Meniscus TearNCT05491564
SoftStitch™ for All-Inside Meniscal Repair: Comparative Analysis of Patient Reported Outcome Measures
An observational study of Meniscus Tear, run by Arthrex, Inc..
Trial summary
Acute and traumatic knee meniscus tears are a frequent occurrence. Evidence shows meniscal repair results in more favorable patient reported outcomes and articular cartilage preservation.1 This prospective, multicenter, single cohort, longitudinal study is intended to evaluate the effectiveness and safety profile of… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Meniscus Tear
- What is being tested?
- SoftStitch™
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- Adult
Study population: Individuals recommended to undergo meniscal repair using SoftStitch™ in routine clinical practice will be considered for participation in this study. 50 subjects, male and female, ≥ 18 years old who have been legally consented and meet the eligibility criteria will be enrolled at the time of surgery. Subjects will be recruited from the principal investigator's patient population or referrals from other physicians.
Who may be able to join
- Confirmed meniscal tear by physical exam and MRI (minimum 1.5T)
- Recommended to undergo surgical intervention using SoftStitch™ for All-Inside meniscus repair of longitudinal tears on the posterior horn that a surgeon would traditionally repair with two or more all-inside devices, as standard of care
- Normal mechanical alignment; < 5° varus and < 7° valgus, of the affected knee by clinical assessment or X-Rays
- Male or female, ≥ 18 years old and ≤55
- Provide written informed consent
- Able and willing to participate in follow up visits
- Have a valid email and internet access to receive and respond to ePROs throughout the study
Who cannot join
- Meniscal tears which are not amendable to repair, such as degenerative, flap, radial, complex, etc.
- ACL-injured knees that are unstable (concomitant ACL reconstruction OK to include)
- Sensitivity to silicone, polyester, nylon, FD\&C Blue No. 2 dye and beeswax
- Blood supply limitations and previous or active6, joint or systemic, infections which may decrease healing
- Skeletally immature defined as patients with open epiphyseal plates viewed on radiographs
- Concomitant disease that would interfere with study outcomes
Show all 17Show fewer
- Congenital ligamentous hypermobility defined by Beighton score 4 or 5
- Locked knee or haemarthrosis7
- Mutiligament injuries requiring multiligament surgical stabilization
- Concomitant hybrid meniscal repair techniques or devices
- Advanced Osteoarthritis; Kellgren Lawrence ≥ 2
- Fracture of the lower extremities within 6 months prior to screening
- Previous surgery on the affected knee within 12 months prior to screening
- Subject is included in a vulnerable population (child, prisoner, etc).
- Subject is requesting or receiving Worker's compensation related to the knee injury
- Inability to reply to online questionnaires because of mental impairment
- Participation in another clinical investigation in the next two years
Trial locations and contacts
No sites are listed yet.
Alicia Ruiz contact
About this study
Acute and traumatic knee meniscus tears are a frequent occurrence. Evidence shows meniscal repair results in more favorable patient reported outcomes and articular cartilage preservation.1 This prospective, multicenter, single cohort, longitudinal study is intended to evaluate the effectiveness and safety profile of SoftStitch™ when used as standard of care for All-Inside Meniscal Repair. Electronic Patient Reported Outcome Measures (ePROM), functional assessments of the knee, Adverse Events of interest and Adverse Device Effects will be assessed.
- Conditions
- Meniscus Tear
- Being tested
- SoftStitch™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoftStitch™Device
The SoftStitch™ meniscal repair system includes a unique knotless all-inside meniscal repair implant with all suture fixation, eliminating the traditional hard plastic PEEK anchors used in the previous devices.
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm Score
It is a condition specific scoring system to provide the patient perspective of their illness. The Lysholm scoring scale currently consist of eight domains that measure: pain, instability, locking, swelling, limp, stair climbing, squatting, and need for support. The total score is the sum of all responses and ranges from 0-100 points with 95 to 100 as excellent outcome, 84 to 94 as good outcome, 65 to 83 as fair outocome and <65 as poor outcome.
Measured: Collected at baseline, 6 weeks, 3 months post-op, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
Tegner Activity Scale
It is a numerical scale that ranges from 0 - 10 to measure the ability to perform specific activities. An activity level of 5 to 10 is recorded only if the patient participates in competitive or recreational sports. That is, an activity level of 10 corresponds to participation in competitive sports such as soccer, football, and rugby at the elite level; an activity level of 6 points corresponds to participation is recreational sports. An activity level of 0 is assigned if a person is on sick leave or receiving a disability pension because of knee problems.
Measured: Collected at baseline, 6 weeks post-op, 3 months post-op, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
International Knee Documentation Committee (IKDC) Subjective Measure
The IKDC is a knee-specific subjective scale rather than a disease-specific measure. The IKDC to measure change in symptoms, sports activity, and function in patients with diverse knee conditions. The symptoms subscale evaluates pain, stiffness, swelling and giving-way of the knee. The sport activity subscale measures functions such as going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks the subject how well does the knee work now and before the injury. Individual scores are added and then transformed to a scale ranging from 0 to 100. The calculated IKDC score should be interpreted as a measure of function, such that high scores represent high levels of function and lower levels of symptoms. The instrument has demonstrated reliability and validity to measure patient reported outcomes.
Measured: Collected at baseline, 6 weeks post-op, 3 months post-op, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10
It is a ten-item global health questionnaire developed by the National Institutes of Health (NIH) to assess health-related quality of life compared with normal values in the U.S. general population. It measures five domains: physical function, fatigue, pain, emotional distress, and social health on a five-point response matrix. Nine of ten questions are answered using 5-point Likert scales, and the 10th question is answered using a numerical rating scale. The questionnaire does not yield an overall score but gives physical and mental health component scores that are transformed to t-score distributions with a mean of 50 and standard deviation of 10. The structure of the score should offer greater responsiveness to changes in general health. Responsiveness is defined as the ability of an instrument to measure change over time.
Measured: Collected at baseline, 6 weeks post-op, 3 months post-op, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
McMurray Test
It was designed to detect tears in the posterior segment of the meniscus. It is performed by placing the knee beyond 90° of flexion and then rotating the tibia on the femur into full internal rotation to test the lateral meniscus, or full external rotation to test the medical meniscus. The same movements are performed in gradually increasing degrees of knee flexion to progressively load more posterior segments of the menisci. No valgus or varus stress is applied. The surgeon will palpate the joint line medially and laterally. A positive test includes a thud or click that can sometimes be heard but can always be felt.
Measured: Collected at baseline, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Jul 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491564
- Sponsor's protocol ID
- AIRR-0065
- Status last verified
- Jan 2023
- First submitted
- 1 Aug 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SoftStitch™ for All-Inside Meniscal Repair: Comparative Analysis of Patient Reported Outcome Measures
- ClinicalTrials.gov ID
- NCT05491564
- Acronym / sponsor ID
- AIRR-0065
- Conditions
- Meniscus Tear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute and traumatic knee meniscus tears are a frequent occurrence. Evidence shows meniscal repair results in more favorable patient reported outcomes and articular cartilage preservation.1 This prospective, multicenter, single cohort, longitudinal study is intended to evaluate the effectiveness and safety profile of SoftStitch™ when used as standard of care for All-Inside Meniscal Repair. Electronic Patient Reported Outcome Measures (ePROM), functional assessments of the knee, Adverse Events of interest and Adverse Device Effects will be assessed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Individuals recommended to undergo meniscal repair using SoftStitch™ in routine clinical practice will be considered for participation in this study. 50 subjects, male and female, ≥ 18 years old who have been legally consented and meet the eligibility criteria will be enrolled at the time of surgery. Subjects will be recruited from the principal investigator's patient population or referrals from other physicians.
Key inclusion criteria (7 listed)
- Confirmed meniscal tear by physical exam and MRI (minimum 1.5T)
- Recommended to undergo surgical intervention using SoftStitch™ for All-Inside meniscus repair of longitudinal tears on the posterior horn that a surgeon would traditionally repair with two or more all-inside devices, as standard of care
- Normal mechanical alignment; < 5° varus and < 7° valgus, of the affected knee by clinical assessment or X-Rays
- Male or female, ≥ 18 years old and ≤55
- Provide written informed consent
Key exclusion criteria (17 listed)
- Meniscal tears which are not amendable to repair, such as degenerative, flap, radial, complex, etc.
- ACL-injured knees that are unstable (concomitant ACL reconstruction OK to include)
- Sensitivity to silicone, polyester, nylon, FD\&C Blue No. 2 dye and beeswax
- Blood supply limitations and previous or active6, joint or systemic, infections which may decrease healing
- Skeletally immature defined as patients with open epiphyseal plates viewed on radiographs
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 |
|---|---|---|
| SoftStitch™The SoftStitch™ meniscal repair system includes a unique knotless all-inside meniscal repair implant with all suture fixation, eliminating the traditional hard plastic PEEK anchors used in the previous devices. | Device | – |
Primary outcome
Lysholm Score
Time frame: Collected at baseline, 6 weeks, 3 months post-op, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
It is a condition specific scoring system to provide the patient perspective of their illness. The Lysholm scoring scale currently consist of eight domains that measure: pain, instability, locking, swelling, limp, stair climbing, squatting, and need for support. The total score is the sum of all responses and ranges from 0-100 points with 95 to 100 as excellent outcome, 84 to 94 as good outcome, 65 to 83 as fair outocome and <65 as poor outcome.
Tegner Activity Scale
Time frame: Collected at baseline, 6 weeks post-op, 3 months post-op, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
It is a numerical scale that ranges from 0 - 10 to measure the ability to perform specific activities. An activity level of 5 to 10 is recorded only if the patient participates in competitive or recreational sports. That is, an activity level of 10 corresponds to participation in competitive sports such as soccer, football, and rugby at the elite level; an activity level of 6 points corresponds to participation is recreational sports. An activity level of 0 is assigned if a person is on sick leave or receiving a disability pension because of knee problems.
International Knee Documentation Committee (IKDC) Subjective Measure
Time frame: Collected at baseline, 6 weeks post-op, 3 months post-op, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
The IKDC is a knee-specific subjective scale rather than a disease-specific measure. The IKDC to measure change in symptoms, sports activity, and function in patients with diverse knee conditions. The symptoms subscale evaluates pain, stiffness, swelling and giving-way of the knee. The sport activity subscale measures functions such as going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks the subject how well does the knee work now and before the injury. Individual scores are added and then transformed to a scale ranging from 0 to 100. The calculated IKDC score should be interpreted as a measure of function, such that high scores represent high levels of function and lower levels of symptoms. The instrument has demonstrated reliability and validity to measure patient reported outcomes.
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10
Time frame: Collected at baseline, 6 weeks post-op, 3 months post-op, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
It is a ten-item global health questionnaire developed by the National Institutes of Health (NIH) to assess health-related quality of life compared with normal values in the U.S. general population. It measures five domains: physical function, fatigue, pain, emotional distress, and social health on a five-point response matrix. Nine of ten questions are answered using 5-point Likert scales, and the 10th question is answered using a numerical rating scale. The questionnaire does not yield an overall score but gives physical and mental health component scores that are transformed to t-score distributions with a mean of 50 and standard deviation of 10. The structure of the score should offer greater responsiveness to changes in general health. Responsiveness is defined as the ability of an instrument to measure change over time.
McMurray Test
Time frame: Collected at baseline, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
It was designed to detect tears in the posterior segment of the meniscus. It is performed by placing the knee beyond 90° of flexion and then rotating the tibia on the femur into full internal rotation to test the lateral meniscus, or full external rotation to test the medical meniscus. The same movements are performed in gradually increasing degrees of knee flexion to progressively load more posterior segments of the menisci. No valgus or varus stress is applied. The surgeon will palpate the joint line medially and laterally. A positive test includes a thud or click that can sometimes be heard but can always be felt.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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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.
Alicia Ruiz contact
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Tear, run by Arthrex, Inc..
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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin W Moss, DHSc (770 584 4972, justin.moss@arthrex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm Score (time frame: Collected at baseline, 6 weeks, 3 months post-op, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.). The study lists 5 primary outcomes in all. 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 2 Feb 2023.