Clinical trial NCT04088227: Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears
Official title: Effect of Platelet Rich Plasma Injections on Inflammatory and Chondrodegenerative Biomarkers in Patients With Acute Anterior Cruciate Ligament Tears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anterior Cruciate Ligament Tear
Anterior Cruciate Ligament Rupture
Lead sponsor: Andrews Research & Education Foundation
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 24
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A potential long-term consequence of anterior cruciate ligament injuries is the development of post-traumatic osteoarthritis in the years following injury. There are no curative treatments for osteoarthritis, increasing the importance of minimizing the occurrence of post-traumatic osteoarthritis following anterior cruciate ligament injuries. Current literature has begun to indicate that biochemical changes in the knee joint cartilage, such as chondrocyte death, following injury can contribute to the development of post-traumatic osteoarthritis.

The main objective of this study is to determine if an early intervention of joint aspiration and platelet rich plasma injection will positively affect the biomarkers representative of chondral degeneration in patients with anterior cruciate ligament injuries. We hypothesize that the intervention will reduce the volume of inflammatory and chondrodegenerative biomarkers following anterior cruciate ligament injury.

Detailed description: A non-surgical treatment option for the management of osteoarthritis include injectables such as corticosteroids and platelet rich plasma. These injectables work by positively affecting cartilage cells, also known as chondrocytes, and the cells of the joint lining tissue, also known as synoviocytes. Platelet rich plasma is an autologous derived blood product, i.e. a joint injectable made from the patient's own blood at the time and location of injection with simple blood centrifugation. Studies in the bench-top laboratory setting have provided in-vitro evidence that platelet rich plasma decreases synoviocyte production of metallometal proteases, an inflammatory protein with negative effects on cartilage and decreases the effects of inflammatory proteins.

Eligibility criteria: Inclusion Criteria:

* No history of previous traumatic ipsilateral knee injury
* Bone bruise visualized on MRI
* No clinical evidence of posterior cruciate ligament injury with no more than grade 1 medial or lateral collateral ligament injury

Exclusion Criteria:

* Patients without a palpable knee effusion
* An injury occurring more than 10 days before enrollment
* Previous ipsilateral knee surgery
* Intra-articular cortisone or platelet rich plasma injection into either knee within 3 months of injury
* Participation in another clinical drug trial within the 4 weeks before injury
* A history of any inflammatory disease or immune-comprised

Primary outcomes:
measure: Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
timeFrame: Timepoint 1: initial visit (within 10 days of injury) Timepoint 2: at the time of surgery (within 4 weeks of injury)
Secondary outcomes:
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: Andrews Institute for Orthopaedics & Sports Medicine
state: Florida
Study officials:
affiliation: Andrews Institute for Orthopaedics & Sports Medicine
name: Adam W Anz, MD
role: PRINCIPAL_INVESTIGATOR
References: