcomes
Single Assessment Numeric Evaluation (SANE) score
Time frame: 0,1,3, and 6 months, and last follow-up (12 months or more)
Pain Scores on the Visual Analogue Scale
Time frame: 0,1,3, 6 months, and last follow-up (12 months or more)
Constant score
Time frame: 0,1,3, and 6 months
ASES score
Time frame: 0,1,3, and 6 months
Shoulder Pain Disability Index score
Time frame: 0,1,3, and 6 months
Correlation between the initial tear size and the percentage of tear size evolution
Time frame: 6 months
Lesion healing between interstitial lesions that englobes or not the bone-tendon interface
Time frame: 6 months
Time limit in months from the first intervention to the last follow-up
Time frame: 12-36 months
Treatements at the end of the 6 months of PRP/Saline follow-up: Occurence of surgery
Time frame: between 6 months and the last follow-up
Treatements at the end of the 6 months of PRP/Saline follow-up: Occurence of corticoid infiltrations
Time frame: between 6 months and the last follow-up
Treatements at the end of the 6 months of PRP/Saline follow-up: Occurence of other infiltrations
Time frame: between 6 months and the last follow-up
Histological changes of tendon samples in case of surgery: tendon cellularity
Time frame: between 6 months and the last follow-up
Histological changes of tendon samples in case of surgery: vascularity
Time frame: between 6 months and the last follow-up
Histological changes of tendon samples in case of surgery: apoptosis
Time frame: between 6 months and the last follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 31161947Schwitzguebel AJ, Kolo FC, Tirefort J, Kourhani A, Nowak A, Gremeaux V, Saffarini M, Ladermann A. Efficacy of Platelet-Rich Plasma for the Treatment of Interstitial Supraspinatus Tears: A Double-Blinded, Randomized Controlled Trial. Am J Sports Med. 2019 Jul;47(8):1885-1892. doi: 10.1177/0363546519851097. Epub 2019 Jun 4.
- Individual participant dataSharing planned: No
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.
Schwitzguébel Adrien, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP infiltraiton and Needling in people with Supraspinatis Interstitial Partial-thickness Tears and Platelet-rich Plasma (PRP), run by La Tour Hospital at 1 site in Switzerland.
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 2 inclusion and 9 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 22 Aug 2017. 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 Switzerland. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Schwitzguébel Adrien, MD (adrien.schwitzgueel@latour.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion healing (time frame: 6 months). 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 NCT02672085, 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 22 Aug 2017.