Rotator Cuff TearsNCT01266226
Effect of ACP on Surgical Repair of Rotator Cuff Tears
A study testing Autologous conditioned plasma in people with Rotator Cuff Tears, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine if autologous plasma (ACP) is beneficial for better and faster healing following an arthroscopic repair of the rotator cuff. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Autologous conditioned plasma
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2010to Feb 2015
- 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
- Arthroscopic rotator cuff reconstructions of degenerative or traumatic full thickness rotator cuff tears (supraspinatus and/or infraspinatus tendon) performed by Dr. Flury and Dr. Schwyzer
- Suture bridge technique
- No pregnancy at the date of the surgery for women of childbearing potential
- Signed consent form
Who cannot join
- Partial reconstruction of the rotator cuff (PASTA)
- Open reconstruction
- Tendon transfer (latissimus dorsi or pectoralis major)
- Revision surgery
- Omarthrosis (Level ≥ 2 Samilson \& Prieto)
- Systemic arthritis
Show all 16Show fewer
- Rheumatoid arthritis
- Diabetes (insulin treated)
- Requiring surgery in reconstruction of the subscapularis tendon
- Progressive fat inclusion (fatty infiltration of the rotator cuff musculature Goutallier level IV
- Acute or chronic infection
- Pathological bone metabolism
- Insufficient perfusion in the affected arm
- Neuromuscular disease in the affected arm
- Non compliance of the patient
- Disorders which handicap or inhibit the patient to follow the orders of the clinical testers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears
The purpose of this study is to determine if autologous plasma (ACP) is beneficial for better and faster healing following an arthroscopic repair of the rotator cuff.
Read the detailed description
The shoulder joint, specially the rotator cuff, is one of the most complicated joints of the human body. If the tendon has to be fixed at the bone during surgery, the weak point in obtaining a successful surgery is the fixation of the tendon at the bone insertion site. Tendon belongs to the bradytrophic tissue conditional on the reduced blood flow, deep mitosis rate and lowered healing potential. We can boost the healing process with a selective use of PRP (platelet rich plasma). In this process, the healing site is delivered with an elevated concentration of thrombocytes and also growth factors which are constituent parts of them.
In this study, we will test the Arthrex® Double Syringe System. With this system it is possible to obtain ACP (Autologous conditioned plasma) in one centrifugation step. The supernatant contains a concentration of thrombocytes which is twice as high as in the native blood. The concentration of the growth factors is 5-25x higher according to this.
We also want to test if one application of ACP is enough to get a short- and long-term benefit in healing following a rotator cuff tear.
- Conditions
- Rotator Cuff Tears
- Being tested
- Autologous conditioned plasma, Control group
- Keywords
- Rotator cuff tears, ACP
- 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 plasmaDevice
Also called ACP Arthrex
4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.
Control groupDevice
Also called ACP Arthrex
4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.
| Study group | Role | What they receive |
|---|---|---|
| ACP treated | Experimental | The patients are going to get an injection of 4mL autologous conditioned plasma under the footprint following an arthroscopic repair of the rotator cuff. Receives: Device: Autologous conditioned plasma |
| Control group | Placebo comparator | The patients are going to get an injection of 4mL saline solution under the footprint following an arthroscopic repair of the rotator cuff. Receives: Device: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Shoulder Score
The Oxford Shoulder Score used after 3 months is the primary parameter. The Score tests the ability to participate in the patients' normal life before they got injured.
Measured: 3mo (6mo/24mo)
Secondary outcomes (9)
VAS Pain
Measured: 10d po
QuickDASH
Measured: 3/6/24mo
EQ-5D
Measured: 3/6/24 mo
ROM
Measured: 3/6/24mo
Measurement of the abduction strength
Measured: 3/6/24 mo
ASES Score
Measured: 3/6/24mo
Constant Murley Score
Measured: 3/6/24 mo
MRI/X-Ray/Ultrasonic Diagnostics
Measured: 6/24 mo
Measurement of the external rotation strenght
Measured: 3/6/24 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2013
- Study completionFeb 2015
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 Rotator Cuff 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Principal investigator, Matthias Flury, Schulthess Klinik
- Investigators
- Matthias Flury, Dr, Principal investigator, Upper Extremities Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266226
- Sponsor's protocol ID
- ACP01
- Other IDs
- KEK-ZH-Nr. 2010-0309/4
- Status last verified
- May 2015
- First submitted
- 22 Dec 2010
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Flury M, Rickenbacher D, Schwyzer HK, Jung C, Schneider MM, Stahnke K, Goldhahn J, Audige L. Does Pure Platelet-Rich Plasma Affect Postoperative Clinical Outcomes After Arthroscopic Rotator Cuff Repair? A Randomized Controlled Trial. Am J Sports Med. 2016 Aug;44(8):2136-46. doi: 10.1177/0363546516645518. Epub 2016 May 16.
