OrthoPure™ XT Pilot Clinical Study

NCT03562299 | Withdrawn FDA Device

• 1 other identifier: TRG-A02/0021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Knee Injuries; Anterior Cruciate Ligament (ACL) Reconstruction

Outcome Measures

Primary Outcomes (4)

• Assessment of anti-Gal IgG antibody levels

  Blood sample collection for measurement of immune response

  profile up to 24 months

• Measurement of serum chemistry

  Blood sample analysis

  up to 24 months

• Incidence of secondary surgical interventions (SSIs)

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

  up to 24 months

• Incidence of individual Adverse Events

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

  up to 24 months

Secondary Outcomes (9)

• Improvement in knee stability - Pivot Shift Test

  3, 6, 12 and 24 months

• Improvement in knee stability - Lachman test

  3, 6, 12 and 24 months

• Improvement in knee stability - Anterior Drawer Test

  3, 6, 12 and 24 months

• Arthrometric measurement of knee joint laxity

  3, 6, 12 and 24 months

• Improvement in pain and function of the knee measured by questionnaires

  6,12 and 24 months

Study Arms (1)

Experimental

EXPERIMENTAL

Reconstruction of the Anterior Cruciate Ligament (ACL) using OrthoPure™ XT in patients with a partial or complete tear of the Anterior Cruciate Ligament (ACL)

Device: OrthoPure™ XT

Interventions

OrthoPure™ XT DEVICE

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

Experimental

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• TRX Orthopedics: lead

Study Sites (3)

St.Joseph's Outpatient Surgery Center

Phoenix, Arizona, 85013, United States

Location

OrthoIndy Hospital South

Greenwood, Indiana, 46143, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Tom Carter

  St. Joseph's Outpatient Surgery Center

  PRINCIPAL INVESTIGATOR

• Jack Farr

  OrthoIndy Hospital South

  PRINCIPAL INVESTIGATOR

• David Caborn

  Jewish Hospital and St. Mary's Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 19, 2018
• Study Start: July 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 21, 2018

Record last verified: 2018-11

Locations

US (3)