Rotator Cuff TearNCT03577379
Vascular Changes of Rotator Cuff Repair Augmented With a Whole Blood Fibrin Clot
A study testing Whole Blood Fibrin Clot in people with Rotator Cuff Tear, run by Santa Barbara Cottage Hospital at 1 site in United States.
Trial summary
The goal of this study is to assess whether undergoing surgical repair of the rotator cuff with the additional intervention of whole blood fibrin clot will improve rotator cuff vascularization at the bone-tendon interface repair site and patient outcomes compared to those who do not receive the whole blood fibrin clot… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Whole Blood Fibrin Clot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 25 Apr 2022
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Presence of ultrasonographic or magnetic resonance imaging (MRI) documented rotator cuff tear confirmed at surgery to be a medium to large-sized rotator cuff tear (> 1 cm), which requires intervention due to persistent difficulty in elevation of affected shoulder and/or pain; 2) ability to give informed consent for procedure, rehabilitation, and regular clinical and radiologic follow-up for a minimum period of 6 most post-surgery; and have 3) preoperative blood platelet counts >150,000/microliter.
Who cannot join
- 1) they have a type III subscapularis tear and above due to different rehabilitation protocol; 2) massive, partial, or traumatic cuff tears; 3) partial or incomplete repairs; 4) is a chronic smoker or patient with Parkinson's disease; 5) have a condition that may hinder healing or attending follow-up visits (e.g., diabetes, immunocompromised status, chemotherapy treatment, chronic steroid use); and 6) age >70.
Trial locations and contacts
1 site in 1 country.
United States1 site
De La Vina Surgery Center
Santa Barbara, California, 93101
About this study
The goal of this study is to assess whether undergoing surgical repair of the rotator cuff with the additional intervention of whole blood fibrin clot will improve rotator cuff vascularization at the bone-tendon interface repair site and patient outcomes compared to those who do not receive the whole blood fibrin clot intervention.
Read the detailed description
Patient outcomes after rotator cuff repair vary greatly and depend on the size of the tear itself. Researchers have identified a number of devices that can be used to reinforce the surgical repair and enhance the structure and function of both the muscles and tendons (Jo et al., 2011; Randelli, Arrigoni, Ragone, MEng, Aliprandi, Cabitza, 2011; Proctor, 2014). Reinforcement patches have been used to help improve surgical outcomes, including: allograft rotator cuff, human cadaveric skin, pig and bovine skin, equine pericardium, and porcine intestinal submucosa (Randelli, Arrigoni, Ragone, MEng, Aliprandi, Cabitza, 2011). Although synthetic patches have also shown some effectiveness, these patches do not provide biologic augmentation of the tendon repair (Jo et al., 2011).
Additionally, there has been some research examining the effectiveness of using platelet-rich plasma therapy to help repair both rotator cuff tendinopathy and tears. Platelets play an important role in the healing process and it has been theorized that exposing inflamed or healing tissue to higher densities of platelets can contribute to less pain, better range of motion (ROM), and overall healing (Pandey et al., 2016). The consensus on this type of therapy has shown inconclusive results, however. For example, research by Jo et al. (2011) found no significant change in clinical recovery in respect to pain or ROM compared to a control group. Alternatively, Pandey et al. (2016) found significant improvements in both pain and ROM scores as well as decreased re-tear rates in the plasma-rich protein treatment group. These and other similar studies utilized different methodologies for patient populations (tendinopathy versus full tears, etc.), treatment timing, formulation of platelet-rich plasma or whole blood fibrin clot, and time of follow-up. Further research is needed to identify what treatments, if any, in the field of platelet-rich plasma are most beneficial for patients with rotator cuff tears. Recent research has demonstrated that whole blood fibrin clots concentrate 98% of available platelets and release growth factors including vascular endothelial growth factor over two weeks (Siegel, Clevenger, Proctor, Clegg, \& Proctor, 2017). However, clinical evidence indicating the effect of whole blood fibrin clots on the healing of repaired torn rotator cuffs is lacking (Jo et al., 2011). The goal of this study is to assess whether undergoing surgical repair of the rotator cuff with the additional intervention of whole blood fibrin clot will improve rotator cuff vascularization at the bone-tendon interface repair site and patient outcomes compared to those who do not receive the whole blood fibrin clot intervention.
- Conditions
- Rotator Cuff Tear
- Being tested
- Whole Blood Fibrin Clot
- Keywords
- Rotator cuff repair, whole blood fibrin clot
- 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.
