TerminatedPhase 2ACTRN12616000009415

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

A pilot study investigating the short-term outcome of intramuscular administration of pentosan polysulfate sodium for the treatment of bone marrow lesions of the knee

Sponsor

Paradigm BioPharmaceuticals Ltd

Enrollment

40 participants

Start Date

Feb 20, 2016

Study Type

Interventional

Conditions

Bone marrow oedema lesion associated with acute traumatic knee injury

Summary

The main aim of this study is to see whether pentosan polysulfate sodium (PPS) is safe and effective in treating Bone Marrow Oedema Lesion (BML) associated with acute knee injury and thereby relieving the pain caused by BML. Every person who participates in this study will receive a course of PPS injections.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria4

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 Criteria4

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

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Interventions

Single arm study -Twice weekly injections of pentosan polysulfate (PPS) for 3 weeks administered intra muscularly at a dose of 2 mg/kg. PPS will be administered at the study site by clinical staff.

Single arm study -Twice weekly injections of pentosan polysulfate (PPS) for 3 weeks administered intra muscularly at a dose of 2 mg/kg. PPS will be administered at the study site by clinical staff. No specific strategies to monitor adherence are required.

Locations(1)

Sportsmed SA Hospital - Stepney

SA,VIC, Australia

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ACTRN12616000009415