PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder

Browse trials for

• Joint Dislocations 98

Keywords

• Post-Market Clinical Follow-Up Study
• Medical Device
• Performance
• Safety
• Clinical Benefits

Joint Dislocations

98 studies on the registry are indexed under Joint Dislocations; 21 are open to participants now.

This study's enrollment of 214 is above the median of 100 across 37 observational studies indexed under Joint Dislocations.

Lead sponsor

Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.

Study population

Groups and cohorts

• ToggleLoc 2.9 mm soft tissue device

  Patients who already received the ToggleLoc 2.9 mm soft tissue device in the shoulder. No additional surgery will be performed.

  Device: ToggleLoc 2.9 mm soft tissue device

• JuggerLoc soft tissue device

  Patients who already received the JuggerLoc soft tissue device in the shoulder. No additional surgery will be performed.

  Device: JuggerLoc soft tissue device

Interventions

• DeviceToggleLoc 2.9 mm soft tissue device

  The ToggleLoc 2.9 mm Soft Tissue devices consist of non-resorbable devices intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation.

• DeviceJuggerLoc soft tissue device

  The JuggerLoc Soft Tissue devices consist of non-resorbable devices intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation.

Primary outcomes

1. Number of Participants With Evidence of Soft Tissue-to-Bone Healing in the Shoulder

   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.

   Time frame: 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)

Secondary outcomes

1. Number of Participants With Revision Surgery

   Safety will be evaluated by recording and analyzing the incidence of revisions. A Kaplan-Meier survival curve will be calculated. Revisions were defined as any subsequent surgical intervention involving removal, replacement, or modification of the index implant. Data were analyzed descriptively and using Kaplan-Meier survival analysis to estimate the probability of remaining revision-free over time. Results represent the number of participants who underwent at least one revision during follow-up.

   Time frame: 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.

2. EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L)

   Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs). This standardized instrument includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573; negative numbers correspond to a self-assessed health state. The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine').

   Time frame: 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

3. Oxford Shoulder Score (OSS)

   Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs). The Oxford Shoulder Score (OSS) is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following shoulder arthroplasty. The OSS consists of twelve questions covering function and pain. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome), and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as: Satisfactory Joint Function: 40 - 48, Moderate-Mild Arthritis: 30 - 39, Moderate-Severe Arthritis: 20 - 29, Severe Arthritis: 0 - 19.

   Time frame: 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.

Baseline characteristics

Study documents

• Protocol and statistical analysis plan ↗ · Dec 22, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No