Meniscus TearNOVOSTITCH PRONCT04361487
Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears
An observational study of Meniscus Tear and Retention; Meniscus, run by Smith & Nephew, Inc. at 6 sites in United States.
Trial summary
The purpose of this study is to understand the benefits and safety of the NOVOSTITCH PRO Meniscal Repair (NOVOSTITCH PRO) system. The meniscus is a tissue in the knee joint. The NOVOSTITCH PRO is used during surgery to fix meniscus tears in the knee. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Meniscus Tear, Retention; Meniscus
- What is being tested?
- NOVOSTITCH™ PRO Meniscal Repair System
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Nov 2020to 25 Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited at the sports medicine/orthopedic clinic.
Who may be able to join
- Subjects will be eligible for the study if they meet all of the following criteria at the Baseline Screening:
- Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board;
- 18 to 70 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;
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- Meniscal repair to be performed arthroscopically;
- Preoperative MRI evidence consistent with a horizontal cleavage or complex meniscus tear in the symptomatic compartment;
- Willing and able to comply with all study procedures and visit requirements, including MRIs, X-rays, and Case Report Forms (CRFs) completed by the subject.
- Consented subjects may be included in the study only if, upon arthroscopic inspection during the procedure, their meniscal study lesion meets all of the following criteria:
- Meniscal tear amenable to repair with NOVOSTITCH PRO with or without the use of adjunct devices per the exclusion criteria;
- Tear pattern is one of the following:
- Horizontal cleavage tear (HCT), or
- Complex multi-planar tear (combination of at least two of the following tears: horizontal, oblique, radial, vertical).
Who cannot join
- Subjects will be excluded from the study if they meet any of following criteria at the Baseline Screening:
- Arthritis in the study knee (Kellgren-Lawrence Grade 3 or higher);
- Body Mass Index (BMI) ≥40 kg/m2;
- Previous surgical meniscal repair or meniscectomy of the study meniscus;
- Unstable knee;
- Clinically significant malalignment of the study knee, and/or requiring osteotomy, and/or correction;
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- History of constitutional/systemic inflammatory/arthritic problem or pain condition, history of knee infection, vascular condition of legs, benign neoplasms of knee, hepatitis, and/or HIV;
- Currently on any immunosuppressive therapy;
- Expected to undergo any other surgical treatment of either knee;
- Previously enrolled in the study (no bilateral knee surgeries);
- Surgical procedures other than those listed in the Indications for Use;
- Patient conditions including insufficient quantity or quality of tissue;
- Insufficient blood supply or previous infections which may hinder the healing process;
- Foreign body sensitivity. If material sensitivity is suspected, testing should be completed prior to suture implantation;
- Conditions which may limit the patient's ability or willingness to follow postoperative care instructions;
- 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;
- Subject does not understand a language in which the PROs and EQ-5D-5L are available.
- Subjects will be excluded from the study if their study meniscus lesion meets any of the following criteria at arthroscopy:
- Ramp tears;
- Root or other tear type requiring tibial fixation;
- Tears requiring repair of both meniscus in the study knee;
- 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;
- For HCTs:
- Use of any capsular fixation device; OR
- Any portion of the meniscal tear is repaired using a device to place stitches other than NOVOSTITCH PRO, Meniscus Mender II, or Meniscal Stitcher, or FIRSTPASS MINI marketed by Smith + Nephew Inc.;
- For complex tears:
- Any portion of the meniscal tear is repaired using a device to place stitches other than NOVOSTITCH PRO, Meniscus Mender II, Meniscal Stitcher, FIRSTPASS MINI, FAST-FIX 360, or ULTRA FAST-FIX marketed by Smith + Nephew Inc.;
- Clinically significant (zone 1 and/or zone 2) tear in the contralateral compartment to the study meniscus;
- Performance of a significant concomitant procedure (e.g. ACL reconstruction or repair, cartilage repair or restoration) intended as a therapeutic intervention on the study knee;
- Presence of infection;
- Articular cartilage damage in the study knee, defined as Modified Outerbridge Grade III or higher.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Rush University Medical Center / Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
Ohio State University/Jameson Crane Sports Medicine Institute
Columbus, Ohio, 43202
Hawai'i Pacific Health / Straub Medical Center
Honolulu, Hawaii, 96813
University of Kansas Medical Center
Overland Park, Kansas, 66211
Mayo Clinic
Rochester, Minnesota, 55905
CAO Research Foundation
Washington D.C., District of Columbia, 20037
About this study
The purpose of this study is to understand the benefits and safety of the NOVOSTITCH PRO Meniscal Repair (NOVOSTITCH PRO) system. The meniscus is a tissue in the knee joint. The NOVOSTITCH PRO is used during surgery to fix meniscus tears in the knee. It is unknown whether fixing a meniscus tear is better than the approach of removing the tear. Data will be collected on participants prior to surgery, at surgery, and for 2 years after surgery.
