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Knee InjuriesNCT03562299

OrthoPure™ XT Pilot Clinical Study

A study testing OrthoPure™ XT in people with Knee Injuries and Anterior Cruciate Ligament (ACL) Reconstruction, run by TRX Orthopedics at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To evaluate the clinical safety and obtain preliminary effectiveness data for OrthoPure™ XT device in a small group of US patients at 12 and 24 months. The clinical experience obtained from this study will be used to develop a pivotal study for follow up in a larger patient population. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
OrthoPure™ XT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
Jul 2018to Dec 2020
Phase
Interventional
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients who are skeletally mature, as evidenced by closed tibial and femoral epiphyses on x-rays at baseline.
  • Patients who have been diagnosed with a partial or complete tear of the ACL as determined by MRI, require surgical reconstruction of the ACL, and are candidates for ACL surgery.
  • Patients who have passive flexion ≥ 120°, and passive extension on the target knee is the same as the contralateral knee, in the judgment of the Investigator.
  • Patients who have Medial Collateral Ligament (MCL) injury of Grade 2 or less.
  • Patients with osteoarthritis of Grade 2 or less as defined radiographically on the Kellgren-Lawrence (K-L) scale.
  • Patients who are able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study.
  • Patients who are willing and able to comply with all study procedures including all pre-operative, post-operative and rehabilitation requirements.
  • If female and of child-bearing potential, patients who have a negative urine pregnancy test at Visit 2 and have no intention to become pregnant in the next 24 months.

Who cannot join

  • Patients with Body Mass Index (BMI) greater than 35 kg/m2.
  • Patients presenting with osteoarthritis of the target knee e.g. International Cartilage Repair Society (ICRS) Grade III or higher as determined by their baseline MRI scan.
  • Patients who have had previous ACL reconstruction on the target knee.
  • Patients who have had any other type of surgical procedure on the target knee in the 3 months prior to Visit 1.
  • Patients with ligament instability, osteoarthritis greater than Grade 2 or a current ACL injury in the contralateral knee.
  • Patients with a complete or partial Lateral Collateral Ligament (LCL) tear or Posterior Cruciate Ligament (PCL) tear on the target knee.
Show all 21Show fewer
  • Patients with meniscal repairs and tears requiring more than one third (1/3) removal of the meniscus on the target knee as determined during knee arthroscopy.
  • Patients who have an active systemic infection, or an active local infection in or near the target knee, or have a previous history of joint infection.
  • Patients who are participating concurrently in another clinical trial, or have participated in a clinical trial within the last 90 days, or intend to during the course of the study.
  • Patients who have previously been implanted with any type of xenograft device.
  • Patients with known immunodeficiency including patients who are receiving or have received corticosteroids, immunosuppressants, immunostimulating agents or radiation therapy within 6 months of Visit 1.
  • Patients who have conditions that may be exacerbated by, or may interfere with the results of the skin prick test.
  • Patients with significant comorbidities or conditions associated with high risk for surgical or anesthetic survival (e.g. renal failure, peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.).
  • Patients with active neoplastic disease.
  • Patients with known allergy to mammalian meat, porcine products or a religious objection to the use of implanted porcine material.
  • Patients with current drug or alcohol abuse, or a history of the same within the last 6 months.
  • Patients with local circulatory problems, (e.g. thrombophlebitis and lymphedema).
  • Patients with any mental or psychological disorder that would impair their ability to complete the study questionnaires.
  • Patients with any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the patient unable to perform appropriate postoperative rehabilitation.
  • Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
  • -

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • OrthoIndy Hospital South

    Greenwood, Indiana, 46143

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • St.Joseph's Outpatient Surgery Center

    Phoenix, Arizona, 85013

Other trials in United States

About this study

Official title: A Prospective, Non-comparative Pilot Clinical Study of a Novel Xenograft Device for Reconstruction of the Anterior Cruciate Ligament.

To evaluate the clinical safety and obtain preliminary effectiveness data for OrthoPure™ XT device in a small group of US patients at 12 and 24 months. The clinical experience obtained from this study will be used to develop a pivotal study for follow up in a larger patient population.

