ACL InjuryNCT06442319
The Efficiency and Safety of PRP Treatment After Anterior Cruciate Ligament Reconstruction.
A study testing Platelet-rich plasma in people with ACL Injury and Knee Osteoarthritis, run by Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz at 1 site in Poland.
Trial summary
The anterior cruciate ligament (ACL) is the main stabilizer of the knee joint, as it controls anteroposterior and rotatory knee laxity. The number of ACL injuries has increased in the past three decades because more and more people participate in recreational and competitive sporting activities. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- ACL Injury, Knee Osteoarthritis, Knee Injuries
- What is being tested?
- Platelet-rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2024to 15 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- subject is 18-45 years old
- subject has BMI < 40 kg/m2
- subject had ACL reconstrution
- small asymptomatic meniscal lesions that won't require repair
- subject must be willing to abstain from other intra-articular treatments of the knee for the duration of the study.
- subject is willing to discontinue all analgesics including nonsteroidal anti-inflammatory drugs (NSAIDs), except tramadol and paracetamol, at least one month before the synovial fluid aspiration and through the completion of the study
- subject is able to understand and comply with the requirements of the study and voluntarily provides consent
Who cannot join
- subject has a history of metabolic diseases, endocrine disorders, rheumatic and connective tissue diseases, cancer, hormonal contraception, steroid therapy, antibiotic therapy
- subject had an intraarticular injection into the affected joint
- subject had previous operations (beside ACL reconstruction) or fractures of the affected limb
- subject has a history of nicotine, alcohol, or drug addiction
- subject has a meniscal tear that requires suturing or total meniscectomy seen on MRI
- subject has multi-ligament knee injuries or multi-organ injury
- subject has significant varus or valgus deformity greater than 10 degrees in either knee, determined by an X-ray
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Dawid Szwedowski
Torun, 87-100
Dawid Szwedowski, MD, PhD, 608075237, dszwedow@yahoo.com
dszwedow@yahoo.com
About this study
Official title: The Efficiency and Safety of Platelet-rich Plasma Intra-articular Injections After Anterior Cruciate Ligament Reconstruction: MRI and Clinical Outcome Analysis.
The anterior cruciate ligament (ACL) is the main stabilizer of the knee joint, as it controls anteroposterior and rotatory knee laxity. The number of ACL injuries has increased in the past three decades because more and more people participate in recreational and competitive sporting activities. Injury to the ACL often leads to functional instability, damage to the meniscus and articular cartilage, and an increased risk for osteoarthritis (OA). Emphasizes the fact that ACL has limited healing potential 'The gold standard' treatment is ACL reconstruction, with over 200,000 reconstruction surgeries performed annually in the United States. However, despite the success of surgery in restoring functional stability, it has been found so far in several studies that the prevalence of moderate to severe arthritis in long-term radiographic follow-up is more than 50% after ACL reconstruction within 5 to 15 years or sooner. ACL-injured knees had at least 3 times higher risk of arthritis than uninjured contralateral knees. Early osteoarthritis was observed on magnetic resonance imaging (MRI) up to 11 years following ACL injury after operative and nonoperative management. Because ACL injuries predominantly occur in individuals between the ages of 15 and 25 years, symptoms of OA most often affect patients during their most productive years. This is worrisome because most patients who sustain ACL tears are free of the risk of other factors for developing OA.Consequently, posttraumatic OA after ACL reconstruction ultimately translates into a large economic effect on the healthcare system owing to the young age of this population. Platelet-rich plasma is an autologous solution of highly concentrated platelets dispersed in a small capacity of plasma. Enthusiasm for the therapeutic potential of platelets is based on its rich omplement of anabolic growth factors and anti-inflammatory cytokines in the platelets, which induce cellular proliferation, migration, differentiation, angiogenesis, and extracellular matrix synthesis. In addition, the functional mechanisms of PRP in OA treatment have been explained by its effect on modulating critical pro-inflammatory mediators and catabolic enzymes, as well as maintaining joint homeostasis. The reasons for this early incidence of post-traumatic OA remain unclear, but the underlying mechanisms have been speculated to involve some combination of cartilage damage at the time of injury, and posttraumatic molecular changes in the joint, including immune reactions or persistent secondary inflammation. We hypothesized that PRP injection after ACL reconstruction could prevent cartilage damage, act anti-inflammatory, and provide better clinical and radiological outcomes seen in MRI.
- Conditions
- ACL Injury, Knee Osteoarthritis, Knee Injuries
- Being tested
- Platelet-rich plasma
- Keywords
- PRP, ACL reconstruction, knee osteoarthritis
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Osteoarthritis, Knee, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasmaBiological
Platelet-rich plasma intra-articular injection in patients after anterior cruciate ligament reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich Plasma | Experimental | Not described Receives: Biological: Platelet-rich plasma |
| Hyaluronic Acid | Active comparator | Not described Receives: Biological: Platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and cartilage volume
The 2 primary outcomes were 12-month change in overall average knee pain scores (11-point scale; range, 0-10, with higher scores indicating worse pain; minimum clinically important difference of 1.8) and percentage change in cartilage volume as assessed by magnetic resonance imaging (MRI).
