Health TrialsbyHealthPanel

PRP in ACLR to Prevent PTOA

ConditionsAnterior Cruciate Ligament InjuriesPost-traumatic OsteoarthritisPRP
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age14-50
SponsorHospital for Special Surgery, New York

About this trial

The purpose of our study is to examine the effect of platelet-rich-plasma (PRP) injection on the short-term resolution of post-injury inflammation (biomarkers) and improvement in joint function in patients with acute ACL injury. This RCT has been powered based on the questionnaire KOOS Jr. but it is considered a 'pilot study' in terms of the lab analysis proposed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute ACL injury within 6 weeks of presentation

Age 14-50

Male or female

Meniscus injury that can be treated with meniscectomy or repair (the lack of meniscus injury will not exclude patients)

Disqualifiers

Prior ACL reconstruction

Prior cartilage repair procedure

Prior meniscus surgery within 12 months

Prior steroid, hyaluronic acid, or PRP injection within 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • platelet rich plasma (PRP) injection

    Procedure/Surgery

    We aim to evaluate early catabolic and inflammatory changes in knee joints in patients receiving PRP injections following ACL injury, as these patients are at higher risk of developing PTOA. We also aim to establish correlations between markers of biologic activity of PRP and clinical outcomes (including both patient-reported outcomes and clinical functional outcomes), with emphasis on cellular and molecular inflammatory parameters modulated by PRP.

  • placebo saline injection

    Procedure/Surgery

    Patients randomized into the control arm will receive the placebo or saline injection

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Control ArmPlacebo comparator 1 intervention
Group B: Investigational ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Platelet count (Thousand/uL)

Platelet count (Thousand/uL) will be measured by completing a complete blood count on patient's blood sample.

Time frame
Baseline
2

Platelet count (Thousand/uL)

Platelet count (Thousand/uL) will be measured by completing a complete blood count on patient's blood sample.

Time frame
during the procedure
3

Knee Injury and Osteoarthritis Outcome (KOOS-JR)

This survey asks about how the patient feels about their knee. The information helps keep track of how the patient feels about their knee and how well they are able to do their usual activities. There is no unique measurements. Answer options per question regarding stiffness, pain, function, daily and living are: None, Mild, Moderate, Severe, and Extreme

Time frame
Baseline
4

Knee Injury and Osteoarthritis Outcome (KOOS-JR)

This survey asks about how the patient feels about their knee. The information helps keep track of how the patient feels about their knee and how well they are able to do their usual activities. There is no unique measurements. Answer options per question regarding stiffness, pain, function, daily and living are: None, Mild, Moderate, Severe, and Extreme

Time frame
during the procedure

Secondary outcomes

1

Knee stability

Using the KT1000 arthrometer

Time frame
6 months post-surgery
2

Knee stability

Using the KT1000 arthrometer

Time frame
12 months post-surgery
3

Knee stability

Using the KT1000 arthrometer

Time frame
24 months post-surgery
4

Knee strength

Using the Cybex test

Time frame
6 months post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital for Special Surgery, New York

Lead sponsor

Orthopedic Research and Education Foundation

Collaborator

Source ClinicalTrials.gov
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