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
机构:[1]Hunan Normal Univ, Affiliated Hosp 1, Hunan Prov Peoples Hosp, Dept Joint Surg & Sports Med, Changsha, Peoples R China[2]Inner Mongolia Autonomous Reg Peoples Hosp, Dept Bone & Joint Surg, Hohhot, Peoples R China[3]Kunming Med Univ, Dept Sport Med, Affiliated Hosp 1, Kunming, Yunnan, Peoples R China外科科室运动医学科昆明医科大学附属第一医院[4]Tradit Chinese Med Hosp Zhongshan, Dept Orthoped, Zhongshan, Peoples R China[5]Hunan Univ Med, Affiliated Hosp Tradit Chinese Med, Tradit Chinese Med Hosp, Dept Orthoped, Huaihua, Peoples R China
Background: To compare the early clinical outcomes and Magnetic Resonance Imaging (MRI) results of Delta Medical's PEEK (polyether ether ketone) suture anchor with those of Smith & Nephew's PEEK suture anchor in patients with arthroscopic rotator cuff repair. Methods: A total of 106 patients in four different medical centers were randomly allocated into two groups: Delta Medical's PEEK suture anchor (53 patients); Smith & Nephew's PEEK suture anchor (53 patients). The MRI results and early clinical outcomes were evaluated at 3 and 6 months postoperatively. The University of California at Los Angeles (UCLA) shoulder rating scale and the visual analog scale (VAS) score for pain and range of motion were evaluated. MRI were performed at 3 and 6 months postoperatively to examine the integrity of the repaired rotator cuff tendon based on the Sugaya classification. Results: Significant improvements in pain relief, shoulder function, and functional scores were observed in both groups after surgery regardless of the suture anchor applied (P<0.001). No differences observed in the functional scores and range of motion. The assessments of UCLA scores at 3 and 6 months produced no statistical differences (P=0.885 and 0.340, respectively). The mean VAS scores in group 1 did not reveal statistical differences at 3 and 6 months after surgery compared to group 2. No significant differences in the range of motion were found at each follow-up time-point and no shifting or breakage of the anchors occurred between the two groups (P>0.01). No major intra-or post-operative complications, such as infection, and vessel or nerve injury. Conclusions: Pain relief and shoulder function were improved after complete rotator cuff repair in both groups, regardless of the suture anchor applied. The difference in functional scores and range of motion were not significant in groups 1 and 2. Delta Medical's PEEK suture anchor had a non-inferiority effectcompared to Smith & Nephew's PEEK suture anchor. Delta Medical's PEEK suture anchor was suitable for arthroscopic rotator cuff repair. Trial registration: Chinese Clinical Trial Registry ChiCTR2100051716.
基金:
Scientific Research Project of Hunan Provincial Health Special Fund (A2020-02, P Gao); the Hunan Province Technological Innovation Guidance Plan-Clinical Medical Technology Innovation Guidance Project (2018SK50725, HT Wang); and the Key R&D Program of Hunan Province (2020SK2117, J Wang).
第一作者机构:[1]Hunan Normal Univ, Affiliated Hosp 1, Hunan Prov Peoples Hosp, Dept Joint Surg & Sports Med, Changsha, Peoples R China
共同第一作者:
通讯作者:
通讯机构:[1]Hunan Normal Univ, Affiliated Hosp 1, Hunan Prov Peoples Hosp, Dept Joint Surg & Sports Med, Changsha, Peoples R China[5]Hunan Univ Med, Affiliated Hosp Tradit Chinese Med, Tradit Chinese Med Hosp, Dept Orthoped, Huaihua, Peoples R China[*1]Department of Orthopedics, Traditional Chinese Medicine Hospital of Huaihua (Affiliated Hospital of Traditional Chinese Medicine, Hunan University of Medicine), Huaihua, China[*2]Department of Joint Surgery and Sports Medicine, Hunan Provincial People’s Hospital (The First-affiliated Hospital of Hunan Normal University), Changsha, China
推荐引用方式(GB/T 7714):
Gao Peng,Wang Hongtao,Xu Yongsheng,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[J].ANNALS OF TRANSLATIONAL MEDICINE.2021,9(24):doi:10.21037/atm-21-6008.
APA:
Gao, Peng,Wang, Hongtao,Xu, Yongsheng,Li, Yanlin,Cai, Guofeng...&Wang, Jing.(2021).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.ANNALS OF TRANSLATIONAL MEDICINE,9,(24)
MLA:
Gao, Peng,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".ANNALS OF TRANSLATIONAL MEDICINE 9..24(2021)