Meniscal TearSTITCHNCT02237001

Study of Suture Repair of Torn Meniscus in the Knee

A study testing Suture-based meniscal repair in people with Meniscal Tear and Meniscus Tear, run by Smith & Nephew, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Horizontal meniscus tears meeting specified criteria will be repaired by any commonly used suture technique. Subjects will be followed for 2 years to evaluate the effectiveness of the repair, by assessing the re-operation rate, and by assessing improvements in knee pain and knee function. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Meniscal Tear, Meniscus Tear
What is being tested?: Suture-based meniscal repair
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 8 sitesUnited States
Study dates: 19 Nov 2014to 18 Nov 2019
Phase: Interventional
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 to 60 years
All sexes
No healthy volunteers
Adult

Screening Inclusion Criteria:

Subjects of either gender may be eligible for inclusion in the study only if they meet all of the following criteria:

Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board
18 to 60 years of age, inclusive at the time of screening;
History indicative of meniscal pathology (e.g., pain, mechanical symptoms described as locking, clicking or giving way);
Physical exam consistent with meniscus tear (e.g., locked joint, joint line tenderness and/or pain on meniscal compression);
If prior ligament reconstruction, the study knee is clinically stable;
Preoperative MRI evidence within 6 months consistent with a horizontal/radial/oblique meniscus tear in the symptomatic compartment

Arthroscopy Inclusion Criteria:

Consented subjects may be included in the study only if, upon arthroscopic inspection, their meniscal study lesion meets all of the following criteria established by the International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS) (see Appendix 1):

Zone location: circumferential location of tear includes locations within 10mm of the peripheral rim of the meniscus;
Radial location: any location from anterior to posterior;
Tear pattern: primarily horizontal or oblique in orientation (not to exceed 45 degrees from horizontal);
Compartment: either lateral or medial, but not both;
Opposite compartment meniscal tear (if present) limited to the central portion (i.e., Zone 3/"white zone");
Tear amenable to repair with all suture-based techniques.

Screening Exclusion Criteria:

Subjects will be excluded from the study for any of the following reasons:

Arthritis in the study knee (Kellgren-Lawrence Grade 3 or higher [See Appendix 4]);
Body Mass Index (BMI) ≥35 kg/m2;
Previous meniscal repair or meniscectomy of the study meniscus;
Unstable knee;
Malalignment (> 5 degrees) of the study knee, based on X-ray within 6 months requiring osteotomy and/or requiring correction;
History of constitutional/systemic inflammatory/arthritic problem or pain condition, history of knee infection, vascular condition of legs, benign neoplasms of knee, hepatitis, HIV, drug/alcohol abuse, tobacco use, cancer;
Expected to undergo any other primary treatment of the knee;
Any concomitant painful or disabling disease, condition or post-procedure status of either lower extremity that would interfere with evaluation or rehabilitation of the study knee.
Pregnant or planning to become pregnant in the next 2 years.

Arthroscopy Exclusion Criteria:

Subjects will be excluded from the study if their study meniscus lesion meets any of the following criteria at arthroscopy:

Tear pattern: primarily vertical longitudinal in orientation;
Partial meniscectomy of any portion of the study meniscus extends beyond the central portion (i.e., Zone 3/"white zone");
Intact or partially intact meniscus tear that, in the opinion of the Investigator, does not require repair;
Poor meniscal tissue quality such that it will not hold a suture;
Any portion of the meniscus repair that, in the opinion of the Investigator, is best treated using an implant other than suture;
Bicompartmental Zone 1/"red zone" and/or Zone 2/"red-white zone" meniscal tears;
Performance of a significant concomitant procedure intended as a therapeutic intervention on the study knee;
Arthritis in the surgical knee (International Cartilage Research Society [ICRS] Grade 3b or higher or Modified Outerbridge Grade III or higher)

