NCT03765515

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Arthroscopy

Interventions

Type	Name	Description
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.
DEVICE	Q-Fix	Q-Fix

Timeline

• Start date: 2019-04-12
• Primary completion: 2020-06-28
• Completion: 2021-04-12
• First posted: 2018-12-05
• Last updated: 2021-08-05

Locations

4 sites across 1 country: China