Rotator Cuff TearPhase 4NCT03916198
Polydeoxyribonucleotide (PDRN) for Cuff Regeneration
A Phase 4 study testing Polydeoxyribonucleotides and Normal saline in people with Rotator Cuff Tear, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
This study is to evaluate the effect of polydeoxyribonucleotide (PDRN) for healing and fatty degeneration of rotator cuff. The investigators will enroll 130 patients with rotator cuff tear who will undergo arthroscopic rotator cuff repair. 130 patients will be classified into two group. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Polydeoxyribonucleotides and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 May 2019to 22 Feb 2022
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- definite rotator cuff tear on preoperative MRI, which needs repair
- acceptance of arthroscopic surgery including rotator cuff repair
Who cannot join
- history of ipsilateral shoulder operation or fracture
- concomitant neurological disorder around the
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253
About this study
Official title: Effect of Polydeoxyribonucleotide (PDRN) on Healing and Fatty Degeneration of Rotator Cuff in Human
This study is to evaluate the effect of polydeoxyribonucleotide (PDRN) for healing and fatty degeneration of rotator cuff. The investigators will enroll 130 patients with rotator cuff tear who will undergo arthroscopic rotator cuff repair. 130 patients will be classified into two group. One group (PDRN) will be injected at the repaired cuff with 3cc polydeoxyribonucleotide just after surgery and be injected with another 3ml polydeoxyribonucleotide under ultrasound guidance 2 weeks after the surgery. The other group (CONTROL) will be injected with 3ml normal saline in the same manner.
Read the detailed description
Polydeoxyribonucleotide is a tissue regeneration activator. It binds an adenosine receptor and stimulate VEGF(vascular endothelial growth factor) synthesis and stimulate collagen synthesis. Nowadays, a lot of arthroscopic rotator cuff repairs are being performed. but the failure rate of rotator cuff repair is considerably high. Therefore, this study is to evaluate the effect of polydeoxyribonucleotide for healing and fatty degeneration of rotator cuff.
Visual analog scale (VAS) of pain and other functional scores of the two group will be checked preoperatively and postoperative 3, 6, 12, 24 months. Growth factors (VEGF, fibroblast growth factor(FGF), insulin like growth factor(IGF)) will be checked preoperatively and postoperative 1h, 2 days, 2 weeks, 6 weeks, 3, 6 months. Follow up MRI will be checked at postoperative 6 months. The parameters will be compared using statistical analysis.
- Conditions
- Rotator Cuff Tear
- Being tested
- Polydeoxyribonucleotides, Normal saline
- Keywords
- healing, fatty degeneration, retear
- Medical subject headings
- Rotator Cuff Injuries, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolydeoxyribonucleotidesDrug
Also called PDRN
Just after arthroscopic rotator cuff repair, 3cc polydeoxyribonucleotide will be injected, and 2 weeks after the surgery the same amount of the material will be injected.
Normal salineDrug
Just after arthroscopic rotator cuff repair, 3cc normal saline will be injected, and 2 weeks after the surgery the same amount of the material will be injected.
| Study group | Role | What they receive |
|---|---|---|
| PDRN(polydeoxyribonucleotide) | Experimental | polydeoxyribonucleotide 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance Receives: Drug: Polydeoxyribonucleotides |
| CONTROL(normal saline) | Placebo comparator | normal saline 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow score
functional score of shoulder between 0 to 100(0: bad, 100: good)
Measured: 2 years
Secondary outcomes (1)
Constant score
functional score of shoulder between 0 to 100(0: bad, 100: good)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start9 May 2019
- Primary completion9 Aug 2021
- Study completion22 Feb 2022
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 79 participants with rotator cuff tear will be classified into two group. One group (PDRN) will be injected at the repaired cuff with 3cc polydeoxyribonucleotide just after surgery and be injected with another 3cc polydeoxyribonucleotide under ultrasound guidance 2 weeks after the surgery. The other group (CONTROL) will be injected with 3ml normal saline in the same manner.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- Responsible party
- Principal investigator, Jung-Taek Hwang, Chuncheon Sacred Heart Hospital
- Investigators
- Jung-Taek Hwang, MD,PhD, Principal investigator, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916198
- Sponsor's protocol ID
- 2019-01-021
- Status last verified
- Jun 2022
- First submitted
- 10 Apr 2019
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is a privacy problem. The investigators should negotiate with our government about that.
Publications
Altavilla D, Squadrito F, Polito F, Irrera N, Calo M, Lo Cascio P, Galeano M, La Cava L, Minutoli L, Marini H, Bitto A. Activation of adenosine A2A receptors restores the altered cell-cycle machinery during impaired wound healing in genetically diabetic mice. Surgery. 2011 Feb;149(2):253-61. doi: 10.1016/j.surg.2010.04.024. Epub 2010 Jun 8.
PubMed 20570301Galeano M, Bitto A, Altavilla D, Minutoli L, Polito F, Calo M, Lo Cascio P, Stagno d'Alcontres F, Squadrito F. Polydeoxyribonucleotide stimulates angiogenesis and wound healing in the genetically diabetic mouse. Wound Repair Regen. 2008 Mar-Apr;16(2):208-17. doi: 10.1111/j.1524-475X.2008.00361.x.