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

University of Virginia
Charlottesville, Virginia, 22908
The Ohio State University
Columbus, Ohio, 43221
CORE Orthopaedic Medical Center
Encinitas, California, 92024
OrthoIndy South
Greenwood, Indiana, 46143
Andrews Research and Education Foundation, INC
Gulf Breeze, Florida, 32561
Memorial Orthopedic Surgical Group Long Beach
Long Beach, California, 90806
Mayo Clinic
Rochester, Minnesota, 55905
Winchester Medical Center
Winchester, Virginia, 22601

Other trials in United States

About this study

Official title: A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears (STITCH Study)

Read the detailed description

Potential subjects will undergo Screening for eligibility based on Inclusion/Exclusion criteria. Screening will include an x-ray of the injured knee and evaluation of an MRI of the injured knee within 6 months prior to the scheduled procedure. During the procedure, the meniscal tear will be evaluated by arthroscopy to determine if the tear meets study requirements. If the meniscal tear is determined to meet inclusion/exclusion criteria, the subject will be considered enrolled. If any inclusion/exclusion criteria is not met, the subject will be considered a screen failure and will not be enrolled. For enrolled subjects, specific information regarding the repair and repair technique will be collected during the procedure, including still and video images.

Subjects will be contacted 7-15 days post-procedure for safety follow-up. Subjects will return for follow-up visits at approximately post-procedure Days 90, 185, 365 and 730. Identical questionnaires will be completed at each visit to assess knee pain and knee function. Safety information will be collected at each post-procedure visit. Additionally, an in-office arthroscopy of the treated knee will be performed at participating sites at Day 185, an MRI of the treated knee will be performed at Day 365 and an X-ray of the treated knee will be performed at Day 730. The patient will exit the study at the Day 730 visit.

Conditions: Meniscal Tear, Meniscus Tear
Being tested: Suture-based meniscal repair
Keywords: meniscal, meniscus, repair, knee, arthroscopy knee, horizontal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Suture-based meniscal repairDevice
Suture-based meniscal repair

Study groups in NCT02237001
Study group	Role	What they receive
Treatment	Experimental	Suture-based meniscal repair Receives: Device: Suture-based meniscal repair

What is being measured

The primary outcome is the main question the study is designed to answer.

Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)
Occurrence of any re-operation of study knee to treat previously repaired meniscal tear during the 2 years following the study procedure.
Measured: 6 months, 1 year, and 2 years

Secondary outcomes (8)

Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years
Change in knee pain and function will be measured by completion of The International Knee Documentation Committee (IKDC) Subjective score. The IKDC Score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries.
There are three domains: 1) symptoms, including pain, stiffness, swelling, locking/catching, and giving way (7 items), 2) sports and daily activities (10 items), and 3) current knee function and knee function prior to knee injury (1 item, not included in the score). Responses vary for each item. The possible score ranges from 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms.
Measured: Baseline, 3 months, 6 months, 1 year, and 2 years
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years
Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
Measured: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
Measured: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years
Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
Measured: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years
Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
Measured: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Quality of Life (QOL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
Measured: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Knee Pain and Function by Lysholm Knee Questionnaire at 3 Months, 6 Months, 1 Year, and 2 Years
Change in knee pain and function will be measured by completion of the Lysholm Knee Questionnaire. This tool measures the domains of symptoms and complaints and functioning of daily activities. The scale consists of 8 item and is scaled from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning.
Measured: Baseline, 3 months, 6 months, 1 year, and 2 years
Change in Knee Pain and Function by Tegner Activity Scale at 3 Months, 6 Months, 1 Year, and 2 Years
Change in knee pain and function will be measured by completion of the Tegner activity scale. The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The Tegner activity scale is a numerical scale ranging from 0 to 10. Each value indicates the ability to perform specific activities. An activity level of 10 corresponds to participation in competitive sports, including soccer, football, and rugby at the elite level; an activity level of 6 points corresponds to participation in recreational sports; and an activity level of 0 is assigned if a person is on sick leave or receiving a disability pension because of knee problems. An activity level of 5 to 10 is recorded only if the patient participates in recreational or competitive sports.
Measured: Baseline, 3 months, 6 months, 1 year, and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 201418 Nov 2019

