Cartilage InjuryNCT03024801
Effectiveness of Autologous Platelet-rich Plasma on Knee Cartilage Injury
A study testing autologous platelet-rich plasma and normal saline in people with Cartilage Injury, run by Chinese PLA General Hospital.
Trial summary
To analyze the effectiveness of intra-articular injection of autologous PRP on knee cartilage repair and evaluating functional recovery of the knee joint in knee cartilage injury patients. Read more about this study
- Who is it for?
- Ages 14 to 55 years
- Conditions the study is for
- Cartilage Injury
- What is being tested?
- autologous platelet-rich plasma and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Knee cartilage injury
- Having normal and stable joint motion but no deformity
- Focal cartilage defects confirmed by magnetic resonance imaging (MRI), Outerbridge classification III/IV with a defect size < 10 cm2 graded as Outerbridge II at maximum
- Focal articular cartilage injury in the knee
- 14-55 years of age
- Provision of signed informed consent to participate in the trial
Who cannot join
- Poor general condition
- Blood diseases
- Use of local hormone treatment within 3 months before the trial
- Bleeding tendency
- Drug addiction, including anesthetic, alcohol and poison
- Inflammatory arthropathy, including specific and non-specific arthritis and severe osteoarthritis
Show all 10Show fewer
- Contagious viral infection
- Metabolic diseases, such as gout and rheumatism
- Pregnant or lactating, or planning to become pregnant within 1 year after the initial registration
- Unable to cooperate with rehabilitation therapy because of psychological/mental disorders
About this study
Official title: Effectiveness of Autologous Platelet-rich Plasma on Knee Cartilage Injury: a Randomized, Controlled, Open-label Clinical Trial
To analyze the effectiveness of intra-articular injection of autologous PRP on knee cartilage repair and evaluating functional recovery of the knee joint in knee cartilage injury patients.
Read the detailed description
Recent studies have shown that platelets, which contain a large number of cytokines and growth factors, can be beneficial in inflammatory response and postoperative bleeding, infection, bone formation, injury, muscle strain, and soft tissue healing. Platelets release a plethora of biologically active proteins to aggregate macrophages, mesenchymal stem cells (MSCs) and osteoblasts, thereby promoting degradation and clearing necrotic tissue, thus further activating wound healing. In fact, platelet-rich plasma (PRP) is now used clinically to promote cartilage repair.
By retrieving the Web of Science, a study by Havva et al. reported the clinical use of autologous PRP in 82 patients with advanced knee osteoarthritis with good outcomes. However, the clinical applications of this treatment have not been adequately investigated in randomized controlled trials. Given this, additional studies on the exact efficacy of this treatment are indispensible.
Three similar trial protocols to the current trial include 'Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma (NCT02365142)', 'PRP vs HA Intra-articular Knee Injections for Cartilage Defects (NCT02012530)', and 'Mesenchymal Stem Cells Enhanced With PRP Versus PRP In OA Knee (MSCPRPOAK) (NCT01985633)'. In these trial protocols, knee injury extent and treatment success were assessed by Osteoarthritis Score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) score as outcome measures. However, there are several differences in the inclusion criteria and randomization of these trials in comparison with the current trial protocol.
Since autologous PRP predominantly functions to relieve pain and inhibit inflammatory responses, clinical injection of autologous PRP for cartilage injury can stimulate chondrocyte growth and matrix metabolism. Existing evidence has shown that autologous PRP can increase type II collagen production and reduce apoptosis in chondrocytes when combined with autologous bone marrow-MSCs. Furthermore, PRP can improve cartilage degeneration and inhibit the development of osteoarthritis (OA) when combined with hydrogel microspheres. Accordingly, the clinical use of autologous PRP can alleviate the symptoms of OA, promote recovery of motor function, and ultimately improve patient quality of life.
To date, the clinical use of low-dose autologous PRP has been reported to alleviate pain at the injury site in the treatment of articular cartilage injury, and achieve cartilage repair and proliferation by releasing growth factors that promote extracellular matrix synthesis and vascular reconstruction. However, the clinical applications of autologous PRP have not been systemically reported in randomized controlled clinical trials, leading to a lack of objective evidence on its effectiveness.
- Conditions
- Cartilage Injury
- Being tested
- autologous platelet-rich plasma, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous platelet-rich plasmaDrug
The patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group.
normal salineDrug
The patients with knee cartilage injury were randomized to the normal saline group.
| Study group | Role | What they receive |
|---|---|---|
| autologous platelet-rich plasma group | Experimental | The patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group. Receives: Drug: autologous platelet-rich plasma |
| normal saline group | Experimental | The patients with knee cartilage injury were randomized to the normal saline group. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm score
To assess functional recovery of the knee joint. Lysholm score ranges from 0-100 with higher scores indicating better knee joint function. A score <70 indicates damage to the knee joint function.
Measured: at 3 months after final injection
Secondary outcomes (2)
2000 IKDC Subjective Knee Evaluation Form score
To used for assessing functional recovery of the knee joint. Higher scores indicate better recovery.