PubMed 18318806Kang SH, Choi MS, Kim HK, Kim WS, Bae TH, Kim MK, Chang SH. Polydeoxyribonucleotide improves tendon healing following achilles tendon injury in rats. J Orthop Res. 2018 Jun;36(6):1767-1776. doi: 10.1002/jor.23796. Epub 2017 Nov 28.
PubMed 29094396
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Polydeoxyribonucleotide (PDRN) on Healing and Fatty Degeneration of Rotator Cuff in Human
- ClinicalTrials.gov ID
- NCT03916198
- Acronym / sponsor ID
- 2019-01-021
- Conditions
- Rotator Cuff Tear
- Keywords
- healing, fatty degeneration, retear
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- Study start
- 9 May 2019 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 16 Apr 2019 (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.
This study is to evaluate the effect of polydeoxyribonucleotide (PDRN) for healing and fatty degeneration of rotator cuff. The investigators will enroll 130 patients with rotator cuff tear who will undergo arthroscopic rotator cuff repair. 130 patients will be classified into two group. One group (PDRN) will be injected at the repaired cuff with 3cc polydeoxyribonucleotide just after surgery and be injected with another 3ml polydeoxyribonucleotide under ultrasound guidance 2 weeks after the surgery. The other group (CONTROL) will be injected with 3ml normal saline in the same manner.
Detailed description
Polydeoxyribonucleotide is a tissue regeneration activator. It binds an adenosine receptor and stimulate VEGF(vascular endothelial growth factor) synthesis and stimulate collagen synthesis. Nowadays, a lot of arthroscopic rotator cuff repairs are being performed. but the failure rate of rotator cuff repair is considerably high. Therefore, this study is to evaluate the effect of polydeoxyribonucleotide for healing and fatty degeneration of rotator cuff.
Visual analog scale (VAS) of pain and other functional scores of the two group will be checked preoperatively and postoperative 3, 6, 12, 24 months. Growth factors (VEGF, fibroblast growth factor(FGF), insulin like growth factor(IGF)) will be checked preoperatively and postoperative 1h, 2 days, 2 weeks, 6 weeks, 3, 6 months. Follow up MRI will be checked at postoperative 6 months. The parameters will be compared using statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 79 participants with rotator cuff tear will be classified into two group. One group (PDRN) will be injected at the repaired cuff with 3cc polydeoxyribonucleotide just after surgery and be injected with another 3cc polydeoxyribonucleotide under ultrasound guidance 2 weeks after the surgery. The other group (CONTROL) will be injected with 3ml normal saline in the same manner.
| Arm | Type | Receives |
|---|---|---|
| PDRN(polydeoxyribonucleotide) | Experimental | Drug: Polydeoxyribonucleotidespolydeoxyribonucleotide 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance |
| CONTROL(normal saline) | Placebo comparator | Drug: Normal salinenormal saline 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- definite rotator cuff tear on preoperative MRI, which needs repair
- acceptance of arthroscopic surgery including rotator cuff repair
Key exclusion criteria (2 listed)
- history of ipsilateral shoulder operation or fracture
- concomitant neurological disorder around the
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 |
|---|---|---|
| PolydeoxyribonucleotidesAlso: PDRNJust after arthroscopic rotator cuff repair, 3cc polydeoxyribonucleotide will be injected, and 2 weeks after the surgery the same amount of the material will be injected. | Drug | PDRN(polydeoxyribonucleotide) |
| Normal salineJust after arthroscopic rotator cuff repair, 3cc normal saline will be injected, and 2 weeks after the surgery the same amount of the material will be injected. | Drug | CONTROL(normal saline) |
Primary outcome
American Shoulder and Elbow score
Time frame: 2 years
functional score of shoulder between 0 to 100(0: bad, 100: good)
1 secondary outcome
Constant score
Time frame: 2 years
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 24 Jun 2022.
- Background: PubMed 20570301Altavilla D, Squadrito F, Polito F, Irrera N, Calo M, Lo Cascio P, Galeano M, La Cava L, Minutoli L, Marini H, Bitto A. Activation of adenosine A2A receptors restores the altered cell-cycle machinery during impaired wound healing in genetically diabetic mice. Surgery. 2011 Feb;149(2):253-61. doi: 10.1016/j.surg.2010.04.024. Epub 2010 Jun 8.
- Background: PubMed 18318806Galeano M, Bitto A, Altavilla D, Minutoli L, Polito F, Calo M, Lo Cascio P, Stagno d'Alcontres F, Squadrito F. Polydeoxyribonucleotide stimulates angiogenesis and wound healing in the genetically diabetic mouse. Wound Repair Regen. 2008 Mar-Apr;16(2):208-17. doi: 10.1111/j.1524-475X.2008.00361.x.
- Results publication: PubMed 29094396Kang SH, Choi MS, Kim HK, Kim WS, Bae TH, Kim MK, Chang SH. Polydeoxyribonucleotide improves tendon healing following achilles tendon injury in rats. J Orthop Res. 2018 Jun;36(6):1767-1776. doi: 10.1002/jor.23796. Epub 2017 Nov 28.
- Individual participant dataSharing planned: No. There is a privacy problem. The investigators should negotiate with our government about that.
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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.
Jung-Taek Hwang, MD,PhD principal investigator
Chuncheon Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polydeoxyribonucleotides and Normal saline in people with Rotator Cuff Tear, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
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 2 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 24 Jun 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
American Shoulder and Elbow score (time frame: 2 years). 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 NCT03916198, 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 24 Jun 2022.