Tendon InjuriesPhase 1NCT07456215
The Effect of Platelet Rich Plasma (PRP) Application on Rotator Cuff Tear.
A Phase 1 study testing Platelet Rich Plasma and Normal saline in people with Tendon Injuries and Supraspinatus Injury, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The aim of this randomized control trial is to evaluate the impact and effectiveness of PRP on tenocyte metabolism and tendon tissue properties in rotator cuff tear. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tendon Injuries, Supraspinatus Injury, PRP
- What is being tested?
- Platelet Rich Plasma and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 23 Dec 2022to 14 Jan 2026
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Full thickness rotator cuff tear treated with arthroscopic repair
- Age of 18 to 65 years
- Chronic shoulder pain due to rotator cuff tear
- Magnetic resonance imaging study within 6 months prior to arthroscopy
- Goutallier grade 1 or 2 muscle fatty infiltration
Who cannot join
- Comorbidities, including coagulopathy, liver disease, cancer, nutritional disorder
- Goutallier grade 3 or 4 muscle fatty infiltration
- Shoulder osteoarthritis, rotator cuff arthropathy, rheumatoid arthritis
- History oof shoulder injection within the last 12 months
- History of prior shoulder surgery
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this randomized control trial is to evaluate the impact and effectiveness of PRP on tenocyte metabolism and tendon tissue properties in rotator cuff tear.
Read the detailed description
The refractory to conservative treatment rotator cuff tears are mainly treated with arthroscopic repair. Intraoperative or postoperative platelet rich plasma (PRP) injections have been widely used to enhance the tendon healing and the repair process. Additionally, subacromial PRP injections are related to favorable outcomes in case of partial rotator cuff tears even one month after their application. Laboratory and clinical trials have correlated PRP with an increase in tenocyte metabolic activity, based on the up- or downregulation of specific gene expression.
Patients with rotator cuff tear who will be treated surgically will be included in the current study. After obtaining a signed consent form to participate in this trial, the patients will be randomly divided in two groups; the experimental group, where the PRP intervention will be applied, and the control group, where the patients will receive a placebo injection.
The included patients will undergo an ultrasound-assisted PRP or saline subacromial injection, four to six weeks prior to the scheduled surgery. During the arthroscopic rotator cuff repair procedure, a tendon biopsy will be performed and the sample will be sent for further analysis.
The samples will be sent for histologic analysis and quantification of specific gene expression. The gene analysis will contain the collagen I, collagen III, metalloproteinase 3 and metalloproteinase 13 genes, which are related to tendon repair and remodeling in cases of rupture and/or injury. Furthermore, the two groups will be compared in terms of the MRI imaging findings. After statistical analysis, a conclusion regarding the effect of PRP on the enhancement of biological properties of the ruptured tendon and, consecutively, tendon healing process will be extracted.
- Conditions
- Tendon Injuries, Supraspinatus Injury, PRP
- Being tested
- Platelet Rich Plasma, Normal saline
- Keywords
- Supraspinatus tendon, Biology, Collagen, Metalloproteinase, Tenocyte, PRP, Platelet Rich Plasma, Gene expression, Shoulder injection
- Medical subject headings
- Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
Also called PRP
The injection of PRP in the subacromial space.
Normal salineOther
The injection of normal saline in the subacromial space.
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | The experimental group includes patients to whom the PRP intervention will be applied. Receives: Biological: Platelet Rich Plasma |
| Control group | Placebo comparator | The control group includes patients to whom a normal saline injection will be applied. Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movin score
The Movin score qualifies the characteristics of tendon structure, including : fiber arrangement, fiber structure, rounding of the nuclei, inflammation, angiogenesis and cell density. The scores of the experimental and control groups will be compared.
Measured: Immediately after surgery.
Secondary outcomes (8)
Bonar score
The Bonar score qualifies the characteristics of tendon structure, including : tenocytes, collagen, ground substance and vascularity. The scores of the experimental and control groups will be compared.
Measured: Immediately after surgery.
Collagen I gene expression
Collagen I gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Measured: Immediately after surgery.
Collagen II expression
Collagen II expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Measured: Immediately after surgery.
Collagen III gene expression
Collagen IIII expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Measured: Immediately after surgery.
Metalloproteinase 3 gene expression
Metalloproteinase 3 gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Measured: Immediately after surgery.
Metalloproteinase 13 gene expression
Metalloproteinase 13 gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Measured: Immediately after surgery.
Interleukin 1β gene expression
Interleukin 1β gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Measured: Immediately after surgery.
Interleukin 6 gene expression
Interleukin 6 gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared.