Read the detailed description
The purpose of this study is to understand the benefits and safety of the NOVOSTITCH PRO Meniscal Repair (NOVOSTITCH PRO) system. The meniscus is a tissue in the knee joint. The NOVOSTITCH PRO is used during surgery to fix meniscus tears in the knee. It is unknown whether fixing a meniscus tear is better than the approach of removing the tear. Data will be collected on participants prior to surgery, at surgery, and for 2 years after surgery.
There are different types of tears in the meniscus. This study includes 2 of the tear types: horizontal cleavage and complex meniscal tears.
Participants will be consented and enrolled in the study prior to knee surgery. Participants will complete surveys before surgery and data obtained from the medical record. In addition, standard of care x-rays and MRIs of the knee will be sent to the study. Participants will have their standard of care surgery to repair the knee using NOVOSTITCH PRO. Images and videos inside the knee during surgery may be sent to the study.
Participants will be followed 2 years after surgery. There are a total of 5 follow-up visits: 2 weeks, 3 months, 6 months, 1 year, and 2 years after surgery. Data will be obtained from medical records, surveys, MRIs, and radiographs. Up to 30 participants will have an optional needle endoscopy at the 6-month follow-up visit.
- Conditions
- Meniscus Tear, Retention; Meniscus
- Being tested
- NOVOSTITCH™ PRO Meniscal Repair System
- Keywords
- NOVOSTITCH, meniscal, meniscus, repair, knee, horizontal cleavage, complex tear, arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVOSTITCH™ PRO Meniscal Repair SystemDevice
Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System
| Study group | Role | What they receive |
|---|---|---|
| NOVOSTITCH™ PRO Meniscal Repair System | Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System Receives: Device: NOVOSTITCH™ PRO Meniscal Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Freedom From Reoperation at 12 Months After Surgery
Percentage of participants with freedom from reoperation due to meniscal repair failure at 12 months after surgery (i.e., no re-operation required). Freedom from reoperation was defined as no re-operation required due to meniscal repair failure for any reason.
Measured: 12 months
Secondary outcomes (12)
Rate of Freedom From Reoperation at 6 & 24 Months After Surgery
Percentage of participants with freedom from reoperation due to meniscal repair failure at 6 months \& 24 months after surgery (i.e., no re-operation required). Freedom from reoperation was defined as no re-operation required due to meniscal repair failure for any reason.
Measured: 6 months, 24 months
Structural Integrity of Meniscus Assessed by MRI
Structural integrity of the meniscus was identified using Magnetic Resonance Imaging (MRI) by the results of the Meniscal Signal Index Meniscus grading. Participants were categorized using the following grading:
- Grade 0: Low signal intensity indicative of a normal meniscus.
- Grade 1: Irregularly marginated elevated signal with globular shape, suggestive of early meniscal degeneration.
- Grade 2: Linear elevated signal (i.e. confirmed fluid signal) not extending into the tibial or femoral articular surface.
- Grade 3: Linear elevated signal (i.e. confirmed fluid signal) extending into the tibial or femoral articular surface, suggestive of a tear
Measured: Baseline, 12 months, and 24 months
Change in Tibiofemoral Joint Space Narrowing (JSN) in Medial Compartment From Baseline to 24 Months
Change in Tibiofemoral Joint Space Narrowing (JSN) in the medial compartment was measured in millimeters (mm) as assessed by x-rays.
Measured: Baseline to 24 months
Change in Tibiofemoral Joint Space Narrowing (JSN) in Lateral Compartment From Baseline to 24 Months
Change in Tibiofemoral Joint Space Narrowing (JSN) in the lateral compartment was measured in millimeters (mm) as assessed by x-rays.
Measured: Baseline to 24 months
In-Office Needle Endoscopy at 6 Months
In-office needle endoscopy is a minimally invasive procedure in which a needle-sized camera is inserted into tissue for observation and/or biopsy purposes. For this study, a needle-sized endoscopy was inserted to record video and images of the meniscal repair site and visually assess healing. Healing by participant was categorized as:
- Healed
- Incompletely Healed
- Failure
Measured: 6 months
Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score
The International Knee Documentation Committee (IKDC) Subjective score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries. Possible scores range from 0-100, where 100 indicated the highest level of function and lowest level of symptoms (i.e., better outcome), and 0 indicated the lowest level of function or highest level of symptoms (i.e., worse outcome).
Measured: Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms Score
The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items).
A Likert scale is used for each subscale with 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 (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Score
The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items).
A Likert scale is used for each subscale with 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 (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life Score
The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items).
A Likert scale is used for each subscale with 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 (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport Score
The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items).
A Likert scale is used for each subscale with 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 (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life Score
The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items).
A Likert scale is used for each subscale with 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 (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
Measured: Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Lysholm Knee Scoring Scale Score
The Lysholm Knee Scoring Scale measures the participant's symptoms and functioning of daily activities by assessing 8 items: limping, using cane or crutches, locking sensation in the knee, giving way sensation from the knee, pain, swelling, climbing stairs, and squatting. The scale is scored on a scale from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning (i.e., a better outcome).
