Anterior Cruciate Ligament ReconstructionNCT05191732
Effect of PRP Versus BMC in Anterior Cruciate Ligament Reconstruction
A study testing Platelet-Rich Plasma; Bone marrow concentrate in people with Anterior Cruciate Ligament Reconstruction, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Anterior cruciate ligament (ACL) is an important stabilizer of knee during daily activity and exercise. The ruptured ACL need to be reconstructed by a new tendon graft which passed the bone tunnel and joint during operation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Platelet-Rich Plasma; Bone marrow concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Aug 2018to 4 Jul 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≧ 20 year-old
- the patient has been confirmed ACL rupture and the reconstruction is indicated
- sign IRB and operation consent
Who cannot join
- combined other ligament or extremities injury
- prior the same knee surgery
- open wound or operation history at knee joint
- Severe knee osteoarthritis
- history of multiple joint arthritis or rheumatoid arthritis
- Systemic diseases (infections, malignancies, immunodepression)
Show all 9Show fewer
- patients with bleeding tendency, anticoagulant or antiaggregant therapies
- patients with Hb values < 11 g/dl and/or platelet values < 150,000/mm
- refuse to sign Informed Consent Form and operation consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
About this study
Official title: The Therapeutic Effect of Autologous Platelet-Rich Plasma Versus Bone Marrow Concentrate in Anterior Cruciate Ligament Reconstruction - A Prospective, Double-Blind Randomized Controlled Study
Anterior cruciate ligament (ACL) is an important stabilizer of knee during daily activity and exercise. The ruptured ACL need to be reconstructed by a new tendon graft which passed the bone tunnel and joint during operation. How to enhance the tendon graft to bone tunnel healing is critical important to prevent recurrent ligament laxity, avoid secondary osteoarthritis, and achieve early return to sports and work.
Platelet Rich Plasma (PRP)，harvest from peripheral blood, is rich in multiple growth factors(i.e. VEGF, PDGD, TGFB, IGF, EGF) which help the injured tissue regeneration. Bone marrow stem cell has been demonstrated to enhance the injured tissue repair both in vitro and in vivo study.
Read more
However, there is no prospective study in comparing the PRP and BMC to enhance interfacial healing between graft and bone tunnel in ACL reconstruction. Investigators hypothesize that the combination of PRP and BMC has synergetic effect in interfacial healing in ACL reconstruction.
Aim of this study： To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.
Read the detailed description
Anterior cruciate ligament (ACL) is an important stabilizer of knee during daily activity and exercise. According to literature, there are 100,000- 200,000 ACL tear case annually in US. The patients with ACL tear will sustain with joint pain, muscle weakness, giving way sensation, other knee ligaments or meniscus injury, and consequent osteoarthritis change. However, the ruptured ACL cannot heal by itself due to limited vascularity supply, intraarticular inflammatory factors which inhibit the ACL cells migration and proliferation. The ruptured ACL need to be reconstructed by a new tendon graft which passed the bone tunnel and joint during operation. How to enhance the tendon graft to bone tunnel healing is critical important to prevent recurrent ligament laxity, avoid secondary osteoarthritis, and achieve early return to sports and work.
Platelet Rich Plasma (PRP)，harvest from peripheral blood, is rich in multiple growth factors(i.e. VEGF, PDGD, TGFB, IGF, EGF) which help the injured tissue regeneration. The PRP has been applied in treating tendinitis, osteoarthritis, cartilage injury, and bone nonunion. Bone marrow contains lots of stem cell and progenitor cells with capability of self-renewal and multi-differentiation. Bone marrow stem cell has been demonstrated to enhance the injured tissue repair both in vitro and in vivo study. The bone marrow concentrate (BMC) can be isolated from the bone marrow through the centrifuge procedure at one time which contains multiple stem cells. The bone marrow can regenerate itself around 1 week.
In recent years, many authors uses the combination of RPP and BMC to treat injured tissue. However, there is no prospective study in comparing the PRP and BMC to enhance interfacial healing between graft and bone tunnel in ACL reconstruction. Investigators hypothesize that the combination of PRP and BMC has synergetic effect in interfacial healing in ACL reconstruction.
