Short-term safety and effectiveness of domestic polyether-ether-ketone suture anchors for rotator cuff repair: A multicenter, randomized, single-blind, parallel-controlled noninferiority study_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

LI Yinghao ¹ , XU Yang ¹ , XU Longwei ² , LI Tao ¹ , LI Ran ¹ ,  TANG Xin ¹

1. Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P. R. China;
2. Department of Orthopedics, Lishui People’s Hospital, Lishui Yunnan, 323000, P. R. China;

Corresponding author：

TANG Xin, Email: tangxin9388@163.com

Keywords：

Rotator cuff tear; polyether-ether-ketone suture anchor; safety; effectiveness

DOI：

10.7507/1002-1892.202207131

Video：

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Objective A multicenter, randomized, single-blind, parallel-controlled noninferiority study was used to evaluate the short-term safety and effectiveness of domestic polyether-ether-ketone (PEEK) suture anchor for rotator cuff repair by comparing with the imported PEEK suture anchor commonly used in clinical practice. Methods A total of 59 patients with rotator cuff tears who were admitted between May 2019 and October 2019 were selected as the research objects. Among them, 3 patients were excluded because they did not meet the selection criteria, and 1 patient withdrew from the study because of serious adverse events. A total of 55 patients were included in the study. They were randomly divided into trial group (n=27) and control group (n=28). The trial group used PEEK suture anchors produced from REJOIN Company, and the control group used PEEK suture anchors from American Arthrex Company. Two patients in control group were lost to follow-up. Twenty-seven patients in trial group and 26 patients in control group were included in the final quantitative analysis. There was no significant difference (P>0.05) in gender, age, disease duration, side and sizes of rotator cuff tears, composition ratio of patients with type 2 diabetes, and preoperative American Shoulder and Elbow Surgeons (ASES) score, Constant-Murley score, University of California at Los Angeles (UCLA) score, and visual analogue scale (VAS) score. The patients were followed up regularly after operation. The postoperative follow-up included safety evaluation (complications, anchor position, and anchor bone reaction) and effectiveness evaluation (shoulder joint function and pain scores, rotator cuff integrity based on Sugaya classification criteria). Results The operations in both groups were successfully completed, and there was no complication related to the operation and suture anchor. All incisions healed by first intention. There was no significant difference in follow-up time between trial group [(5.85±0.77) months] and control group [(5.96±0.72) months] (t=0.535, P=0.595). MRI examination indicated that the repaired tendons were fixed and the anchors did not get loose or torn. At 1 day, 3 months, and 6 months after operation, there was no patient with grade 3-4 anchor bone reaction in the two groups, and there was no significant difference in the bone reaction grading between groups (P>0.05). After operation, the VAS scores of the two groups gradually decreased, and the ASES scores, Constant-Murley scores, and UCLA scores gradually increased, and there were significant differences between groups at each time point (P<0.05). There was no significant difference between groups at different time points (P>0.05). There was no significant difference in Sugaya classification of rotator cuff integrity at 1 day, 3 months, and 6 months after operation between groups (P>0.05). Conclusion The short-term safety and effectiveness of domestic PEEK suture anchors in rotator cuff tear repair are not significant different from those of imported PEEK suture anchors commonly used in clinical practice.

Citation： LI Yinghao, XU Yang, XU Longwei, LI Tao, LI Ran, TANG Xin. Short-term safety and effectiveness of domestic polyether-ether-ketone suture anchors for rotator cuff repair: A multicenter, randomized, single-blind, parallel-controlled noninferiority study. Chinese Journal of Reparative and Reconstructive Surgery, 2022, 36(11): 1335-1342. doi: 10.7507/1002-1892.202207131 Copy