Measured: Baseline, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start13 Nov 2020
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Why it stopped: Slow enrollment resulted in the decision to prematurely terminate the study
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 Meniscus 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karlie Morgan, BS CCRP, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361487
- Sponsor's protocol ID
- NOVOSTITCH.2019.09
- Acronym
- NOVOSTITCH PRO
- Status last verified
- Nov 2024
- First submitted
- 22 Apr 2020
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears
- ClinicalTrials.gov ID
- NCT04361487
- Acronym / sponsor ID
- NOVOSTITCH PRO / NOVOSTITCH.2019.09
- Conditions
- Meniscus Tear, Retention; Meniscus
- Keywords
- NOVOSTITCH, meniscal, meniscus, repair, knee, horizontal cleavage, complex tear, arthroscopy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment resulted in the decision to prematurely terminate the study
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Posted 24 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand the benefits and safety of the NOVOSTITCH PRO Meniscal Repair (NOVOSTITCH PRO) system. The meniscus is a tissue in the knee joint. The NOVOSTITCH PRO is used during surgery to fix meniscus tears in the knee. It is unknown whether fixing a meniscus tear is better than the approach of removing the tear. Data will be collected on participants prior to surgery, at surgery, and for 2 years after surgery.
Detailed description
The purpose of this study is to understand the benefits and safety of the NOVOSTITCH PRO Meniscal Repair (NOVOSTITCH PRO) system. The meniscus is a tissue in the knee joint. The NOVOSTITCH PRO is used during surgery to fix meniscus tears in the knee. It is unknown whether fixing a meniscus tear is better than the approach of removing the tear. Data will be collected on participants prior to surgery, at surgery, and for 2 years after surgery.
There are different types of tears in the meniscus. This study includes 2 of the tear types: horizontal cleavage and complex meniscal tears.
Participants will be consented and enrolled in the study prior to knee surgery. Participants will complete surveys before surgery and data obtained from the medical record. In addition, standard of care x-rays and MRIs of the knee will be sent to the study. Participants will have their standard of care surgery to repair the knee using NOVOSTITCH PRO. Images and videos inside the knee during surgery may be sent to the study.
Participants will be followed 2 years after surgery. There are a total of 5 follow-up visits: 2 weeks, 3 months, 6 months, 1 year, and 2 years after surgery. Data will be obtained from medical records, surveys, MRIs, and radiographs. Up to 30 participants will have an optional needle endoscopy at the 6-month follow-up visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOVOSTITCH™ PRO Meniscal Repair System | – | Device: NOVOSTITCH™ PRO Meniscal Repair SystemParticipants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited at the sports medicine/orthopedic clinic.
Key inclusion criteria (14 listed)
- Subjects will be eligible for the study if they meet all of the following criteria at the Baseline Screening:
- Consented subjects may be included in the study only if, upon arthroscopic inspection during the procedure, their meniscal study lesion meets all of the following criteria:
Key exclusion criteria (33 listed)
- Subjects will be excluded from the study if they meet any of following criteria at the Baseline Screening:
- Subjects will be excluded from the study if their study meniscus lesion meets any of the following criteria at arthroscopy:
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 |
|---|---|---|
| NOVOSTITCH™ PRO Meniscal Repair SystemStandard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System | Device | NOVOSTITCH™ PRO Meniscal Repair System |
Primary outcome
Rate of Freedom From Reoperation at 12 Months After Surgery
Time frame: 12 months
Percentage of participants with freedom from reoperation due to meniscal repair failure at 12 months after surgery (i.e., no re-operation required). Freedom from reoperation was defined as no re-operation required due to meniscal repair failure for any reason.
12 secondary outcomes
Rate of Freedom From Reoperation at 6 & 24 Months After Surgery
Time frame: 6 months, 24 months
Structural Integrity of Meniscus Assessed by MRI
Time frame: Baseline, 12 months, and 24 months
Change in Tibiofemoral Joint Space Narrowing (JSN) in Medial Compartment From Baseline to 24 Months
Time frame: Baseline to 24 months
Change in Tibiofemoral Joint Space Narrowing (JSN) in Lateral Compartment From Baseline to 24 Months
Time frame: Baseline to 24 months
In-Office Needle Endoscopy at 6 Months
Time frame: 6 months
Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score
Time frame: Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms Score
Time frame: Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Score
Time frame: Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life Score
Time frame: Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport Score
Time frame: Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life Score
Time frame: Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Lysholm Knee Scoring Scale Score
Time frame: Baseline, 6 months, 12 months, and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- 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.
Karlie Morgan, BS CCRP study chair
Smith & Nephew, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Tear and Retention; Meniscus, run by Smith & Nephew, Inc. at 6 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?
The sponsor lists 14 inclusion and 33 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: stopped early, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 24 Feb 2026). 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?
Rate of Freedom From Reoperation at 12 Months After Surgery (time frame: 12 months). 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 24 Feb 2026.