The purpose of this study is to investigate the clinical outcome of autologous PRP, and combined BMC+PRP in tendon graft augmentation in the ACL reconstruction surgery with functional score and MRI evaluation. Investigators will analyze the therapeutic effect using one-way ANOVA. To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.
- Being tested
- Platelet-Rich Plasma; Bone marrow concentrate
- Keywords
- Anterior cruciate ligament reconstruction, Platelet-Rich Plasma, Bone marrow concentrate, Hamstring tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma; Bone marrow concentrateCombination product
Platelet-rich plasma (PRP) (Dosage form: APA-15) Bone marrow concentrate (BMC) (Dosage form: APA-15Q)
| Study group | Role | What they receive |
|---|---|---|
| PRP augmentation ACL reconstruction group | Experimental | Platelet-rich plasma (PRP) (Dosage form: APA-15) Receives: Combination Product: Platelet-Rich Plasma; Bone marrow concentrate |
| PRP+BMC augmentation ACL reconstruction group | Experimental | Bone marrow concentrate (BMC) (Dosage form: APA-15Q) Receives: Combination Product: Platelet-Rich Plasma; Bone marrow concentrate |
| Traditional ACL reconstruction group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
X-ray
X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.
Measured: preoperative
X-ray
X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.
Measured: 3 months after ACL reconstruction.
X-ray
X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.
Measured: 6 months after ACL reconstruction.
X-ray
X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.
Measured: 12 months after ACL reconstruction.
MRI
MRI to evaluate the joint space, graft to bone healing status and graft incorporation.
Measured: preoperative
MRI of operated knee
MRI to evaluate the joint space, graft to bone healing status and graft incorporation.
Measured: 3 months after ACL reconstruction.
MRI of operated knee
MRI to evaluate the joint space, graft to bone healing status and graft incorporation.
Measured: 6 months after ACL reconstruction.
MRI of operated knee
MRI to evaluate the joint space, graft to bone healing status and graft incorporation.
Measured: 12 months after ACL reconstruction.
Lysholm score
Lysholm score to evaluate the knee function recovery
Measured: preoperative
Lysholm score
Lysholm score to evaluate the knee function recovery
Measured: 3 months after ACL reconstruction.
Lysholm score
Lysholm score to evaluate the knee function recovery
Measured: 6 months after ACL reconstruction.
Lysholm score
Lysholm score to evaluate the knee function recovery
Measured: 12 months after ACL reconstruction.
IKDC 2000
IKDC 2000 to evaluate the knee function recovery
Measured: preoperative
IKDC 2000
IKDC 2000 to evaluate the knee function recovery
Measured: 3 months after ACL reconstruction.
IKDC 2000
IKDC 2000 to evaluate the knee function recovery
Measured: 6 months after ACL reconstruction.
IKDC 2000
IKDC 2000 to evaluate the knee function recovery
Measured: 12 months after ACL reconstruction.
Muscle power (N.m/kg)
muscle power test by Biodex System 3 Pro
Measured: preoperative
Muscle power (N.m/kg)
muscle power test by Biodex System 3 Pro
Measured: 3 months after ACL reconstruction.
Muscle power (N.m/kg)
muscle power test by Biodex System 3 Pro
Measured: 6 months after ACL reconstruction.
Muscle power (N.m/kg)
muscle power test by Biodex System 3 Pro
Measured: 12 months after ACL reconstruction.
Proprioception (degree)
Proprioception test by Biodex System 3 Pro
Measured: preoperative
Proprioception (degree)
Proprioception test by Biodex System 3 Pro
Measured: 3 months after ACL reconstruction.
Proprioception (degree)
Proprioception test by Biodex System 3 Pro
Measured: 6 months after ACL reconstruction.
Proprioception (degree)
Proprioception test by Biodex System 3 Pro
Measured: 12 months after ACL reconstruction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start3 Aug 2018
- Primary completion4 Jul 2020
- Study completion4 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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
- Model description
- To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
- Investigators
- Pei-Hsi Chou, PhD, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191732
- Sponsor's protocol ID
- KMUHIRB-F(I)-20170122
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Autologous Platelet-Rich Plasma Versus Bone Marrow Concentrate in Anterior Cruciate Ligament Reconstruction - A Prospective, Double-Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05191732
- Acronym / sponsor ID
- KMUHIRB-F(I)-20170122
- Keywords
- Anterior cruciate ligament reconstruction, Platelet-Rich Plasma, Bone marrow concentrate, Hamstring tendon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 4 Jul 2020 (actual)
- Study completion
- 4 Jul 2020 (actual)
- First posted
- 13 Jan 2022 (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.
Anterior cruciate ligament (ACL) is an important stabilizer of knee during daily activity and exercise. The ruptured ACL need to be reconstructed by a new tendon graft which passed the bone tunnel and joint during operation. How to enhance the tendon graft to bone tunnel healing is critical important to prevent recurrent ligament laxity, avoid secondary osteoarthritis, and achieve early return to sports and work.
Platelet Rich Plasma (PRP)，harvest from peripheral blood, is rich in multiple growth factors(i.e. VEGF, PDGD, TGFB, IGF, EGF) which help the injured tissue regeneration. Bone marrow stem cell has been demonstrated to enhance the injured tissue repair both in vitro and in vivo study.
However, there is no prospective study in comparing the PRP and BMC to enhance interfacial healing between graft and bone tunnel in ACL reconstruction. Investigators hypothesize that the combination of PRP and BMC has synergetic effect in interfacial healing in ACL reconstruction.
Aim of this study： To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.
Detailed description
Anterior cruciate ligament (ACL) is an important stabilizer of knee during daily activity and exercise. According to literature, there are 100,000- 200,000 ACL tear case annually in US. The patients with ACL tear will sustain with joint pain, muscle weakness, giving way sensation, other knee ligaments or meniscus injury, and consequent osteoarthritis change. However, the ruptured ACL cannot heal by itself due to limited vascularity supply, intraarticular inflammatory factors which inhibit the ACL cells migration and proliferation. The ruptured ACL need to be reconstructed by a new tendon graft which passed the bone tunnel and joint during operation. How to enhance the tendon graft to bone tunnel healing is critical important to prevent recurrent ligament laxity, avoid secondary osteoarthritis, and achieve early return to sports and work.
Platelet Rich Plasma (PRP)，harvest from peripheral blood, is rich in multiple growth factors(i.e. VEGF, PDGD, TGFB, IGF, EGF) which help the injured tissue regeneration. The PRP has been applied in treating tendinitis, osteoarthritis, cartilage injury, and bone nonunion. Bone marrow contains lots of stem cell and progenitor cells with capability of self-renewal and multi-differentiation. Bone marrow stem cell has been demonstrated to enhance the injured tissue repair both in vitro and in vivo study. The bone marrow concentrate (BMC) can be isolated from the bone marrow through the centrifuge procedure at one time which contains multiple stem cells. The bone marrow can regenerate itself around 1 week.
In recent years, many authors uses the combination of RPP and BMC to treat injured tissue. However, there is no prospective study in comparing the PRP and BMC to enhance interfacial healing between graft and bone tunnel in ACL reconstruction. Investigators hypothesize that the combination of PRP and BMC has synergetic effect in interfacial healing in ACL reconstruction.