First posted11 Sep 2014 (estimated)
Study start19 Nov 2014
Primary completion18 Nov 2019
Study completion18 Nov 2019

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Meniscal TearStudies of the same condition, open and under way.
More trials run by Smith & Nephew, Inc.The 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02237001
Sponsor's protocol ID: CTX-CP001
Acronym: STITCH
Status last verified: Nov 2020
First submitted: 6 Sep 2014
Last updated: 4 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Kurzweil PR, Lynch NM, Coleman S, Kearney B. Repair of horizontal meniscus tears: a systematic review. Arthroscopy. 2014 Nov;30(11):1513-9. doi: 10.1016/j.arthro.2014.05.038. Epub 2014 Aug 6.
PubMed 25108905

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears (STITCH Study)
ClinicalTrials.gov ID: NCT02237001
Acronym / sponsor ID: STITCH / CTX-CP001
Conditions: Meniscal Tear, Meniscus Tear
Keywords: meniscal, meniscus, repair, knee, arthroscopy knee, horizontal
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 19 Nov 2014 (actual)
Primary completion: 18 Nov 2019 (actual)
Study completion: 18 Nov 2019 (actual)
First posted: 11 Sep 2014 (estimated)
Results: Posted 27 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Device: Suture-based meniscal repairSuture-based meniscal repair

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

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
Suture-based meniscal repairSuture-based meniscal repair	Device	Treatment

Primary outcome

Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)
Time frame: 6 months, 1 year, and 2 years
Occurrence of any re-operation of study knee to treat previously repaired meniscal tear during the 2 years following the study procedure.

8 secondary outcomes

Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years
Time frame: Baseline, 3 months, 6 months, 1 year, and 2 years
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Quality of Life (QOL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Knee Pain and Function by Lysholm Knee Questionnaire at 3 Months, 6 Months, 1 Year, and 2 Years
Time frame: Baseline, 3 months, 6 months, 1 year, and 2 years
Change in Knee Pain and Function by Tegner Activity Scale at 3 Months, 6 Months, 1 Year, and 2 Years
Time frame: Baseline, 3 months, 6 months, 1 year, and 2 years

Results and safety

Results posted to the registry on 27 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	30	19

Primary outcome: Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)

Time frame: 6 months, 1 year, and 2 years. Count of participants. Unit: Participants

Measure	Treatment n = 27
Freedom from re-operation at 6 months: Participants Free From Re-operation	26
Freedom from re-operation at 6 months: Participants Requiring Re-operation	1
Freedom from re-operation at 1 year: Participants Free From Re-operation	23
Freedom from re-operation at 1 year: Participants Requiring Re-operation	2
Freedom from re-operation at 2 years: Participants Free From Re-operation	19
Freedom from re-operation at 2 years: Participants Requiring Re-operation	4

Population analysed: Overall number of participants analyzed indicates total number of participants enrolled in the Safety Population (SAF) at 6 months that provided data. Number analyzed for each time frame indicates all data available starting at 6 months.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Enrollment through end of study (2 years). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	4 of 30 (13.3%)	7 of 30 (23.3%)	0 of 30

Limitations and caveats (from the sponsor): No limitations reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25108905Kurzweil PR, Lynch NM, Coleman S, Kearney B. Repair of horizontal meniscus tears: a systematic review. Arthroscopy. 2014 Nov;30(11):1513-9. doi: 10.1016/j.arthro.2014.05.038. Epub 2014 Aug 6.
Individual participant dataSharing planned: No

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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.

Peter R Kurzweil, MD principal investigator

Memorial Orthopedic Surgical Group Long Beach

Darvin Griffin study chair

Smith & Nephew, Inc.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Suture-based meniscal repair in people with Meniscal Tear and Meniscus Tear, run by Smith & Nephew, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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 27 Oct 2020). 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?

Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation) (time frame: 6 months, 1 year, and 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02237001, which also lists 1 linked publication.

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 4 Dec 2020.