Effectiveness of Autologous Platelet-rich Plasma on Knee Cartilage Injury
Primary Purpose
Cartilage Injury
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
autologous platelet-rich plasma
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Cartilage Injury
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
autologous platelet-rich plasma group
normal saline group
Arm Description
The patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group.
The patients with knee cartilage injury were randomized to the normal saline group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
2000 IKDC Subjective Knee Evaluation Form score
To used for assessing functional recovery of the knee joint. Higher scores indicate better recovery.
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.
Full Information
NCT ID
NCT03024801
First Posted
January 17, 2017
Last Updated
January 18, 2017
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03024801
Brief Title
Effectiveness of Autologous Platelet-rich Plasma on Knee Cartilage Injury
Official Title
Effectiveness of Autologous Platelet-rich Plasma on Knee Cartilage Injury: a Randomized, Controlled, Open-label Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cartilage Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
autologous platelet-rich plasma group
Arm Type
Experimental
Arm Description
The patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group.
Arm Title
normal saline group
Arm Type
Experimental
Arm Description
The patients with knee cartilage injury were randomized to the normal saline group.
Intervention Type
Drug
Intervention Name(s)
autologous platelet-rich plasma
Intervention Description
The patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group.
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
The patients with knee cartilage injury were randomized to the normal saline group.
Primary Outcome Measure Information:
Title
Lysholm score
Description
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.
Time Frame
at 3 months after final injection
Secondary Outcome Measure Information:
Title
2000 IKDC Subjective Knee Evaluation Form score
Description
To used for assessing functional recovery of the knee joint. Higher scores indicate better recovery.
Time Frame
at 3 months after final injection
Title
Numerical rating scale score
Description
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.
Time Frame
changes of month 1, month 2 and month 3 after initial injection, and month 3 after final injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quanyi Guo, Ph.D
Organizational Affiliation
Chinese PLA Hospital, China
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effectiveness of Autologous Platelet-rich Plasma on Knee Cartilage Injury
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