Effect of PRP Versus BMC in Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Reconstruction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05191732
• Other study ID #: KMUHIRB-F(I)-20170122
• Status: Completed
• Phase: N/A
• Start date: August 3, 2018
• Est. completion date: July 4, 2020

Study information

• Verified date: September 2021
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 4, 2020
• Est. primary completion date: July 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Combination Product:
• Platelet-Rich Plasma; Bone marrow concentrate
Platelet-rich plasma (PRP) (Dosage form: APA-15) Bone marrow concentrate (BMC) (Dosage form: APA-15Q)

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Ministry of Health and Welfare, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	X-ray	X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.	preoperative
Primary	X-ray	X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.	3 months after ACL reconstruction.
Primary	X-ray	X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.	6 months after ACL reconstruction.
Primary	X-ray	X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.	12 months after ACL reconstruction.
Primary	MRI	MRI to evaluate the joint space, graft to bone healing status and graft incorporation.	preoperative
Primary	MRI of operated knee	MRI to evaluate the joint space, graft to bone healing status and graft incorporation.	3 months after ACL reconstruction.
Primary	MRI of operated knee	MRI to evaluate the joint space, graft to bone healing status and graft incorporation.	6 months after ACL reconstruction.
Primary	MRI of operated knee	MRI to evaluate the joint space, graft to bone healing status and graft incorporation.	12 months after ACL reconstruction.
Primary	Lysholm score	Lysholm score to evaluate the knee function recovery	preoperative
Primary	Lysholm score	Lysholm score to evaluate the knee function recovery	3 months after ACL reconstruction.
Primary	Lysholm score	Lysholm score to evaluate the knee function recovery	6 months after ACL reconstruction.
Primary	Lysholm score	Lysholm score to evaluate the knee function recovery	12 months after ACL reconstruction.
Primary	IKDC 2000	IKDC 2000 to evaluate the knee function recovery	preoperative
Primary	IKDC 2000	IKDC 2000 to evaluate the knee function recovery	3 months after ACL reconstruction.
Primary	IKDC 2000	IKDC 2000 to evaluate the knee function recovery	6 months after ACL reconstruction.
Primary	IKDC 2000	IKDC 2000 to evaluate the knee function recovery	12 months after ACL reconstruction.
Primary	Muscle power (N.m/kg)	muscle power test by Biodex System 3 Pro	preoperative
Primary	Muscle power (N.m/kg)	muscle power test by Biodex System 3 Pro	3 months after ACL reconstruction.
Primary	Muscle power (N.m/kg)	muscle power test by Biodex System 3 Pro	6 months after ACL reconstruction.
Primary	Muscle power (N.m/kg)	muscle power test by Biodex System 3 Pro	12 months after ACL reconstruction.
Primary	Proprioception (degree)	Proprioception test by Biodex System 3 Pro	preoperative
Primary	Proprioception (degree)	Proprioception test by Biodex System 3 Pro	3 months after ACL reconstruction.
Primary	Proprioception (degree)	Proprioception test by Biodex System 3 Pro	6 months after ACL reconstruction.
Primary	Proprioception (degree)	Proprioception test by Biodex System 3 Pro	12 months after ACL reconstruction.