Clinical trial NCT05191732: Effect of PRP Versus BMC in Anterior Cruciate Ligament Reconstruction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Anterior cruciate ligament reconstruction
Platelet-Rich Plasma
Bone marrow concentrate
Hamstring tendon
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2022-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Age ≧ 20 year-old
* the patient has been confirmed ACL rupture and the reconstruction is indicated
* sign IRB and operation consent

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: X-ray
timeFrame: preoperative
measure: X-ray
timeFrame: 3 months after ACL reconstruction.
measure: X-ray
timeFrame: 6 months after ACL reconstruction.
measure: X-ray
timeFrame: 12 months after ACL reconstruction.
measure: MRI
timeFrame: preoperative
measure: MRI of operated knee
timeFrame: 3 months after ACL reconstruction.
measure: MRI of operated knee
timeFrame: 6 months after ACL reconstruction.
measure: MRI of operated knee
timeFrame: 12 months after ACL reconstruction.
measure: Lysholm score
timeFrame: preoperative
measure: Lysholm score
timeFrame: 3 months after ACL reconstruction.
measure: Lysholm score
timeFrame: 6 months after ACL reconstruction.
measure: Lysholm score
timeFrame: 12 months after ACL reconstruction.
measure: IKDC 2000
timeFrame: preoperative
measure: IKDC 2000
timeFrame: 3 months after ACL reconstruction.
measure: IKDC 2000
timeFrame: 6 months after ACL reconstruction.
measure: IKDC 2000
timeFrame: 12 months after ACL reconstruction.
measure: Muscle power (N.m/kg)
timeFrame: preoperative
measure: Muscle power (N.m/kg)
timeFrame: 3 months after ACL reconstruction.
measure: Muscle power (N.m/kg)
timeFrame: 6 months after ACL reconstruction.
measure: Muscle power (N.m/kg)
timeFrame: 12 months after ACL reconstruction.
measure: Proprioception (degree)
timeFrame: preoperative
measure: Proprioception (degree)
timeFrame: 3 months after ACL reconstruction.
measure: Proprioception (degree)
timeFrame: 6 months after ACL reconstruction.
measure: Proprioception (degree)
timeFrame: 12 months after ACL reconstruction.
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Pei-Hsi Chou, PhD
role: PRINCIPAL_INVESTIGATOR
References: