Epicondylitis of the ElbowNCT05519228
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm in the Elbow
An observational study of Epicondylitis of the Elbow and Biceps Tendon Disorder, run by Zimmer Biomet at 2 sites in 2 countries.
Trial summary
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 Soft Tissue System when used for soft tissue to bone fixation in the elbow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epicondylitis of the Elbow, Biceps Tendon Disorder
- What is being tested?
- ToggleLoc 2.9 mm Soft Tissue System
- Type of treatment
- Medical device
- How many people
- 83 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Sep 2022to 20 Feb 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had required a soft tissue to bone fixation in the elbow with the ToggleLoc 2.9 mm Soft Tissue device according to Zimmer Biomet's Instruction for Use (IFU) and and who meet all the inclusions criteria and none of the exclusions criteria.
Who may be able to join
- Patients who received the ToggleLoc 2.9 mm Soft Tissue device for soft tissue to bone fixation in the elbow.
- 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.
Who cannot join
- 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 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm Soft Tissue System (Implants and Instrumentation) in the Elbow - A Multicenter Retrospective Consecutive Study
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 Soft Tissue System when used for soft tissue to bone fixation in the elbow. The primary objective is the assessment of performance by analyzing soft tissue to bone healing in the elbow.
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).
Read the detailed description
The ToggleLoc 2.9 mm Soft Tissue System consist of non-resorbable device 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 elbow requiring soft tissue to bone fixation and to relieve pain that cannot be controlled by other treatments.
Two sites will be involved in this study. The aim is to include a total of 83 consecutive series cases operated with the ToggleLoc 2.9 mm in the elbow. 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.
- Conditions
- Epicondylitis of the Elbow, Biceps Tendon Disorder
- Being tested
- ToggleLoc 2.9 mm Soft Tissue System
- Keywords
- Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToggleLoc 2.9 mm Soft Tissue SystemDevice
The ToggleLoc 2.9 mm Soft Tissue System consist of non-resorbable device intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation
| Study group | Role | What they receive |
|---|---|---|
| ToggleLoc 2.9 mm soft tissue device | Patients who already received the ToggleLoc 2.9 mm soft tissue device in the elbow. No additional surgery will be performed. Receives: Device: ToggleLoc 2.9 mm Soft Tissue System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft Tissue to Bone Healing in the Elbow - Hook Test
Assessment of performance by analyzing soft tissue to bone healing in the elbow. The principal investigator will clinically evaluate the study elbow to assess if soft tissue to bone healing has occurred using the Hook test.
The Hook test is performed by hooking the finger, that is inserted laterally under the biceps tendon, under the cord-like structure spanning the antecubital fossa with the patient's elbow flexed at 90 degrees.
Each case that a Hook test was performed on will be counted as 1 count and will be described as "1 case" if successful, meaning this case had successful soft tissue to bone healing.
Measured: From operation to the study completion, minimum 1 year post-op.
Secondary outcomes (3)
EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS)
Assessment of patient-reported outcome measures (PROMs): The EuroQol fivedimensional Health Questionnaire (EQ-5D-5L) is a generic instrument. The EQ-5D-5L VAS is scored on a 0 to 100 mm scale. 0 mm represents "the worst..." and 100 mm represents "the best health you can imagine".
Measured: At minimum 1 year post-op.
EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): EQ-5D-5L Profile
Assessment of patient-reported outcome measures (PROMs): The EuroQol fivedimensional Health Questionnaire (EQ-5D-5L) is a generic instrument. In the EQ-5D-5L Profile the highest score is 1 and the lowest score is -0.573; negative numbers correspond to a self-assessed health state worse than being dead.
Measured: At minimum 1 year post-op.
Oxford Elbow Score (OES)
Assessment of patient-reported outcome measures (PROMs): The Oxford Elbow Score (OES) consists of 12 questionnaire items with five original response options each and is specifically designed and developed for assessing outcomes of elbow surgery. The score will be on a scale from 0 (worst) to 48 (best).
Measured: At minimum 1 year post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start12 Sep 2022
- Primary completion27 Sep 2023
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epicondylitis of the ElbowStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan ACHAKRI, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519228
- Sponsor's protocol ID
- MDRG2017-89MS-72SM
- Status last verified
- Dec 2023
- First submitted
- 1 Jun 2022
- Last updated
- 30 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm Soft Tissue System (Implants and Instrumentation) in the Elbow - A Multicenter Retrospective Consecutive Study
- ClinicalTrials.gov ID
- NCT05519228
- Acronym / sponsor ID
- MDRG2017-89MS-72SM
- Conditions
- Epicondylitis of the Elbow, Biceps Tendon Disorder
- Keywords
- Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Posted 12 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Soft Tissue System when used for soft tissue to bone fixation in the elbow. The primary objective is the assessment of performance by analyzing soft tissue to bone healing in the elbow.
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).
Detailed description
The ToggleLoc 2.9 mm Soft Tissue System consist of non-resorbable device 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 elbow requiring soft tissue to bone fixation and to relieve pain that cannot be controlled by other treatments.
Two sites will be involved in this study. The aim is to include a total of 83 consecutive series cases operated with the ToggleLoc 2.9 mm in the elbow. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ToggleLoc 2.9 mm soft tissue device | – | Device: ToggleLoc 2.9 mm Soft Tissue SystemPatients who already received the ToggleLoc 2.9 mm soft tissue device in the elbow. No additional surgery will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had required a soft tissue to bone fixation in the elbow with the ToggleLoc 2.9 mm Soft Tissue device according to Zimmer Biomet's Instruction for Use (IFU) and and who meet all the inclusions criteria and none of the exclusions criteria.
Key inclusion criteria (3 listed)
- Patients who received the ToggleLoc 2.9 mm Soft Tissue device for soft tissue to bone fixation in the elbow.
- 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.
Key exclusion criteria (7 listed)
- 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 have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToggleLoc 2.9 mm Soft Tissue SystemThe ToggleLoc 2.9 mm Soft Tissue System consist of non-resorbable device intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation | Device | ToggleLoc 2.9 mm soft tissue device |
Primary outcome
Soft Tissue to Bone Healing in the Elbow - Hook Test
Time frame: From operation to the study completion, minimum 1 year post-op.
Assessment of performance by analyzing soft tissue to bone healing in the elbow. The principal investigator will clinically evaluate the study elbow to assess if soft tissue to bone healing has occurred using the Hook test. The Hook test is performed by hooking the finger, that is inserted laterally under the biceps tendon, under the cord-like structure spanning the antecubital fossa with the patient's elbow flexed at 90 degrees. Each case that a Hook test was performed on will be counted as 1 count and will be described as "1 case" if successful, meaning this case had successful soft tissue to bone healing.
3 secondary outcomes
EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS)
Time frame: At minimum 1 year post-op.
EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): EQ-5D-5L Profile
Time frame: At minimum 1 year post-op.
Oxford Elbow Score (OES)
Time frame: At minimum 1 year post-op.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan ACHAKRI study director
Zimmer Biomet
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epicondylitis of the Elbow and Biceps Tendon Disorder, run by Zimmer Biomet at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft Tissue to Bone Healing in the Elbow - Hook Test (time frame: From operation to the study completion, minimum 1 year post-op.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.