Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and the JuggerLoc™ Soft Tissue Systems (Implants and Instrumentation) in the Shoulder - A Multicenter Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 3
- 主要终点
- Number of Participants With Evidence of Soft Tissue-to-Bone Healing in the Shoulder
研究概览
简要总结
The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the ToggleLoc 2.9 mm and the JuggerLoc Soft Tissue Systems when used for soft tissue to bone fixation in the shoulder.
The primary objective is the assessment of performance by analyzing soft tissue to bone healing in the shoulder.
The secondary objective is the assessment of safety and clinical benefits. Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to device, instrumentation and/or procedure will be specified. Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs) at the longest follow-up after surgery (minimum one year).
详细描述
The ToggleLoc 2.9 mm and JuggerLoc Soft Tissue devices consist of non-resorbable devices intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation. The clinical purpose is to restore the function and flexibility of the shoulder requiring soft tissue to bone fixation and to relieve pain that cannot be controlled by other treatments.
Three sites will be involved in this study. The aim is to include a total of 206 (103 cases operated with the ToggleLoc 2.9 mm and 103 cases operated with the JuggerLoc in the shoulder) consecutive series cases. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop and intraop will be available in medical notes. The patients will be asked to complete patient questionnaires during a minimum 1 year follow up visit/phone call. In addition, any complications and adverse events that occured since the surgery will also be collected during the follow-up visit/phone call.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that received the ToggleLoc 2.9 mm and/or the JuggerLoc Soft Tissue devices for soft tissue to bone fixation in the shoulder.
- •Patients 18 years or older and skeletally mature.
- •Patients capable of understanding the surgeon's explanations and following his/her instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study.
排除标准
- •Infection.
- •Patient conditions including blood supply limitations, and insufficient quantity or quality of bone or soft tissue.
- •Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
- •Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation of the device.
- •Patients who are unwilling or unable to give consent, or to comply with the follow-up program.
- •Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.
- •Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
- •Off-label use.
结局指标
主要结局
Number of Participants With Evidence of Soft Tissue-to-Bone Healing in the Shoulder
时间窗: From operation to the study completion, minimum 1 year post-op. Through last available follow-up (mean = 2.1 years, range = 1.0-5.2 years for JuggerLoc; mean = 3.5 years, range = 1.0-7.0 years for ToggleLoc)
Assessment of performance by analyzing soft tissue to bone healing in the shoulder. The principal investigator will clinically evaluate the study shoulder to assess if soft tissue to bone healing has occurred using an assessment of pain. Healing was assessed by clinical examination at a minimum of 12 months post-operation. Soft tissue-to-bone healing was evaluated through clinical assessment at follow-up. Healing was defined as restoration of tendon attachment to bone without visible gap, pain, or functional limitation. Clinical evaluation included absence of pain on palpation and a satisfactory range of motion. Results represent the number of participants meeting these criteria for complete healing.
次要结局
- Number of Participants With Revision Surgery(From date of surgery to last available follow-up (mean follow-up = 2.1 ± 1.1 years for JuggerLoc and 3.5 ± 2.0 years for ToggleLoc), minimum 1 year post-op.)
- EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L)(From pre-operative baseline to last available follow-up (mean follow-up = 2.1 ± 1.1 years for JuggerLoc and 3.5 ± 2.0 years for ToggleLoc). Minimum 1 year post-operative)
- Oxford Shoulder Score (OSS)(From pre-operative baseline to last available follow-up (mean follow-up = 2.1 ± 1.1 years for JuggerLoc and 3.5 ± 2.0 years for ToggleLoc), minimum 1 year post-op.)