Measured: Immediately after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start23 Dec 2022
- Primary completion13 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Tendon InjuriesStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with rotator cuff tear who will be treated surgically will be included in the current study. After obtaining a signed consent form to participate in this trial, the patients will be randomly divided in two groups; the experimental group, where the PRP intervention will be applied, and the control group, where the patients will receive a placebo injection.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charalampos Pitsilos, MSc, Principal investigator, Aristotle University Of ThessalonikiPericles Papadopoulos, PhD, Study chair, Aristotle University Of ThessalonikiIoannis Gigis, PhD, Study director, Aristotle University Of ThessalonikiByron Chalidis, PhD, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456215
- Sponsor's protocol ID
- PRP: Effect on Tendon Biology
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the collection and statistical analysis of the results of this clinical trial, the data will be published in scientific or medical journals.
Publications
Ahmad Z, Ang S, Rushton N, Harvey A, Akhtar K, Dawson-Bowling S, Noorani A. Platelet-Rich Plasma Augmentation of Arthroscopic Rotator Cuff Repair Lowers Retear Rates and Improves Short-Term Postoperative Functional Outcome Scores: A Systematic Review of Meta-Analyses. Arthrosc Sports Med Rehabil. 2022 Feb 5;4(2):e823-e833. doi: 10.1016/j.asmr.2021.12.012. eCollection 2022 Apr.
PubMed 35494273Barber FA. PRP as an Adjunct to Rotator Cuff Tendon Repair. Sports Med Arthrosc Rev. 2018 Jun;26(2):42-47. doi: 10.1097/JSA.0000000000000193.
PubMed 29722762Chalidis B, Givissis P, Papadopoulos P, Pitsilos C. Molecular and Biologic Effects of Platelet-Rich Plasma (PRP) in Ligament and Tendon Healing and Regeneration: A Systematic Review. Int J Mol Sci. 2023 Feb 1;24(3):2744. doi: 10.3390/ijms24032744.
PubMed 36769065Dhillon MS, Behera P, Patel S, Shetty V. Orthobiologics and platelet rich plasma. Indian J Orthop. 2014 Jan;48(1):1-9. doi: 10.4103/0019-5413.125477.
PubMed 24600055Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.
PubMed 25722595Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol. 2009 Mar;27(3):158-67. doi: 10.1016/j.tibtech.2008.11.009. Epub 2009 Jan 31.
PubMed 19187989Giovannetti de Sanctis E, Franceschetti E, De Dona F, Palumbo A, Paciotti M, Franceschi F. The Efficacy of Injections for Partial Rotator Cuff Tears: A Systematic Review. J Clin Med. 2020 Dec 25;10(1):51. doi: 10.3390/jcm10010051.
PubMed 33375716Ho VP, Schiltz NK, Reimer AP, Madigan EA, Koroukian SM. High-Risk Comorbidity Combinations in Older Patients Undergoing Emergency General Surgery. J Am Geriatr Soc. 2019 Mar;67(3):503-510. doi: 10.1111/jgs.15682. Epub 2018 Dec 2.
PubMed 30506953Hopewell S, Boutron I, Chan AW, Collins GS, de Beyer JA, Hrobjartsson A, Nejstgaard CH, Ostengaard L, Schulz KF, Tunn R, Moher D. An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials. Nat Med. 2022 Sep;28(9):1740-1743. doi: 10.1038/s41591-022-01989-8. No abstract available.
PubMed 36109642Jeno SH, Munjal A, Schindler GS. Anatomy, Shoulder and Upper Limb, Arm Supraspinatus Muscle. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537202/
PubMed 30725887Kobayashi Y, Saita Y, Takaku T, Yokomizo T, Nishio H, Ikeda H, Takazawa Y, Nagao M, Kaneko K, Komatsu N. Platelet-rich plasma (PRP) accelerates murine patellar tendon healing through enhancement of angiogenesis and collagen synthesis. J Exp Orthop. 2020 Jul 8;7(1):49. doi: 10.1186/s40634-020-00267-1.
PubMed 32642866Kovacevic D, Suriani RJ Jr, Levine WN, Thomopoulos S. Augmentation of Rotator Cuff Healing With Orthobiologics. J Am Acad Orthop Surg. 2022 Mar 1;30(5):e508-e516. doi: 10.5435/JAAOS-D-20-01011.
PubMed 34932515Ladermann A, Burkhart SS, Hoffmeyer P, Neyton L, Collin P, Yates E, Denard PJ. Classification of full-thickness rotator cuff lesions: a review. EFORT Open Rev. 2017 Mar 13;1(12):420-430. doi: 10.1302/2058-5241.1.160005. eCollection 2016 Dec.
