A Clinical Study to Evaluate the Safety and Efficacy of Q-Fix Trial in Chinese Patients
Condition: Arthroscopy
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      Study Duration: 24 months = 12 months of recruitment + 12 months of follow up (From the start
      of screening to the time that the last subject completes the trial) Primary endpoint:
      Constant score at 6 months after operation for the shoulder Secondary endpoint(s): ASES score
      Rowe score WORC questionnaire Incidence of rotator cuff re-tear Recurrence rate of shoulder
      joint instability Anchor pullout rate Adverse event Radiographic evaluation results Constant
      score Safety Data AEs, SAEs, ADEs, UADEs
    

Intervention name(s): Twinfix Ti; Q-Fix
Intervention type(s): Device; Device
Intervention description(s): 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.; Q-Fix
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial (RCT)
Masking: None (Open Label)
Primary purpose: Treatment