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. 2020 Feb 21;8(2):2325967120904012.
doi: 10.1177/2325967120904012. eCollection 2020 Feb.

Atelocollagen Injection Improves Tendon Integrity in Partial-Thickness Rotator Cuff Tears: A Prospective Comparative Study

Jong-Ho Kim  1 , Dong-Jin Kim  2 , Hyo-Jin Lee  2 , Baek-Kyu Kim  3 , Yang-Soo Kim  2
Affiliations

Atelocollagen Injection Improves Tendon Integrity in Partial-Thickness Rotator Cuff Tears: A Prospective Comparative Study

Jong-Ho Kim et al. Orthop J Sports Med. .

Abstract

Background: Ongoing controversy surrounds the best treatment modality for partial-thickness rotator cuff tears.

Purpose: To investigate the effects of atelocollagen injection in patients with small, symptomatic, intratendinous rotator cuff tears.

Study design: Randomized controlled trial; Level of evidence, 1.

Methods: From January 2014 to December 2017, 94 patients who had small, symptomatic, intratendinous rotator cuff tears were enrolled and randomly allocated to 1 of 3 groups: intratendinous injection with 0.5 mL of type I atelocollagen (group 1, n = 32), intratendinous injection with 1 mL of type I atelocollagen (group 2, n = 30), and no injection of type I atelocollagen (group 3, n = 32). American Shoulder and Elbow Surgeons score, Constant Shoulder Score, visual analog scale pain score, and range of motion were evaluated before injection; at 3, 6, and 12 months after injection; and at final follow-up. Magnetic resonance imaging (MRI) was performed at least 6 months after injection to evaluate rotator cuff integrity.

Results: Demographic data did not differ significantly among the 3 groups before injection (P > .05). The mean follow-up period was 24.7 months. The functional and pain scores in groups 1 and 2 were significantly improved at final follow-up (P < .05). No significant improvement was seen in functional or pain scores at final follow-up in group 3 (P > .05). Groups 1 and 2 had significantly better functional scores compared with group 3 at final follow-up (P < .05). The proportion of patients with a decrease in size of the torn tendon on follow-up MRI at least 6 months after atelocollagen injection was significantly higher in group 1 (28.1%; P = .02) and group 2 (36.7%; P = .003) compared with group 3 (6.3%).

Conclusion: Atelocollagen injection can improve the functional outcome and integrity of the tendon in intratendinous rotator cuff tears.

Keywords: atelocollagen; injection; intratendinous tear; partial-thickness tear; rotator cuff; shoulder.

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Conflict of interest statement

One or more of the authors has declared the following potential conflict of interest or source of funding: Sewon Cellontech Co donated the RegenSeal product used in this study. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.

Figures

Figure 1.
Figure 1.
CONSORT (Consolidated Standards of Reporting Trials) guidelines flowchart.
Figure 2.
Figure 2.
Ultrasonography-guided intratendinous injection. The needle tip is positioned at the intratendinous tear site (solid arrow). The injected atelocollagen spreads into the intratendinous tear gap between the bursal and articular layer of the torn rotator cuff (dotted arrow). ASSP, articular layer of supraspinatus tendon; BSSP, bursal layer of supraspinatus tendon; GT, greater tuberosity.
Figure 3.
Figure 3.
A 66-year-old woman with an intratendinous rotator cuff tear experienced a decreased tear size of the tendon on 9-month follow-up magnetic resonance imaging (MRI) scan after injection of 1 mL of atelocollagen (T2-weighted fat suppression image). (A) MRI before injection. (B) 6-month follow-up MRI after injection.
See this image and copyright information in PMC

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