Measured: 12 months
Secondary outcomes (1)
Synovitis
The assesment of synovial fluid volume and fat pad synovitis seen in ultrasonography and MRI
Measured: 6 and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jun 2024 (estimated)
- Primary completion15 Apr 2028 (estimated)
- Study completion15 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442319
- Sponsor's protocol ID
- NicolausCopernicusU
- Status last verified
- May 2024
- First submitted
- 29 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lohmander LS, Ostenberg A, Englund M, Roos H. High prevalence of knee osteoarthritis, pain, and functional limitations in female soccer players twelve years after anterior cruciate ligament injury. Arthritis Rheum. 2004 Oct;50(10):3145-52. doi: 10.1002/art.20589.
PubMed 15476248Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.
PubMed 20660401
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency and Safety of Platelet-rich Plasma Intra-articular Injections After Anterior Cruciate Ligament Reconstruction: MRI and Clinical Outcome Analysis.
- ClinicalTrials.gov ID
- NCT06442319
- Acronym / sponsor ID
- NicolausCopernicusU
- Conditions
- ACL Injury, Knee Osteoarthritis, Knee Injuries
- Keywords
- PRP, ACL reconstruction, knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nicolaus Copernicus University in Toruń, Collegium Medicum in BydgoszczUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 15 Apr 2030 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The anterior cruciate ligament (ACL) is the main stabilizer of the knee joint, as it controls anteroposterior and rotatory knee laxity. The number of ACL injuries has increased in the past three decades because more and more people participate in recreational and competitive sporting activities. Injury to the ACL often leads to functional instability, damage to the meniscus and articular cartilage, and an increased risk for osteoarthritis (OA). Emphasizes the fact that ACL has limited healing potential 'The gold standard' treatment is ACL reconstruction, with over 200,000 reconstruction surgeries performed annually in the United States. However, despite the success of surgery in restoring functional stability, it has been found so far in several studies that the prevalence of moderate to severe arthritis in long-term radiographic follow-up is more than 50% after ACL reconstruction within 5 to 15 years or sooner. ACL-injured knees had at least 3 times higher risk of arthritis than uninjured contralateral knees. Early osteoarthritis was observed on magnetic resonance imaging (MRI) up to 11 years following ACL injury after operative and nonoperative management. Because ACL injuries predominantly occur in individuals between the ages of 15 and 25 years, symptoms of OA most often affect patients during their most productive years. This is worrisome because most patients who sustain ACL tears are free of the risk of other factors for developing OA.Consequently, posttraumatic OA after ACL reconstruction ultimately translates into a large economic effect on the healthcare system owing to the young age of this population. Platelet-rich plasma is an autologous solution of highly concentrated platelets dispersed in a small capacity of plasma. Enthusiasm for the therapeutic potential of platelets is based on its rich omplement of anabolic growth factors and anti-inflammatory cytokines in the platelets, which induce cellular proliferation, migration, differentiation, angiogenesis, and extracellular matrix synthesis. In addition, the functional mechanisms of PRP in OA treatment have been explained by its effect on modulating critical pro-inflammatory mediators and catabolic enzymes, as well as maintaining joint homeostasis. The reasons for this early incidence of post-traumatic OA remain unclear, but the underlying mechanisms have been speculated to involve some combination of cartilage damage at the time of injury, and posttraumatic molecular changes in the joint, including immune reactions or persistent secondary inflammation. We hypothesized that PRP injection after ACL reconstruction could prevent cartilage damage, act anti-inflammatory, and provide better clinical and radiological outcomes seen in MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich Plasma | Experimental | Biological: Platelet-rich plasma |
| Hyaluronic Acid | Active comparator | Biological: Platelet-rich plasma |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- subject is 18-45 years old
- subject has BMI < 40 kg/m2
- subject had ACL reconstrution
- small asymptomatic meniscal lesions that won't require repair
- subject must be willing to abstain from other intra-articular treatments of the knee for the duration of the study.
Key exclusion criteria (7 listed)
- subject has a history of metabolic diseases, endocrine disorders, rheumatic and connective tissue diseases, cancer, hormonal contraception, steroid therapy, antibiotic therapy
- subject had an intraarticular injection into the affected joint
- subject had previous operations (beside ACL reconstruction) or fractures of the affected limb
- subject has a history of nicotine, alcohol, or drug addiction
- subject has a meniscal tear that requires suturing or total meniscectomy seen on MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-rich plasmaPlatelet-rich plasma intra-articular injection in patients after anterior cruciate ligament reconstruction | Biological | Hyaluronic Acid, Platelet-rich Plasma |
Primary outcome
Pain and cartilage volume
Time frame: 12 months
The 2 primary outcomes were 12-month change in overall average knee pain scores (11-point scale; range, 0-10, with higher scores indicating worse pain; minimum clinically important difference of 1.8) and percentage change in cartilage volume as assessed by magnetic resonance imaging (MRI).
1 secondary outcome
Synovitis
Time frame: 6 and 12 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 15476248Lohmander LS, Ostenberg A, Englund M, Roos H. High prevalence of knee osteoarthritis, pain, and functional limitations in female soccer players twelve years after anterior cruciate ligament injury. Arthritis Rheum. 2004 Oct;50(10):3145-52. doi: 10.1002/art.20589.
- Background: PubMed 20660401Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.
- Individual participant dataSharing planned: No
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich plasma in people with ACL Injury and Knee Osteoarthritis, run by Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dawid Szwedowski, MD, PhD (608075237, dszwedow@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and cartilage volume (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06442319, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.