- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05491564
SoftStitch™ for All-Inside Meniscal Repair: Comparative Analysis of Patient Reported Outcome Measures
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Justin W Moss, DHSc
- Phone Number: 770 584 4972
- Email: justin.moss@arthrex.com
Study Contact Backup
- Name: Alicia Ruiz
- Email: alicia.ruiz@arthrex.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
Collected at baseline, 6 months post-op, 12 months post-op, and 24 months post-op. The changes from baseline will be assessed.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AIRR-0065
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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