Whole Blood Fibrin ClotOther
For all patients assigned to the treatment group, 35mL of whole blood will be obtained during surgery by an anesthesiologist. 5 mL of the blood will be sent for pre-clot formation cell count evaluation for platelets, red blood cells and white blood cells. The remaining 30mL will be placed into a sterile container with a sintered glass cylinder supported by the lid for fibrin clot formation. The clot formation cups will be placed on a rotator at room temperature for 10 minutes at 125rpm. The fibrin clot will be removed and 5mL of the post-clot serum sent for post-clot formation cell count evaluation for platelets, red blood cells, and white blood cells.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in the control arm will receive standard of care for their rotator cuff tear, and will not receive the additional whole blood fibrin clot. |
| Treatment | Experimental | Patients in the control arm will receive standard of care for their rotator cuff tear, in addition to, the whole blood fibrin clot. Receives: Other: Whole Blood Fibrin Clot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascularity Index
Vascularity or the structural outcome will be assessed at 6 weeks postoperatively using the vascularity index scoring system described in Zumstein et al., (2014).
Measured: Assessed 6 weeks postoperatively.
Secondary outcomes (5)
Visual Analog Scale (VAS)
A 10-point pain scale for pain at night, with 0 being no pain and 10 being unbearable.
Measured: Assessed at baseline and at 1 week, 3 weeks, and then at 3 and 6 months.
Western Ontario Rotator Cuff Index
A 21 - item questionnaire that measures quality of life for patients with rotator cuff disease.
Measured: Assessed at baseline, and 3 and 6 months.
Veterans Rand (VR-12)
A generic quality of life measure that consists of 12 items.
Measured: Assessed at baseline, and 3 and 6 months.
American Shoulder and Elbow Surgeons Score (ASES)
A 100-point scale which measures pain (up to 50 points) and function (up to 50 points). A higher score indicates less pain and better function.
Measured: Assessed at baseline and at 3 and 6 month.
Single Assessment Numeric Evaluation Score (SANE)
A single -item questionnaire that asks "What percentage of normal is your shoulder?" A rating scale from 0% to 100% is given with higher being better.
Measured: Assessed at 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Mar 2019
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Barbara Cottage Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Proctor, Santa Barbara Cottage Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577379
- Sponsor's protocol ID
- 17-34
- Status last verified
- May 2022
- First submitted
- 23 Jun 2018
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results on the aggregate of the sample will be published.
Publications
Proctor CS. Long-term successful arthroscopic repair of large and massive rotator cuff tears with a functional and degradable reinforcement device. J Shoulder Elbow Surg. 2014 Oct;23(10):1508-13. doi: 10.1016/j.jse.2014.01.010. Epub 2014 Apr 13.
PubMed 24725892Proctor CS. Rotator cuff repair augmented with endogenous fibrin clot. Arthrosc Tech. 2012 May 18;1(1):e79-82. doi: 10.1016/j.eats.2012.03.002. Print 2012 Sep.
PubMed 23766981
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Changes of Rotator Cuff Repair Augmented With a Whole Blood Fibrin Clot
- ClinicalTrials.gov ID
- NCT03577379
- Acronym / sponsor ID
- 17-34
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator cuff repair, whole blood fibrin clot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Santa Barbara Cottage HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 5 Jul 2018 (actual)
- 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 goal of this study is to assess whether undergoing surgical repair of the rotator cuff with the additional intervention of whole blood fibrin clot will improve rotator cuff vascularization at the bone-tendon interface repair site and patient outcomes compared to those who do not receive the whole blood fibrin clot intervention.
Detailed description
Patient outcomes after rotator cuff repair vary greatly and depend on the size of the tear itself. Researchers have identified a number of devices that can be used to reinforce the surgical repair and enhance the structure and function of both the muscles and tendons (Jo et al., 2011; Randelli, Arrigoni, Ragone, MEng, Aliprandi, Cabitza, 2011; Proctor, 2014). Reinforcement patches have been used to help improve surgical outcomes, including: allograft rotator cuff, human cadaveric skin, pig and bovine skin, equine pericardium, and porcine intestinal submucosa (Randelli, Arrigoni, Ragone, MEng, Aliprandi, Cabitza, 2011). Although synthetic patches have also shown some effectiveness, these patches do not provide biologic augmentation of the tendon repair (Jo et al., 2011).
