A Clinical Study to Evaluate the Safety and Efficacy of Q-Fix Trial in Chinese Patients — Q-Fix  

Arthroscopy Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Arthroscopy

• NCT number: NCT03765515
• Study type: Interventional
• Source: Smith & Nephew, Inc.
• Status: Completed
• Phase: N/A
• Start date: April 12, 2019
• Completion date: April 12, 2021