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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000009415

Enrollment

Registered

2016-01-12

Start date

2016-02-20

Completion date

2017-06-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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. No specific strategies to monitor adherence are required.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

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

Outcome results