1.	Mueller C, Leggit JC. Shoulder pain-Is it from the shoulder, neck, or both? Fed Pract, 2017, 34(11): 36-39.
2.	McNamara WJ, Lam PH, Murrell GA. Augmentation of rotator cuff repair with gelatin-resorcin-formalin glue: a biomechanical study. Shoulder Elbow, 2022, 14(1 Suppl): 71-75.
3.	Quinlan NJ, Frandsen JJ, Smith KM, et al. Conservatively treated symptomatic rotator cuff tendinopathy may progress to a tear. Arthrosc Sports Med Rehabil, 2022, 4(4): e1449-e1455.
4.	Oh JH, Park MS, Rhee SM. Treatment strategy for irreparable rotator cuff tears. Clin Orthop Surg, 2018, 10(2): 119-134.
5.	Di Benedetto ED, Di Benedetto P, Fiocchi A, et al. Partial repair in irreparable rotator cuff tear: our experience in long-term follow-up. Acta Biomed, 2017, 88(4S): 69-74.
6.	Cho CH, Bae KC, Kim DH. Biomaterials used for suture anchors in orthopedic surgery. Clin Orthop Surg, 2021, 13(3): 287-292.
7.	Schanda JE, Obermayer-Pietsch B, Sommer G, et al. Biomechanical properties of a suture anchor system from human allogenic mineralized cortical bone matrix for rotator cuff repair. BMC Musculoskelet Disord, 2022, 23(1): 422. doi: 10.1186/s12891-022-05371-0.
8.	Foong WS, Zeng GJ, Goh GS, et al. Determining the minimal clinically important difference on the Oxford Shoulder Instability Score in patients undergoing arthroscopic Bankart repair for shoulder instability. Orthop J Sports Med, 2022, 10(1): 23259671211060023. doi: 10.1177/23259671211060023.
9.	Simmer Filho J, Kautsky RM. Arthroscopy limits on anterior shoulder instability. Rev Bras Ortop (Sao Paulo), 2021, 57(1): 14-22.
10.	Chung SW, Oh KS, Kang SJ, et al. Clinical outcomes of arthroscopic rotator cuff repair using poly lactic-co-glycolic acid plus β-tricalcium phosphate biocomposite suture anchors. Clin Shoulder Elb, 2018, 21(1): 22-29.
11.	Filardo G, Di Matteo B, Kon E, et al. Platelet-rich plasma in tendon-related disorders: results and indications. Knee Surg Sports Traumatol Arthrosc, 2018, 26(7): 1984-1999.
12.	Visscher LE, Jeffery C, Gilmour T, et al. The history of suture anchors in orthopaedic surgery. Clin Biomech (Bristol, Avon), 2019, 61: 70-78.
13.	Gao P, Wang H, Xu Y, et al. A non-inferiority comparison of Delta Medical’s PEEK Suture Anchor and Smith & Nephew’s PEEK Suture Anchor in arthroscopic rotator cuff repair: a multicenter prospective single-blind randomized controlled clinical trial. Ann Transl Med, 2021, 9(24): 1767. doi: 10.21037/atm-21-6008.
14.	Di Benedetto P, Gorasso G, Beltrame A, et al. Clinical and radiological outcomes with PEEK suture anchors used in rotator cuff repair: our experience confirm that a perianchor fluid signal on RM does not affect clinical outcome at one year of follow up. Acta Biomed, 2020, 91(14-S): e2020019. doi: 10.23750/abm.v91i14-S.10986.
15.	Lee JH, Lee YB. Clinical and radiologic outcomes of combined use of biocomposite and PEEK suture anchors during arthroscopic rotator cuff repair: A prospective observational study. J Clin Med, 2020, 9(8): 2545. doi: 10.3390/jcm9082545.
16.	Miyake S, Tamai M, Takeuchi Y, et al. Alteration of coracoacromial ligament thickness at the acromial undersurface in patients with rotator cuff tears. JSES Int, 2022, 6(3): 468-472.
17.	Li H, Chen Y, Chen S. Postoperative residual pain is associated with a high magnetic resonance imaging (MRI)-based signal intensity of the repaired supraspinatus tendon. Knee Surg Sports Traumatol Arthrosc, 2019, 27(12): 4014-4020.
18.	Bilsel K, Aliyev O, Altintas B, et al. Subacromial spacer implantation during arthroscopic partial repair in patients with massive irreparable rotator cuff tears provides satisfactory clinical and radiographic outcomes: A retrospective comparative study. Arthrosc Sports Med Rehabil, 2022, 4(3): e1051-e1057.
19.	Hijji FY, Cheslik TG, Schneider AD, et al. The popularity of outcome measures used in shoulder arthroplasty literature. Shoulder Elbow, 2021, 13(3): 237-247.
20.	Akhtar M, Nadeem RDA, Shah Gillani SF, et al. Comparison of intra articular NSAID (ketorolac) injection versus hyaluronic acid injection for the mean decrease of pain score (according to UCLA shoulder rating scale) in the management of adhesive capsulitis. Pak J Pharm Sci, 2019, 32(3): 953-956.
21.	Beauchamp JÉ, Beauchamp M. Functional outcomes of arthroscopic transosseous rotator cuff repair using a 2-mm tape suture in a 137-patient cohort. JSES Int, 2021, 5(6): 1105-1110.
22.	Stewart CMB, Raja H, Torrance E, et al. In vivo randomized controlled study of the bone response of all-suture anchors and biocomposite anchors. Orthop J Sports Med, 2020, 8(4): 2325967120914965. doi: 10.1177/2325967120914965.
23.	Christensen J, Fischer B, Nute M, et al. Fixation strength of polyetheretherketone sheath-and-bullet device for soft tissue repair in the foot and ankle. J Foot Ankle Surg, 2018, 57(1): 60-64.
24.	Kim JH, Kim YS, Park I, et al. A comparison of open-construct PEEK suture anchor and non-vented biocomposite suture anchor in arthroscopic rotator cuff repair: A prospective randomized clinical trial. Arthroscopy, 2020, 36(2): 389-396.
25.	Chen S, He Y, Wu D, et al. Postoperative bone marrow edema lasts no more than 6 months after uncomplicated arthroscopic double-row rotator cuff repair with PEEK anchors. Knee Surg Sports Traumatol Arthrosc, 2021, 29(1): 162-169.
26.	Yu H, Feng Z, Wang L, et al. Finite element study of PEEK materials applied in post-retained restorations. Polymers (Basel), 2022, 14(16): 3422. doi: 10.3390/polym14163422.
27.	Khurshid Z, Nedumgottil BM, Ali RMM, et al. Insufficient evidence to ascertain the long-term survival of PEEK dental prostheses: A systematic review of clinical studies. Polymers (Basel), 2022, 14(12): 2441. doi: 10.3390/polym14122441.
28.	Yu D, Lei X, Zhu H. Modification of polyetheretherketone (PEEK) physical features to improve osteointegration. J Zhejiang Univ Sci B, 2022, 23(3): 189-203.
29.	Ro K, Pancholi S, Son HS, et al. Perianchor cyst formation after arthroscopic rotator cuff repair using all-suture-type, bioabsorbable-type, and PEEK-type anchors. Arthroscopy, 2019, 35(8): 2284-2292.

