NCT05191732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
Last Updated

January 13, 2022

Status Verified

September 1, 2021

Enrollment Period

1.9 years

First QC Date

September 30, 2021

Last Update Submit

January 3, 2022

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

Anterior cruciate ligament reconstructionPlatelet-Rich PlasmaBone marrow concentrateHamstring tendon

Outcome Measures

Primary Outcomes (24)

  • X-ray

    X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.

    preoperative

  • X-ray

    X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.

    3 months after ACL reconstruction.

  • X-ray

    X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.

    6 months after ACL reconstruction.

  • X-ray

    X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.

    12 months after ACL reconstruction.

  • MRI

    MRI to evaluate the joint space, graft to bone healing status and graft incorporation.

    preoperative

  • MRI of operated knee

    MRI to evaluate the joint space, graft to bone healing status and graft incorporation.

    3 months after ACL reconstruction.

  • MRI of operated knee

    MRI to evaluate the joint space, graft to bone healing status and graft incorporation.

    6 months after ACL reconstruction.

  • MRI of operated knee

    MRI to evaluate the joint space, graft to bone healing status and graft incorporation.

    12 months after ACL reconstruction.

  • Lysholm score

    Lysholm score to evaluate the knee function recovery

    preoperative

  • Lysholm score

    Lysholm score to evaluate the knee function recovery

    3 months after ACL reconstruction.

  • Lysholm score

    Lysholm score to evaluate the knee function recovery

    6 months after ACL reconstruction.

  • Lysholm score

    Lysholm score to evaluate the knee function recovery

    12 months after ACL reconstruction.

  • IKDC 2000

    IKDC 2000 to evaluate the knee function recovery

    preoperative

  • IKDC 2000

    IKDC 2000 to evaluate the knee function recovery

    3 months after ACL reconstruction.

  • IKDC 2000

    IKDC 2000 to evaluate the knee function recovery

    6 months after ACL reconstruction.

  • IKDC 2000

    IKDC 2000 to evaluate the knee function recovery

    12 months after ACL reconstruction.

  • Muscle power (N.m/kg)

    muscle power test by Biodex System 3 Pro

    preoperative

  • Muscle power (N.m/kg)

    muscle power test by Biodex System 3 Pro

    3 months after ACL reconstruction.

  • Muscle power (N.m/kg)

    muscle power test by Biodex System 3 Pro

    6 months after ACL reconstruction.

  • Muscle power (N.m/kg)

    muscle power test by Biodex System 3 Pro

    12 months after ACL reconstruction.

  • Proprioception (degree)

    Proprioception test by Biodex System 3 Pro

    preoperative

  • Proprioception (degree)

    Proprioception test by Biodex System 3 Pro

    3 months after ACL reconstruction.

  • Proprioception (degree)

    Proprioception test by Biodex System 3 Pro

    6 months after ACL reconstruction.

  • Proprioception (degree)

    Proprioception test by Biodex System 3 Pro

    12 months after ACL reconstruction.

Study Arms (3)

PRP augmentation ACL reconstruction group

EXPERIMENTAL

Platelet-rich plasma (PRP) (Dosage form: APA-15)

Combination Product: Platelet-Rich Plasma; Bone marrow concentrate

PRP+BMC augmentation ACL reconstruction group

EXPERIMENTAL

Bone marrow concentrate (BMC) (Dosage form: APA-15Q)

Combination Product: Platelet-Rich Plasma; Bone marrow concentrate

Traditional ACL reconstruction group

NO INTERVENTION

No intervention

Interventions

Platelet-Rich Plasma; Bone marrow concentrateCOMBINATION_PRODUCT

Platelet-rich plasma (PRP) (Dosage form: APA-15) Bone marrow concentrate (BMC) (Dosage form: APA-15Q)

PRP augmentation ACL reconstruction groupPRP+BMC augmentation ACL reconstruction group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Study Officials

  • Pei-Hsi Chou, PhD

    Kaohsiung Medical University Chung-Ho Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2021

First Posted

January 13, 2022

Study Start

August 3, 2018

Primary Completion

July 4, 2020

Study Completion

July 4, 2020

Last Updated

January 13, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations

TW(1)