Measured: at 3 months after final injection
Numerical rating scale score
To assess pain relief of the knee joint. The numerical rating scale score ranges from 0-10, with a score of 0 indicating no pain and 10 indicating intense pain.
Measured: changes of month 1, month 2 and month 3 after initial injection, and month 3 after final injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startFeb 2012
- Primary completionMay 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage InjuryStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quanyi Guo, Chinese PLA General Hospital
- Investigators
- Quanyi Guo, Ph.D, Principal investigator, Chinese PLA Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024801
- Sponsor's protocol ID
- ChinaPLAGH_003
- Status last verified
- Jan 2017
- First submitted
- 17 Jan 2017
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Autologous Platelet-rich Plasma on Knee Cartilage Injury: a Randomized, Controlled, Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT03024801
- Acronym / sponsor ID
- ChinaPLAGH_003
- Conditions
- Cartilage Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Jan 2017 (estimated)
- 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.
To analyze the effectiveness of intra-articular injection of autologous PRP on knee cartilage repair and evaluating functional recovery of the knee joint in knee cartilage injury patients.
Detailed description
Recent studies have shown that platelets, which contain a large number of cytokines and growth factors, can be beneficial in inflammatory response and postoperative bleeding, infection, bone formation, injury, muscle strain, and soft tissue healing. Platelets release a plethora of biologically active proteins to aggregate macrophages, mesenchymal stem cells (MSCs) and osteoblasts, thereby promoting degradation and clearing necrotic tissue, thus further activating wound healing. In fact, platelet-rich plasma (PRP) is now used clinically to promote cartilage repair.
By retrieving the Web of Science, a study by Havva et al. reported the clinical use of autologous PRP in 82 patients with advanced knee osteoarthritis with good outcomes. However, the clinical applications of this treatment have not been adequately investigated in randomized controlled trials. Given this, additional studies on the exact efficacy of this treatment are indispensible.
Three similar trial protocols to the current trial include 'Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma (NCT02365142)', 'PRP vs HA Intra-articular Knee Injections for Cartilage Defects (NCT02012530)', and 'Mesenchymal Stem Cells Enhanced With PRP Versus PRP In OA Knee (MSCPRPOAK) (NCT01985633)'. In these trial protocols, knee injury extent and treatment success were assessed by Osteoarthritis Score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) score as outcome measures. However, there are several differences in the inclusion criteria and randomization of these trials in comparison with the current trial protocol.
Since autologous PRP predominantly functions to relieve pain and inhibit inflammatory responses, clinical injection of autologous PRP for cartilage injury can stimulate chondrocyte growth and matrix metabolism. Existing evidence has shown that autologous PRP can increase type II collagen production and reduce apoptosis in chondrocytes when combined with autologous bone marrow-MSCs. Furthermore, PRP can improve cartilage degeneration and inhibit the development of osteoarthritis (OA) when combined with hydrogel microspheres. Accordingly, the clinical use of autologous PRP can alleviate the symptoms of OA, promote recovery of motor function, and ultimately improve patient quality of life.
To date, the clinical use of low-dose autologous PRP has been reported to alleviate pain at the injury site in the treatment of articular cartilage injury, and achieve cartilage repair and proliferation by releasing growth factors that promote extracellular matrix synthesis and vascular reconstruction. However, the clinical applications of autologous PRP have not been systemically reported in randomized controlled clinical trials, leading to a lack of objective evidence on its effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autologous platelet-rich plasma group | Experimental | Drug: autologous platelet-rich plasmaThe patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group. |
| normal saline group | Experimental | Drug: normal salineThe patients with knee cartilage injury were randomized to the normal saline group. |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Knee cartilage injury
- Having normal and stable joint motion but no deformity
- Focal cartilage defects confirmed by magnetic resonance imaging (MRI), Outerbridge classification III/IV with a defect size < 10 cm2 graded as Outerbridge II at maximum
- Focal articular cartilage injury in the knee
- 14-55 years of age
Key exclusion criteria (10 listed)
- Poor general condition
- Blood diseases
- Use of local hormone treatment within 3 months before the trial
- Bleeding tendency
- Drug addiction, including anesthetic, alcohol and poison
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 |
|---|---|---|
| autologous platelet-rich plasmaThe patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group. | Drug | autologous platelet-rich plasma group |
| normal salineThe patients with knee cartilage injury were randomized to the normal saline group. | Drug | normal saline group |
Primary outcome
Lysholm score
Time frame: at 3 months after final injection
To assess functional recovery of the knee joint. Lysholm score ranges from 0-100 with higher scores indicating better knee joint function. A score <70 indicates damage to the knee joint function.
2 secondary outcomes
2000 IKDC Subjective Knee Evaluation Form score
Time frame: at 3 months after final injection
Numerical rating scale score
Time frame: changes of month 1, month 2 and month 3 after initial injection, and month 3 after final injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Quanyi Guo, Ph.D principal investigator
Chinese PLA Hospital, China
Questions about this trial
What is this clinical trial studying?
A study testing autologous platelet-rich plasma and normal saline in people with Cartilage Injury, run by Chinese PLA General Hospital.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm score (time frame: at 3 months after final injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2017.