Read the detailed description

The OrthoPure™ XT device is a decellularized, sterile, single use biological scaffold for use in the treatment of patients with a partial or complete tear of the Anterior Cruciate Ligament (ACL) who require surgical reconstruction of the ACL.

This is a Pilot Safety Study. The primary objective of this study is to evaluate the clinical safety of the OrthoPure™ XT device in a small group of patients that require reconstruction of the Anterior Cruciate Ligament (ACL) due to partial or complete tear of the ACL.

Clinical safety will be analyzed through measurement of immune response (alpha-Gal IgG), blood and urine analysis, incidence of secondary surgical interventions with the treated knee, and the incidence of individual adverse events.

The second objectives of this study are to assess the efficacy endpoints, specifically: improvement in knee stability, function and pain; improvement in patient quality of life and radiographic analysis.

Being tested
OrthoPure™ XT
Medical subject headings
Knee Injuries

What participants receive

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

  • OrthoPure™ XTDevice

    A decellularized, sterile, single use, xenograft device for reconstruction of the anterior cruciate ligament

Study groups in NCT03562299
Study groupRoleWhat they receive
ExperimentalExperimentalReconstruction of the Anterior Cruciate Ligament (ACL) using OrthoPure™ XT in patients with a partial or complete tear of the Anterior Cruciate Ligament (ACL)
Receives: Device: OrthoPure™ XT

What is being measured

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

  1. Assessment of anti-Gal IgG antibody levels

    Blood sample collection for measurement of immune response

    Measured: profile up to 24 months

  2. Measurement of serum chemistry

    Blood sample analysis

    Measured: up to 24 months

  3. Incidence of secondary surgical interventions (SSIs)

    The frequency and seriousness of any secondary surgical interventions will be assessed.

    Measured: up to 24 months

  4. Incidence of individual Adverse Events

    The frequency and seriousness of any adverse events or adverse device.effects will be assessed.

    Measured: up to 24 months

Secondary outcomes (9)

  1. Improvement in knee stability - Pivot Shift Test

    Measured by the assessment of change in the anterior cruciate instability in the treated knee

    Measured: 3, 6, 12 and 24 months

  2. Improvement in knee stability - Lachman test

    Measured by clinical examination of the treated knee (assessment of anterior translation), more than about 2 mm of anterior translation compared to the normal opposite knee suggests an ACL tear

    Measured: 3, 6, 12 and 24 months

  3. Improvement in knee stability - Anterior Drawer Test

    Clinical assessment of the treated knee, an increased amount of anterior tibial translation compared with the opposite, normal knee can indicate an ACL tear. If the tibia pulls forward or backward more than normal, the test is considered positive

    Measured: 3, 6, 12 and 24 months

  4. Arthrometric measurement of knee joint laxity

    Comparison of the side-to-side differences in mm between the treated knee and the opposite normal knee using an arthrometric ligament testing device

    Measured: 3, 6, 12 and 24 months

  5. Improvement in pain and function of the knee measured by questionnaires

    Patient's subjective score of 1 to 100 points, with 100 implying the best results and 1 the worse results

    Measured: 6,12 and 24 months

  6. Evidence of integration of the investigational product

    MRI assessments

    Measured: 3, 6, 12 and 24 months

  7. Improvement in quality of life

    A questionnaire on the self-assessment of health condition reflecting the physical condition and mental health

    Measured: 3, 6, 12 and 24 months

  8. Assessment of investigational device usability

    Surgeon assessment of the device (questionnaire), rate from excellent to poor

    Measured: Day 0

  9. Assessment on Bone Tunnel Position

    To be assessed via X Ray

    Measured: 2 weeks, 6 Months

Timeline

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

  1. First posted19 Jun 2018
  2. Study startJul 2018 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Why it stopped: Unspecified business decision/strategic reason.

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03562299
Sponsor's protocol ID
TRG-A02/0021
Status last verified
Nov 2018
First submitted
18 May 2018
Last updated
21 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing OrthoPure™ XT in people with Knee Injuries and Anterior Cruciate Ligament (ACL) Reconstruction, run by TRX Orthopedics at 3 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 8 inclusion and 21 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: withdrawn, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Assessment of anti-Gal IgG antibody levels (time frame: profile up to 24 months). The study lists 4 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 NCT03562299.

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 21 Nov 2018.

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