Additionally, there has been some research examining the effectiveness of using platelet-rich plasma therapy to help repair both rotator cuff tendinopathy and tears. Platelets play an important role in the healing process and it has been theorized that exposing inflamed or healing tissue to higher densities of platelets can contribute to less pain, better range of motion (ROM), and overall healing (Pandey et al., 2016). The consensus on this type of therapy has shown inconclusive results, however. For example, research by Jo et al. (2011) found no significant change in clinical recovery in respect to pain or ROM compared to a control group. Alternatively, Pandey et al. (2016) found significant improvements in both pain and ROM scores as well as decreased re-tear rates in the plasma-rich protein treatment group. These and other similar studies utilized different methodologies for patient populations (tendinopathy versus full tears, etc.), treatment timing, formulation of platelet-rich plasma or whole blood fibrin clot, and time of follow-up. Further research is needed to identify what treatments, if any, in the field of platelet-rich plasma are most beneficial for patients with rotator cuff tears. Recent research has demonstrated that whole blood fibrin clots concentrate 98% of available platelets and release growth factors including vascular endothelial growth factor over two weeks (Siegel, Clevenger, Proctor, Clegg, \& Proctor, 2017). However, clinical evidence indicating the effect of whole blood fibrin clots on the healing of repaired torn rotator cuffs is lacking (Jo et al., 2011). The goal of this study is to assess whether undergoing surgical repair of the rotator cuff with the additional intervention of whole blood fibrin clot will improve rotator cuff vascularization at the bone-tendon interface repair site and patient outcomes compared to those who do not receive the whole blood fibrin clot intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in the control arm will receive standard of care for their rotator cuff tear, and will not receive the additional whole blood fibrin clot. |
| Treatment | Experimental | Other: Whole Blood Fibrin ClotPatients in the control arm will receive standard of care for their rotator cuff tear, in addition to, the whole blood fibrin clot. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Presence of ultrasonographic or magnetic resonance imaging (MRI) documented rotator cuff tear confirmed at surgery to be a medium to large-sized rotator cuff tear (> 1 cm), which requires intervention due to persistent difficulty in elevation of affected shoulder and/or pain; 2) ability to give informed consent for procedure, rehabilitation, and regular clinical and radiologic follow-up for a minimum period of 6 most post-surgery; and have 3) preoperative blood platelet counts >150,000/microliter.
Key exclusion criteria (1 listed)
- 1) they have a type III subscapularis tear and above due to different rehabilitation protocol; 2) massive, partial, or traumatic cuff tears; 3) partial or incomplete repairs; 4) is a chronic smoker or patient with Parkinson's disease; 5) have a condition that may hinder healing or attending follow-up visits (e.g., diabetes, immunocompromised status, chemotherapy treatment, chronic steroid use); and 6) age >70.
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 |
|---|---|---|
| Whole Blood Fibrin ClotFor all patients assigned to the treatment group, 35mL of whole blood will be obtained during surgery by an anesthesiologist. 5 mL of the blood will be sent for pre-clot formation cell count evaluation for platelets, red blood cells and white blood cells. The remaining 30mL will be placed into a sterile container with a sintered glass cylinder supported by the lid for fibrin clot formation. The clot formation cups will be placed on a rotator at room temperature for 10 minutes at 125rpm. The fibrin clot will be removed and 5mL of the post-clot serum sent for post-clot formation cell count evaluation for platelets, red blood cells, and white blood cells. | Other | Treatment |
Primary outcome
Vascularity Index
Time frame: Assessed 6 weeks postoperatively.
Vascularity or the structural outcome will be assessed at 6 weeks postoperatively using the vascularity index scoring system described in Zumstein et al., (2014).
5 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Assessed at baseline and at 1 week, 3 weeks, and then at 3 and 6 months.
Western Ontario Rotator Cuff Index
Time frame: Assessed at baseline, and 3 and 6 months.
Veterans Rand (VR-12)
Time frame: Assessed at baseline, and 3 and 6 months.
American Shoulder and Elbow Surgeons Score (ASES)
Time frame: Assessed at baseline and at 3 and 6 month.
Single Assessment Numeric Evaluation Score (SANE)
Time frame: Assessed at 3 and 6 months.
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 5 May 2022.
- Background: PubMed 24725892Proctor CS. Long-term successful arthroscopic repair of large and massive rotator cuff tears with a functional and degradable reinforcement device. J Shoulder Elbow Surg. 2014 Oct;23(10):1508-13. doi: 10.1016/j.jse.2014.01.010. Epub 2014 Apr 13.
- Results publication: PubMed 23766981Proctor CS. Rotator cuff repair augmented with endogenous fibrin clot. Arthrosc Tech. 2012 May 18;1(1):e79-82. doi: 10.1016/j.eats.2012.03.002. Print 2012 Sep.
- Individual participant dataSharing planned: No. Results on the aggregate of the sample will be published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Blood Fibrin Clot in people with Rotator Cuff Tear, run by Santa Barbara Cottage Hospital at 1 site in United States.
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 1 inclusion and 1 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 5 May 2022. 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 United States. 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?
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?
Vascularity Index (time frame: Assessed 6 weeks postoperatively.). 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 NCT03577379, which also lists 2 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 5 May 2022.