The purpose of this study is to investigate the clinical outcome of autologous PRP, and combined BMC+PRP in tendon graft augmentation in the ACL reconstruction surgery with functional score and MRI evaluation. Investigators will analyze the therapeutic effect using one-way ANOVA. To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.
| Arm | Type | Receives |
|---|---|---|
| PRP augmentation ACL reconstruction group | Experimental | Combination Product: Platelet-Rich Plasma; Bone marrow concentratePlatelet-rich plasma (PRP) (Dosage form: APA-15) |
| PRP+BMC augmentation ACL reconstruction group | Experimental | Combination Product: Platelet-Rich Plasma; Bone marrow concentrateBone marrow concentrate (BMC) (Dosage form: APA-15Q) |
| Traditional ACL reconstruction group | No intervention | –No intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≧ 20 year-old
- the patient has been confirmed ACL rupture and the reconstruction is indicated
- sign IRB and operation consent
Key exclusion criteria (9 listed)
- combined other ligament or extremities injury
- prior the same knee surgery
- open wound or operation history at knee joint
- Severe knee osteoarthritis
- history of multiple joint arthritis or rheumatoid arthritis
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 Plasma; Bone marrow concentratePlatelet-rich plasma (PRP) (Dosage form: APA-15) Bone marrow concentrate (BMC) (Dosage form: APA-15Q) | Combination product | PRP augmentation ACL reconstruction group, PRP+BMC augmentation ACL reconstruction group |
Primary outcome
X-ray
Time frame: preoperative
X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.
X-ray
Time frame: 3 months after ACL reconstruction.
X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.
X-ray
Time frame: 6 months after ACL reconstruction.
X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.
X-ray
Time frame: 12 months after ACL reconstruction.
X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.
MRI
Time frame: preoperative
MRI to evaluate the joint space, graft to bone healing status and graft incorporation.
MRI of operated knee
Time frame: 3 months after ACL reconstruction.
MRI to evaluate the joint space, graft to bone healing status and graft incorporation.
MRI of operated knee
Time frame: 6 months after ACL reconstruction.
MRI to evaluate the joint space, graft to bone healing status and graft incorporation.
MRI of operated knee
Time frame: 12 months after ACL reconstruction.
MRI to evaluate the joint space, graft to bone healing status and graft incorporation.
Lysholm score
Time frame: preoperative
Lysholm score to evaluate the knee function recovery
Lysholm score
Time frame: 3 months after ACL reconstruction.
Lysholm score to evaluate the knee function recovery
Lysholm score
Time frame: 6 months after ACL reconstruction.
Lysholm score to evaluate the knee function recovery
Lysholm score
Time frame: 12 months after ACL reconstruction.
Lysholm score to evaluate the knee function recovery
IKDC 2000
Time frame: preoperative
IKDC 2000 to evaluate the knee function recovery
IKDC 2000
Time frame: 3 months after ACL reconstruction.
IKDC 2000 to evaluate the knee function recovery
IKDC 2000
Time frame: 6 months after ACL reconstruction.
IKDC 2000 to evaluate the knee function recovery
IKDC 2000
Time frame: 12 months after ACL reconstruction.
IKDC 2000 to evaluate the knee function recovery
Muscle power (N.m/kg)
Time frame: preoperative
muscle power test by Biodex System 3 Pro
Muscle power (N.m/kg)
Time frame: 3 months after ACL reconstruction.
muscle power test by Biodex System 3 Pro
Muscle power (N.m/kg)
Time frame: 6 months after ACL reconstruction.
muscle power test by Biodex System 3 Pro
Muscle power (N.m/kg)
Time frame: 12 months after ACL reconstruction.
muscle power test by Biodex System 3 Pro
Proprioception (degree)
Time frame: preoperative
Proprioception test by Biodex System 3 Pro
Proprioception (degree)
Time frame: 3 months after ACL reconstruction.
Proprioception test by Biodex System 3 Pro
Proprioception (degree)
Time frame: 6 months after ACL reconstruction.
Proprioception test by Biodex System 3 Pro
Proprioception (degree)
Time frame: 12 months after ACL reconstruction.
Proprioception test by Biodex System 3 Pro
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 13 Jan 2022.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL 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. This study is not recruiting at the moment.
Pei-Hsi Chou, PhD principal investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
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; Bone marrow concentrate in people with Anterior Cruciate Ligament Reconstruction, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 9 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 13 Jan 2022. 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 Taiwan. 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?
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?
X-ray (time frame: preoperative). The study lists 24 primary outcomes in all. 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 13 Jan 2022.