A Clinical Study to Evaluate the Safety and Efficacy of Q-Fix Trial in Chinese Patients (Q-Fix)
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|ClinicalTrials.gov Identifier: NCT03765515|
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : August 7, 2019
Protocol synopsis Title of Study: A Prospective, Randomized, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of Q-Fix All-Suture Anchor in Arthroscopic Repair of Shoulder Soft Tissue in Chinese Patients
Study Design: Prospective, multicenter, comparative, randomized, concurrent control Study Type: Randomized Controlled Trial (RCT) Study Product: Q-Fix All-Suture Anchor Comparison Group Twinfix Ti Suture Anchor Study Purpose: The purpose of this study is to evaluate the safety and efficacy of Q-Fix All-suture Anchor in patients requiring the repair of soft tissue of shoulder who receive the arthroscopic repair of soft tissue using Q-Fix All-suture Anchor, when compared with the patients receiving the treatment with Twinfix Ti Suture Anchor. The result of this trial will be used for the Q-Fix All-suture Anchor registration in China.
Primary Objective: The primary objective of this study is to confirm that the clinical outcome of subjects receiving the treatment with Q-Fix All-suture Anchor is non-inferior to that of the subjects receiving the treatment with Twinfix Ti Suture Anchor during the same period, at 6 months after the repair of soft tissue of shoulder, taking the mean Constant score as efficacy endpoint.
Secondary Objective(s): The secondary objective of this study is to determine the safety and efficacy of Q-Fix All-suture Anchor at 12 months after repair of soft tissue of shoulder.
Statistical Rationale: The primary efficacy endpoint of this study is Constant score at 6 months after operation. The non-inferiority testing is performed for efficiency of primary efficacy endpoint; the test hypothesis is as follows:
Invalid hypothesis: H0: μ1-μ2 ≤ -δ Alternative hypothesis: H1: μ1-μ2 > -δ Where, μ1 and μ2 are the mean Constant scores in the test and control group, respectively. δ is the non-inferiority margin, which is set to 10. The hypothesis will be tested by two-sided t-test at the alpha level of α=0.025 (one-tailed test). the A non-inferior test will be conducted on the Constant scores in the test and control groups. The 95% confidence interval for the difference between two groups will be calculated. If the lower limit of 95%CI for the efficiency difference between two groups is greater than -9, it is considered that the test group is non-inferior to the control group.
Sample Size: 128 (64 in each group) Number of Study Sites: Approximate 5 clinical sites Targeted Global Regions: China
|Condition or disease||Intervention/treatment||Phase|
|Arthroscopy||Device: Twinfix Ti Device: Q-Fix||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Controlled Trial (RCT)|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of Q-Fix All-Suture Anchor in Arthroscopic Repair of Shoulder Soft Tissue in Chinese Patients|
|Actual Study Start Date :||April 12, 2019|
|Estimated Primary Completion Date :||November 17, 2021|
|Estimated Study Completion Date :||December 3, 2021|
Q-Fix has the advantages of all-suture implant and has the same or better performance than the traditional anchor.
Active Comparator: Twinfix Ti
The Smith & Nephew's marketed Twinfix Suture Anchor is selected as the control product. This product is composed of anchor, suture, suture needle and inserter. The anchor is made of Ti6Al4V titanium alloy conforming to ISO5832-3. The Durabraid suture is made of polyester (Polyethylene terephthalate) conforming to YY 0167. Ultrabraid suture is made of two materials of UHMWPE and polypropylene monofilaments conforming to GB/T 19701.1. The suture needle is made of Type 420B stainless steel conforming to YY/T 0726. The stem portion of inserter that comes into contact with the body is made of Type 630B stainless steel conforming to YY/T 0726.
Device: Twinfix Ti
The purpose is to evaluate the safety and efficacy of Q-Fix in patients requiring the repair of soft tissue of shoulder who receive the arthroscopic repair of soft tissue using Q-Fix, when compared with the patients receiving the treatment with Twinfix Ti Suture Anchor. The result of this trial will be used for the Q-Fix All-suture Anchor registration in China.
- The Constant-Murley score at 6 months after operation. [ Time Frame: at 6 months after operation. ]Confirming Q-Fix is non-inferior to Twinfix, at 6 months after the repair of soft The Constant score is a 100 points scale consisting of four variables, which includes a patient reported part (pain 15 points and activity level 20 points), which results in a total of 35 points. Next to this there is a physician rated part (shoulder strength 25 points and range of motion 40 points) which totals 65 points.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765515
|Contact: Brook NA Li||+86 10 64198395||Brook.Li@smith-nephew.com|
|Contact: Jinhua NA Zhou, Master||021-23303135 ext 3135||Stephen.Zhou@smith-nephew.com|
|Foshan Hospital of TCM||Recruiting|
|Foshan, Guangdong, China, 528000|
|Contact: Lilian NA Zhao, Doctor|
|Hunan Provincial People's Hospital||Not yet recruiting|
|Changsha, Hunan, China, 410005|
|Contact: Jing NA Wang, Doctor|
|2nd Affiliated Hospital of Zhejiang University School of Medicine||Not yet recruiting|
|Hangzhou, Zhejiang, China, 310009|
|Contact: Xuesong NA Dai, Doctor|
|Peking University Third Hospital||Not yet recruiting|
|Beijing, China, 100191|
|Contact: Hui NA Yan, Doctor|
|Principal Investigator:||Hui NA Yan, Doctor||Peking University Third Hospital|