Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Science and ICT, Republic of Korea | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to analyze the correlation between the synergistic effects of atelocollagen and hyaluronic acid (HA) in enhancing rotator cuff healing postoperatively in patients undergoing rotator cuff repair surgery.The main questions it aims to answer are:
The researchers will compare the use of atelo collagen and HA alone with no treatment to determine their effectiveness in rotator cuff healing.
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atelo collagen + HA Group | Experimental | Patients receive injections of atelo collagen and HA during arthroscopic rotator cuff repair |
|
| HA only Group | Experimental | Patients receive injection of HA during arthroscopic rotator cuff repair |
|
| Atelo collagen only Group | Experimental | Patients receive injection of Atelo collagen during arthroscopic rotator cuff repair |
|
| No injection Group | No Intervention | Patients do not receive any injections during arthroscopic rotator cuff repair. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atelo collagen injection | Procedure | Patients receive atelocollagen injection during arthroscopic rotator cuff repair. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rotator cuff healing status | Assessed by MRI according to Sugaya classification & cuff muscle atrophy ratio | 6 and 24 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Level | Measured by Visual Analog Scale (0-10, higher score indicates worse result) | 3 months, 6 months, 12 months and 2 years after surgery |
| Functional Improvement of the Shoulder | Measured by American Shoulder and Elbow Surgeons Score (0-100, higher score indicates better function) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Dongtan Sacred Heart Hospital | Hwaseong-si | 18450 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24720329 | Background | Weeks KD 3rd, Dines JS, Rodeo SA, Bedi A. The basic science behind biologic augmentation of tendon-bone healing: a scientific review. Instr Course Lect. 2014;63:443-50. | |
| 25911388 | Background | Cunningham G, Ladermann A, Denard PJ, Kherad O, Burkhart SS. Correlation Between American Shoulder and Elbow Surgeons and Single Assessment Numerical Evaluation Score After Rotator Cuff or SLAP Repair. Arthroscopy. 2015 Sep;31(9):1688-92. doi: 10.1016/j.arthro.2015.03.010. Epub 2015 Apr 22. |
Not provided
Not provided
Individual participant data will not be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 1, 2020 | Oct 3, 2025 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hyaluronic acid injection | Procedure | Patients receive hyaluronic acid injection during arthroscopic rotator cuff repair. |
|
| 3 months, 6 months, 12 months, and 2 years after surgery |
| Range of Motion | Measured using goniometer for forward elevation and external rotation | 3 months, 6 months, 12 months, and 2 years after surgery |
| 29996980 | Background | Walsh MR, Nelson BJ, Braman JP, Yonke B, Obermeier M, Raja A, Reams M. Platelet-rich plasma in fibrin matrix to augment rotator cuff repair: a prospective, single-blinded, randomized study with 2-year follow-up. J Shoulder Elbow Surg. 2018 Sep;27(9):1553-1563. doi: 10.1016/j.jse.2018.05.003. Epub 2018 Jul 9. |
| 32128319 | Result | Kim JH, Kim DJ, Lee HJ, Kim BK, Kim YS. Atelocollagen Injection Improves Tendon Integrity in Partial-Thickness Rotator Cuff Tears: A Prospective Comparative Study. Orthop J Sports Med. 2020 Feb 21;8(2):2325967120904012. doi: 10.1177/2325967120904012. eCollection 2020 Feb. |
| 28872895 | Result | Honda H, Gotoh M, Kanazawa T, Ohzono H, Nakamura H, Ohta K, Nakamura KI, Fukuda K, Teramura T, Hashimoto T, Shichijo S, Shiba N. Hyaluronic Acid Accelerates Tendon-to-Bone Healing After Rotator Cuff Repair. Am J Sports Med. 2017 Dec;45(14):3322-3330. doi: 10.1177/0363546517720199. Epub 2017 Sep 5. |
| 28586622 | Result | Suh DS, Lee JK, Yoo JC, Woo SH, Kim GR, Kim JW, Choi NY, Kim Y, Song HS. Atelocollagen Enhances the Healing of Rotator Cuff Tendon in Rabbit Model. Am J Sports Med. 2017 Jul;45(9):2019-2027. doi: 10.1177/0363546517703336. Epub 2017 Jun 6. |
| 31194057 | Result | Li H, Chen Y, Chen S. Enhancement of rotator cuff tendon-bone healing using bone marrow-stimulating technique along with hyaluronic acid. J Orthop Translat. 2019 Jan 28;17:96-102. doi: 10.1016/j.jot.2019.01.001. eCollection 2019 Apr. |