Open label trial of intramuscular pentosan polysulfate on acute traumatic knee injury

Phase 1

Terminated

• Conditions: Bone marrow oedema lesion associated with acute traumatic knee injury; Musculoskeletal - Other muscular and skeletal disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12616000009415
• Lead Sponsor: Paradigm BioPharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Subjects who have experienced an acute anterior cruciate ligament (ACL) injury a minimum of 1 week and maximum of 14 weeks prior to Day 0, and have been managed conservatively with physical therapy and medications
Subjects with bone marrow lesions of the femur or tibia on at least 2 consecutive sagittal or coronal MRI slices as confirmed by an independent reader.
OR
subjects who have experienced an acute anterior cruciate ligament (ACL) injury a minimum of 2 weeks maximum of 14 weeks prior to Day 0 and have been treated with surgical intervention to repair the acute injury within a minimum of 2 weeks and maximum of 14 weeks prior to Day 0.

Exclusion Criteria

1. Subjects who have been treated with surgical intervention for the ACL injury in the affected knee
2. Subjects in whom surgery for the ACL injury in the affected knee is planned during the study period
3. Osteonecrosis, osseous infection/inflammation or visible cartilage damage of the affected joint
4. Systemic arthritis or osteoarthritis (OA) in multiple other joints

Study & Design

• Study Type: Interventional
• Study Design: Not specified