1. Mueller C, Leggit JC. Shoulder pain-Is it from the shoulder, neck, or both? Fed Pract, 2017, 34(11): 36-39.
2. McNamara WJ, Lam PH, Murrell GA. Augmentation of rotator cuff repair with gelatin-resorcin-formalin glue: a biomechanical study. Shoulder Elbow, 2022, 14(1 Suppl): 71-75.
3. Quinlan NJ, Frandsen JJ, Smith KM, et al. Conservatively treated symptomatic rotator cuff tendinopathy may progress to a tear. Arthrosc Sports Med Rehabil, 2022, 4(4): e1449-e1455.
4. Oh JH, Park MS, Rhee SM. Treatment strategy for irreparable rotator cuff tears. Clin Orthop Surg, 2018, 10(2): 119-134.
5. Di Benedetto ED, Di Benedetto P, Fiocchi A, et al. Partial repair in irreparable rotator cuff tear: our experience in long-term follow-up. Acta Biomed, 2017, 88(4S): 69-74.
6. Cho CH, Bae KC, Kim DH. Biomaterials used for suture anchors in orthopedic surgery. Clin Orthop Surg, 2021, 13(3): 287-292.
7. Schanda JE, Obermayer-Pietsch B, Sommer G, et al. Biomechanical properties of a suture anchor system from human allogenic mineralized cortical bone matrix for rotator cuff repair. BMC Musculoskelet Disord, 2022, 23(1): 422. doi: 10.1186/s12891-022-05371-0.
8. Foong WS, Zeng GJ, Goh GS, et al. Determining the minimal clinically important difference on the Oxford Shoulder Instability Score in patients undergoing arthroscopic Bankart repair for shoulder instability. Orthop J Sports Med, 2022, 10(1): 23259671211060023. doi: 10.1177/23259671211060023.
9. Simmer Filho J, Kautsky RM. Arthroscopy limits on anterior shoulder instability. Rev Bras Ortop (Sao Paulo), 2021, 57(1): 14-22.
10. Chung SW, Oh KS, Kang SJ, et al. Clinical outcomes of arthroscopic rotator cuff repair using poly lactic-co-glycolic acid plus β-tricalcium phosphate biocomposite suture anchors. Clin Shoulder Elb, 2018, 21(1): 22-29.
11. Filardo G, Di Matteo B, Kon E, et al. Platelet-rich plasma in tendon-related disorders: results and indications. Knee Surg Sports Traumatol Arthrosc, 2018, 26(7): 1984-1999.
12. Visscher LE, Jeffery C, Gilmour T, et al. The history of suture anchors in orthopaedic surgery. Clin Biomech (Bristol, Avon), 2019, 61: 70-78.
13. Gao P, Wang H, Xu Y, et al. A non-inferiority comparison of Delta Medical’s PEEK Suture Anchor and Smith & Nephew’s PEEK Suture Anchor in arthroscopic rotator cuff repair: a multicenter prospective single-blind randomized controlled clinical trial. Ann Transl Med, 2021, 9(24): 1767. doi: 10.21037/atm-21-6008.
14. Di Benedetto P, Gorasso G, Beltrame A, et al. Clinical and radiological outcomes with PEEK suture anchors used in rotator cuff repair: our experience confirm that a perianchor fluid signal on RM does not affect clinical outcome at one year of follow up. Acta Biomed, 2020, 91(14-S): e2020019. doi: 10.23750/abm.v91i14-S.10986.
15. Lee JH, Lee YB. Clinical and radiologic outcomes of combined use of biocomposite and PEEK suture anchors during arthroscopic rotator cuff repair: A prospective observational study. J Clin Med, 2020, 9(8): 2545. doi: 10.3390/jcm9082545.
16. Miyake S, Tamai M, Takeuchi Y, et al. Alteration of coracoacromial ligament thickness at the acromial undersurface in patients with rotator cuff tears. JSES Int, 2022, 6(3): 468-472.
17. Li H, Chen Y, Chen S. Postoperative residual pain is associated with a high magnetic resonance imaging (MRI)-based signal intensity of the repaired supraspinatus tendon. Knee Surg Sports Traumatol Arthrosc, 2019, 27(12): 4014-4020.
18. Bilsel K, Aliyev O, Altintas B, et al. Subacromial spacer implantation during arthroscopic partial repair in patients with massive irreparable rotator cuff tears provides satisfactory clinical and radiographic outcomes: A retrospective comparative study. Arthrosc Sports Med Rehabil, 2022, 4(3): e1051-e1057.
19. Hijji FY, Cheslik TG, Schneider AD, et al. The popularity of outcome measures used in shoulder arthroplasty literature. Shoulder Elbow, 2021, 13(3): 237-247.
20. Akhtar M, Nadeem RDA, Shah Gillani SF, et al. Comparison of intra articular NSAID (ketorolac) injection versus hyaluronic acid injection for the mean decrease of pain score (according to UCLA shoulder rating scale) in the management of adhesive capsulitis. Pak J Pharm Sci, 2019, 32(3): 953-956.
21. Beauchamp JÉ, Beauchamp M. Functional outcomes of arthroscopic transosseous rotator cuff repair using a 2-mm tape suture in a 137-patient cohort. JSES Int, 2021, 5(6): 1105-1110.
22. Stewart CMB, Raja H, Torrance E, et al. In vivo randomized controlled study of the bone response of all-suture anchors and biocomposite anchors. Orthop J Sports Med, 2020, 8(4): 2325967120914965. doi: 10.1177/2325967120914965.
23. Christensen J, Fischer B, Nute M, et al. Fixation strength of polyetheretherketone sheath-and-bullet device for soft tissue repair in the foot and ankle. J Foot Ankle Surg, 2018, 57(1): 60-64.
24. Kim JH, Kim YS, Park I, et al. A comparison of open-construct PEEK suture anchor and non-vented biocomposite suture anchor in arthroscopic rotator cuff repair: A prospective randomized clinical trial. Arthroscopy, 2020, 36(2): 389-396.
25. Chen S, He Y, Wu D, et al. Postoperative bone marrow edema lasts no more than 6 months after uncomplicated arthroscopic double-row rotator cuff repair with PEEK anchors. Knee Surg Sports Traumatol Arthrosc, 2021, 29(1): 162-169.
26. Yu H, Feng Z, Wang L, et al. Finite element study of PEEK materials applied in post-retained restorations. Polymers (Basel), 2022, 14(16): 3422. doi: 10.3390/polym14163422.
27. Khurshid Z, Nedumgottil BM, Ali RMM, et al. Insufficient evidence to ascertain the long-term survival of PEEK dental prostheses: A systematic review of clinical studies. Polymers (Basel), 2022, 14(12): 2441. doi: 10.3390/polym14122441.
28. Yu D, Lei X, Zhu H. Modification of polyetheretherketone (PEEK) physical features to improve osteointegration. J Zhejiang Univ Sci B, 2022, 23(3): 189-203.
29. Ro K, Pancholi S, Son HS, et al. Perianchor cyst formation after arthroscopic rotator cuff repair using all-suture-type, bioabsorbable-type, and PEEK-type anchors. Arthroscopy, 2019, 35(8): 2284-2292.

Chinese Journal of Reparative and Reconstructive Surgery

Short-term safety and effectiveness of domestic polyether-ether-ketone suture anchors for rotator cuff repair: A multicenter, randomized, single-blind, parallel-controlled noninferiority study

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