Trials / Withdrawn
WithdrawnNCT03562299
OrthoPure™ XT Pilot Clinical Study
A Prospective, Non-comparative Pilot Clinical Study of a Novel Xenograft Device for Reconstruction of the Anterior Cruciate Ligament.
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- TRX Orthopedics · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OrthoPure™ XT | A decellularized, sterile, single use, xenograft device for reconstruction of the anterior cruciate ligament |
Timeline
- Start date
- 2018-07-01
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2018-06-19
- Last updated
- 2018-11-21
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03562299. Inclusion in this directory is not an endorsement.