Knee Medial Meniscus TearsSTITCHRetroNCT03097744
Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs
An observational study of Knee Medial Meniscus Tears and Meniscus Lesion, run by Smith & Nephew, Inc. at 1 site in United States.
Trial summary
This is a retrospective study of meniscal tear repairs at least one-year post repair status. All patients were treated with Ceterix NovoStitch devices. The primary objectives of this study are to assess the clinical repair success rate via reoperation and PROs at greater than 12 months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Medial Meniscus Tears, Meniscus Lesion, Meniscus; Rupture, Bucket Handle
- What is being tested?
- Ceterix NovoStitch
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 20 Apr 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals, 18-years-old or older, who have undergone a meniscus repair with a Ceterix NovoStitch device at least 12 months ago.
Who may be able to join
- Able and willing to give consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements, local regulations, and Health Insurance Portability and Accountability Act (HIPAA) Authorization (or equivalent if locally applicable)
- In the opinion of the Investigator are able to comply with study-required follow-up
Who cannot join
- Post-operative interval <1year
- Concurrent bony fractures
- Post-operative reinjury (except the meniscus)
- Pre-operative arthritis grade 3 or higher on modified outerbridge
- Knee surgery prior to meniscus repair surgery
- Any kind of infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Agility Center Orthopedics
Bentonville, Arkansas, 72712
About this study
This is a retrospective study of meniscal tear repairs at least one-year post repair status. All patients were treated with Ceterix NovoStitch devices. The primary objectives of this study are to assess the clinical repair success rate via reoperation and PROs at greater than 12 months.
Read the detailed description
The study is a retrospective, non-randomized, single-group assignment, open-label study of repairs of meniscal tears status post repair. The following clinical efficacy endpoints will be evaluated at greater than 12 months:
- Reoperation rate
- Validated patient-reported outcomes measures
- Contribution of the following retrospective covariates on failure and outcomes when available: Type of tear, Location of tear (lateral versus medial), Chronicity of symptoms, Nature of tear (degenerative versus traumatic), Length of tear, Patient age, Patient gender, Length of rehabilitation protocol, Performance of trephination, Inclusion of biologic enhancement, Meniscal repair alone versus meniscal repair combined with ACL reconstruction.
- Conditions
- Knee Medial Meniscus Tears, Meniscus Lesion, Meniscus; Rupture, Bucket Handle, Meniscus Disorder
- Being tested
- Ceterix NovoStitch
- Keywords
- Lateral Meniscus Tear, Medial Meniscus Tear
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceterix NovoStitchDevice
The device allows the physician to place a circumferential compression stitch around meniscal tears. This stitch is placed by passing suture from the tibial side to the femoral side of the meniscus and across the tear. This allows compression across the entire tear surface.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation Rate
Data provided by patients
Measured: January 2015-February 2016
Validated patient-reported outcomes measures
IKDC Subjective
Measured: January 2015-February 2016
Contribution of the following retrospective covariates on failure and outcomes when available
Type of tear Location of tear (lateral versus medial), Chronicity of symptoms, Nature of tear (degenerative versus traumatic), Length of tear, Patient age, Patient gender, Length of rehabilitation protocol, Performance of trephination, Inclusion of biologic enhancement, Meniscal repair alone versus meniscal repair combined with ACL reconstruction
Measured: January 2015-February 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Feb 2017
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee Medial Meniscus TearsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathryn Olson, Study director, Ceterix Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097744
- Sponsor's protocol ID
- CTX-CP003
- Acronym
- STITCHRetro
- Status last verified
- Jan 2019
- First submitted
- 27 Mar 2017
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Saliman JD. The circumferential compression stitch for meniscus repair. Arthrosc Tech. 2013 Jul 12;2(3):e257-64. doi: 10.1016/j.eats.2013.02.016. eCollection 2013.