PubMed 28461921Ladermann A, Meynard T, Denard PJ, Ibrahim M, Saffarini M, Collin P. Reliable diagnosis of posterosuperior rotator cuff tears requires a combination of clinical tests. Knee Surg Sports Traumatol Arthrosc. 2021 Jul;29(7):2118-2133. doi: 10.1007/s00167-020-06136-9. Epub 2020 Jul 28.
PubMed 32725446Li S, Wu Y, Jiang G, Tian X, Hong J, Chen S, Yan R, Feng G, Cheng Z. Intratendon delivery of leukocyte-rich platelet-rich plasma at early stage promotes tendon repair in a rabbit Achilles tendinopathy model. J Tissue Eng Regen Med. 2020 Mar;14(3):452-463. doi: 10.1002/term.3006. Epub 2019 Dec 23.
PubMed 31840415
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet Rich Plasma (PRP) Application on Rotator Cuff Tear.
- ClinicalTrials.gov ID
- NCT07456215
- Acronym / sponsor ID
- PRP: Effect on Tendon Biology
- Conditions
- Tendon Injuries, Supraspinatus Injury, PRP
- Keywords
- Supraspinatus tendon, Biology, Collagen, Metalloproteinase, Tenocyte, PRP, Platelet Rich Plasma, Gene expression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 6 Mar 2026 (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 aim of this randomized control trial is to evaluate the impact and effectiveness of PRP on tenocyte metabolism and tendon tissue properties in rotator cuff tear.
Detailed description
The refractory to conservative treatment rotator cuff tears are mainly treated with arthroscopic repair. Intraoperative or postoperative platelet rich plasma (PRP) injections have been widely used to enhance the tendon healing and the repair process. Additionally, subacromial PRP injections are related to favorable outcomes in case of partial rotator cuff tears even one month after their application. Laboratory and clinical trials have correlated PRP with an increase in tenocyte metabolic activity, based on the up- or downregulation of specific gene expression.
Patients with rotator cuff tear who will be treated surgically will be included in the current study. After obtaining a signed consent form to participate in this trial, the patients will be randomly divided in two groups; the experimental group, where the PRP intervention will be applied, and the control group, where the patients will receive a placebo injection.
The included patients will undergo an ultrasound-assisted PRP or saline subacromial injection, four to six weeks prior to the scheduled surgery. During the arthroscopic rotator cuff repair procedure, a tendon biopsy will be performed and the sample will be sent for further analysis.
The samples will be sent for histologic analysis and quantification of specific gene expression. The gene analysis will contain the collagen I, collagen III, metalloproteinase 3 and metalloproteinase 13 genes, which are related to tendon repair and remodeling in cases of rupture and/or injury. Furthermore, the two groups will be compared in terms of the MRI imaging findings. After statistical analysis, a conclusion regarding the effect of PRP on the enhancement of biological properties of the ruptured tendon and, consecutively, tendon healing process will be extracted.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with rotator cuff tear who will be treated surgically will be included in the current study. After obtaining a signed consent form to participate in this trial, the patients will be randomly divided in two groups; the experimental group, where the PRP intervention will be applied, and the control group, where the patients will receive a placebo injection.
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Biological: Platelet Rich PlasmaThe experimental group includes patients to whom the PRP intervention will be applied. |
| Control group | Placebo comparator | Other: Normal salineThe control group includes patients to whom a normal saline injection will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Full thickness rotator cuff tear treated with arthroscopic repair
- Age of 18 to 65 years
- Chronic shoulder pain due to rotator cuff tear
- Magnetic resonance imaging study within 6 months prior to arthroscopy
- Goutallier grade 1 or 2 muscle fatty infiltration
Key exclusion criteria (5 listed)
- Comorbidities, including coagulopathy, liver disease, cancer, nutritional disorder
- Goutallier grade 3 or 4 muscle fatty infiltration
- Shoulder osteoarthritis, rotator cuff arthropathy, rheumatoid arthritis
- History oof shoulder injection within the last 12 months
- History of prior shoulder surgery
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 |
|---|---|---|
| Platelet Rich PlasmaAlso: PRPThe injection of PRP in the subacromial space. | Biological | PRP group |
| Normal salineThe injection of normal saline in the subacromial space. | Other | Control group |
Primary outcome
Movin score
Time frame: Immediately after surgery.
The Movin score qualifies the characteristics of tendon structure, including : fiber arrangement, fiber structure, rounding of the nuclei, inflammation, angiogenesis and cell density. The scores of the experimental and control groups will be compared.
8 secondary outcomes
Bonar score
Time frame: Immediately after surgery.
Collagen I gene expression
Time frame: Immediately after surgery.
Collagen II expression
Time frame: Immediately after surgery.