PubMed 27184542
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT01266226
- Acronym / sponsor ID
- ACP01
- Conditions
- Rotator Cuff Tears
- Keywords
- Rotator cuff tears, ACP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- Dec 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Dec 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.
The purpose of this study is to determine if autologous plasma (ACP) is beneficial for better and faster healing following an arthroscopic repair of the rotator cuff.
Detailed description
The shoulder joint, specially the rotator cuff, is one of the most complicated joints of the human body. If the tendon has to be fixed at the bone during surgery, the weak point in obtaining a successful surgery is the fixation of the tendon at the bone insertion site. Tendon belongs to the bradytrophic tissue conditional on the reduced blood flow, deep mitosis rate and lowered healing potential. We can boost the healing process with a selective use of PRP (platelet rich plasma). In this process, the healing site is delivered with an elevated concentration of thrombocytes and also growth factors which are constituent parts of them.
In this study, we will test the Arthrex® Double Syringe System. With this system it is possible to obtain ACP (Autologous conditioned plasma) in one centrifugation step. The supernatant contains a concentration of thrombocytes which is twice as high as in the native blood. The concentration of the growth factors is 5-25x higher according to this.
We also want to test if one application of ACP is enough to get a short- and long-term benefit in healing following a rotator cuff tear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACP treated | Experimental | Device: Autologous conditioned plasmaThe patients are going to get an injection of 4mL autologous conditioned plasma under the footprint following an arthroscopic repair of the rotator cuff. |
| Control group | Placebo comparator | Device: Control groupThe patients are going to get an injection of 4mL saline solution under the footprint following an arthroscopic repair of the rotator cuff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Arthroscopic rotator cuff reconstructions of degenerative or traumatic full thickness rotator cuff tears (supraspinatus and/or infraspinatus tendon) performed by Dr. Flury and Dr. Schwyzer
- Suture bridge technique
- No pregnancy at the date of the surgery for women of childbearing potential
- Signed consent form
Key exclusion criteria (16 listed)
- Partial reconstruction of the rotator cuff (PASTA)
- Open reconstruction
- Tendon transfer (latissimus dorsi or pectoralis major)
- Revision surgery
- Omarthrosis (Level ≥ 2 Samilson \& Prieto)
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 plasmaAlso: ACP Arthrex4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff. | Device | ACP treated |
| Control groupAlso: ACP Arthrex4mL saline application under the footprint following an arthroscopic repair of the rotator cuff. | Device | Control group |
Primary outcome
Oxford Shoulder Score
Time frame: 3mo (6mo/24mo)
The Oxford Shoulder Score used after 3 months is the primary parameter. The Score tests the ability to participate in the patients' normal life before they got injured.
9 secondary outcomes
VAS Pain
Time frame: 10d po
QuickDASH
Time frame: 3/6/24mo
EQ-5D
Time frame: 3/6/24 mo
ROM
Time frame: 3/6/24mo
Measurement of the abduction strength
Time frame: 3/6/24 mo
ASES Score
Time frame: 3/6/24mo
Constant Murley Score
Time frame: 3/6/24 mo
MRI/X-Ray/Ultrasonic Diagnostics
Time frame: 6/24 mo
Measurement of the external rotation strenght
Time frame: 3/6/24 mo
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 20 May 2015.
- Derived from this study: PubMed 27184542Flury M, Rickenbacher D, Schwyzer HK, Jung C, Schneider MM, Stahnke K, Goldhahn J, Audige L. Does Pure Platelet-Rich Plasma Affect Postoperative Clinical Outcomes After Arthroscopic Rotator Cuff Repair? A Randomized Controlled Trial. Am J Sports Med. 2016 Aug;44(8):2136-46. doi: 10.1177/0363546516645518. Epub 2016 May 16.
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
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.
Matthias Flury, Dr principal investigator
Upper Extremities Department
1 site 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 in people with Rotator Cuff Tears, run by Schulthess Klinik 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 4 inclusion and 16 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 20 May 2015. 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. 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?
Oxford Shoulder Score (time frame: 3mo (6mo/24mo)). 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 NCT01266226, 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 20 May 2015.