PubMed 24265995Nepple JJ, Dunn WR, Wright RW. Meniscal repair outcomes at greater than five years: a systematic literature review and meta-analysis. J Bone Joint Surg Am. 2012 Dec 19;94(24):2222-7. doi: 10.2106/JBJS.K.01584.
PubMed 23318612
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs
- ClinicalTrials.gov ID
- NCT03097744
- Acronym / sponsor ID
- STITCHRetro / CTX-CP003
- Conditions
- Knee Medial Meniscus Tears, Meniscus Lesion, Meniscus; Rupture, Bucket Handle, Meniscus Disorder
- Keywords
- Lateral Meniscus Tear, Medial Meniscus Tear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 31 Mar 2017 (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.
This is a retrospective study of meniscal tear repairs at least one-year post repair status. All patients were treated with Ceterix NovoStitch devices. The primary objectives of this study are to assess the clinical repair success rate via reoperation and PROs at greater than 12 months.
Detailed description
The study is a retrospective, non-randomized, single-group assignment, open-label study of repairs of meniscal tears status post repair. The following clinical efficacy endpoints will be evaluated at greater than 12 months:
- Reoperation rate
- Validated patient-reported outcomes measures
- Contribution of the following retrospective covariates on failure and outcomes when available: Type of tear, Location of tear (lateral versus medial), Chronicity of symptoms, Nature of tear (degenerative versus traumatic), Length of tear, Patient age, Patient gender, Length of rehabilitation protocol, Performance of trephination, Inclusion of biologic enhancement, Meniscal repair alone versus meniscal repair combined with ACL reconstruction.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals, 18-years-old or older, who have undergone a meniscus repair with a Ceterix NovoStitch device at least 12 months ago.
Key inclusion criteria (2 listed)
- Able and willing to give consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements, local regulations, and Health Insurance Portability and Accountability Act (HIPAA) Authorization (or equivalent if locally applicable)
- In the opinion of the Investigator are able to comply with study-required follow-up
Key exclusion criteria (6 listed)
- Post-operative interval <1year
- Concurrent bony fractures
- Post-operative reinjury (except the meniscus)
- Pre-operative arthritis grade 3 or higher on modified outerbridge
- Knee surgery prior to meniscus repair surgery
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 |
|---|---|---|
| Ceterix NovoStitchThe device allows the physician to place a circumferential compression stitch around meniscal tears. This stitch is placed by passing suture from the tibial side to the femoral side of the meniscus and across the tear. This allows compression across the entire tear surface. | Device | – |
Primary outcome
Reoperation Rate
Time frame: January 2015-February 2016
Data provided by patients
Validated patient-reported outcomes measures
Time frame: January 2015-February 2016
IKDC Subjective
Contribution of the following retrospective covariates on failure and outcomes when available
Time frame: January 2015-February 2016
Type of tear Location of tear (lateral versus medial), Chronicity of symptoms, Nature of tear (degenerative versus traumatic), Length of tear, Patient age, Patient gender, Length of rehabilitation protocol, Performance of trephination, Inclusion of biologic enhancement, Meniscal repair alone versus meniscal repair combined with ACL reconstruction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Background: PubMed 24265995Saliman JD. The circumferential compression stitch for meniscus repair. Arthrosc Tech. 2013 Jul 12;2(3):e257-64. doi: 10.1016/j.eats.2013.02.016. eCollection 2013.
- Background: PubMed 23318612Nepple JJ, Dunn WR, Wright RW. Meniscal repair outcomes at greater than five years: a systematic literature review and meta-analysis. J Bone Joint Surg Am. 2012 Dec 19;94(24):2222-7. doi: 10.2106/JBJS.K.01584.
- 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.
Kathryn Olson study director
Ceterix Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Medial Meniscus Tears and Meniscus Lesion, run by Smith & Nephew, Inc. at 1 site 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?
The sponsor lists 2 inclusion and 6 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 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reoperation Rate (time frame: January 2015-February 2016). The study lists 3 primary outcomes in all. 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 NCT03097744, which also lists 2 linked publications.
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 7 Sep 2020.