Collagen III gene expression
Time frame: Immediately after surgery.
Metalloproteinase 3 gene expression
Time frame: Immediately after surgery.
Metalloproteinase 13 gene expression
Time frame: Immediately after surgery.
Interleukin 1β gene expression
Time frame: Immediately after surgery.
Interleukin 6 gene expression
Time frame: Immediately after surgery.
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 6 Mar 2026.
- Background: PubMed 35494273Ahmad Z, Ang S, Rushton N, Harvey A, Akhtar K, Dawson-Bowling S, Noorani A. Platelet-Rich Plasma Augmentation of Arthroscopic Rotator Cuff Repair Lowers Retear Rates and Improves Short-Term Postoperative Functional Outcome Scores: A Systematic Review of Meta-Analyses. Arthrosc Sports Med Rehabil. 2022 Feb 5;4(2):e823-e833. doi: 10.1016/j.asmr.2021.12.012. eCollection 2022 Apr.
- Background: PubMed 29722762Barber FA. PRP as an Adjunct to Rotator Cuff Tendon Repair. Sports Med Arthrosc Rev. 2018 Jun;26(2):42-47. doi: 10.1097/JSA.0000000000000193.
- Background: PubMed 36769065Chalidis B, Givissis P, Papadopoulos P, Pitsilos C. Molecular and Biologic Effects of Platelet-Rich Plasma (PRP) in Ligament and Tendon Healing and Regeneration: A Systematic Review. Int J Mol Sci. 2023 Feb 1;24(3):2744. doi: 10.3390/ijms24032744.
- Background: PubMed 24600055Dhillon MS, Behera P, Patel S, Shetty V. Orthobiologics and platelet rich plasma. Indian J Orthop. 2014 Jan;48(1):1-9. doi: 10.4103/0019-5413.125477.
- Background: PubMed 25722595Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.
- Background: PubMed 19187989Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol. 2009 Mar;27(3):158-67. doi: 10.1016/j.tibtech.2008.11.009. Epub 2009 Jan 31.
- Background: PubMed 33375716Giovannetti de Sanctis E, Franceschetti E, De Dona F, Palumbo A, Paciotti M, Franceschi F. The Efficacy of Injections for Partial Rotator Cuff Tears: A Systematic Review. J Clin Med. 2020 Dec 25;10(1):51. doi: 10.3390/jcm10010051.
- Background: PubMed 30506953Ho VP, Schiltz NK, Reimer AP, Madigan EA, Koroukian SM. High-Risk Comorbidity Combinations in Older Patients Undergoing Emergency General Surgery. J Am Geriatr Soc. 2019 Mar;67(3):503-510. doi: 10.1111/jgs.15682. Epub 2018 Dec 2.
- Background: PubMed 36109642Hopewell S, Boutron I, Chan AW, Collins GS, de Beyer JA, Hrobjartsson A, Nejstgaard CH, Ostengaard L, Schulz KF, Tunn R, Moher D. An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials. Nat Med. 2022 Sep;28(9):1740-1743. doi: 10.1038/s41591-022-01989-8. No abstract available.
- Background: PubMed 30725887Jeno SH, Munjal A, Schindler GS. Anatomy, Shoulder and Upper Limb, Arm Supraspinatus Muscle. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537202/
- Background: PubMed 32642866Kobayashi Y, Saita Y, Takaku T, Yokomizo T, Nishio H, Ikeda H, Takazawa Y, Nagao M, Kaneko K, Komatsu N. Platelet-rich plasma (PRP) accelerates murine patellar tendon healing through enhancement of angiogenesis and collagen synthesis. J Exp Orthop. 2020 Jul 8;7(1):49. doi: 10.1186/s40634-020-00267-1.
- Background: PubMed 34932515Kovacevic D, Suriani RJ Jr, Levine WN, Thomopoulos S. Augmentation of Rotator Cuff Healing With Orthobiologics. J Am Acad Orthop Surg. 2022 Mar 1;30(5):e508-e516. doi: 10.5435/JAAOS-D-20-01011.
- Individual participant dataSharing planned: Yes. After the collection and statistical analysis of the results of this clinical trial, the data will be published in scientific or medical journals.
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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.
Charalampos Pitsilos, MSc principal investigator
Aristotle University Of Thessaloniki
Pericles Papadopoulos, PhD study chair
Aristotle University Of Thessaloniki
Ioannis Gigis, PhD study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Platelet Rich Plasma and Normal saline in people with Tendon Injuries and Supraspinatus Injury, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 5 inclusion and 5 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 6 Mar 2026. 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 Greece. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Movin score (time frame: Immediately after surgery.). 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 NCT07456215, which also lists 28 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 6 Mar 2026.