OrthoPure™ XT Pilot Clinical Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Knee Injuries; Anterior Cruciate Ligament (ACL) Reconstruction
• Intervention / Treatment: Device: OrthoPure™ XT

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St.Joseph's Outpatient Surgery Center
  • Indiana
    • Greenwood, Indiana, United States, 46143
      • OrthoIndy Hospital South
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients who are skeletally mature, as evidenced by closed tibial and femoral epiphyses on x-rays at baseline.
2. 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.
3. 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.
4. Patients who have Medial Collateral Ligament (MCL) injury of Grade 2 or less.
5. Patients with osteoarthritis of Grade 2 or less as defined radiographically on the Kellgren-Lawrence (K-L) scale.
6. Patients who are able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study.
7. Patients who are willing and able to comply with all study procedures including all pre-operative, post-operative and rehabilitation requirements.
8. 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.

Exclusion Criteria:

1. Patients with Body Mass Index (BMI) greater than 35 kg/m2.
2. 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.
3. Patients who have had previous ACL reconstruction on the target knee.
4. Patients who have had any other type of surgical procedure on the target knee in the 3 months prior to Visit 1.
5. Patients with ligament instability, osteoarthritis greater than Grade 2 or a current ACL injury in the contralateral knee.
6. Patients with a complete or partial Lateral Collateral Ligament (LCL) tear or Posterior Cruciate Ligament (PCL) tear on the target knee.
7. 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.
8. 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.
9. 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.
10. Patients who have previously been implanted with any type of xenograft device.
11. 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.
12. Patients who have conditions that may be exacerbated by, or may interfere with the results of the skin prick test.
13. 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.).
14. Patients with active neoplastic disease.
15. Patients with known allergy to mammalian meat, porcine products or a religious objection to the use of implanted porcine material.
16. Patients with current drug or alcohol abuse, or a history of the same within the last 6 months.
17. Patients with local circulatory problems, (e.g. thrombophlebitis and lymphedema).
18. Patients with any mental or psychological disorder that would impair their ability to complete the study questionnaires.
19. 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.

20. Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; A decellularized, sterile, single use, xenograft device for reconstruction of the anterior cruciate ligament

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in knee stability - Pivot Shift Test	Measured by the assessment of change in the anterior cruciate instability in the treated knee	3, 6, 12 and 24 months
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	3, 6, 12 and 24 months
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	3, 6, 12 and 24 months
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	3, 6, 12 and 24 months
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	6,12 and 24 months
Evidence of integration of the investigational product	MRI assessments	3, 6, 12 and 24 months
Improvement in quality of life	A questionnaire on the self-assessment of health condition reflecting the physical condition and mental health	3, 6, 12 and 24 months
Assessment of investigational device usability	Surgeon assessment of the device (questionnaire), rate from excellent to poor	Day 0
Assessment on Bone Tunnel Position	To be assessed via X Ray	2 weeks, 6 Months

Collaborators and Investigators

• Sponsor: TRX Orthopedics
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: TRG-A02/0021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes