Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique
A Single-center, Patient-blinded, Randomized, 2-year, Parallel-group, Superiority Study to Compare the Efficacy of Augmented ACL Integration Via Platelet-rich-plasma Enriched Collected Autologous Bone Versus Standard ACL Technique
2 other identifiers
interventional
107
1 country
1
Brief Summary
The purpose of this clinical study is to compare the outcomes of two surgical techniques for reconstruction of the anterior cruciate ligament (ACL) after a single, primary ACL rupture. The main question to be answered is: \- Does less widening of the tibial tunnel occur when a bone/Platelet rich plasma (PrP) composite material is placed directly into the tibial tunnel after fixation of the implant (experimental group) compared to the same surgery without the use of the composite material (control group)? Participants will be randomized into one of the two groups and they will not know which group they belong to. After 12 months they will undergo CT, MRI, medical examination and functional knee testing. They will have a further medical examination and functional knee testing at 24 months. Patient Reported Outcomes will be collected before surgery, 6, 12 and 24 months after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2023
CompletedFirst Posted
Study publicly available on registry
July 19, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
January 29, 2024
January 1, 2024
2.6 years
June 29, 2023
January 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Tibial tunnel diameter change
Diameter (mm) change of tibial tunnel in relation to tunnel diameter reported from surgery; assessed by one radiologist (CT); CT scanning is performed from a level just above the femoral external foramen to a level below the outer hole of the tibial tunnel in order to visualise the positioning of the autograft-fixing metallic devices. The scan is aligned so that the tunnel axis is in the sagittal plane. The diameter of the headed reamer that drilled the tibial tunnel is defined as the baseline diameter of the tibial tunnel (D0). Measurements are taken at 4 different levels for the tibial tunnels using 3D Multiplanar reconstruction. All diameters are calculated in mm within the measurement function of the picture archiving system. The percentage of widening is defined as the difference between initial drilling diameter D0 (derived from surgery report) and post-op measurements D12 in relation to initial drilling diameter D0.
10 to 14 months post-surgery
Tibial tunnel volume change
Volume (mm\^3) change of tibial tunnel in relation to tunnel volume reported from surgery; assessed by one radiologist (CT); the border of the bone tunnel is drawn manually on every fourth slice in both the coronal plane and the sagittal plane and interpolated automatically in between. Based on the contours in those two planes, the contours in the axial plane are interpolated automatically into a 3D mask. The volume of the bone tunnel is determined by automatic voxel counting\^.
10 to 14 months post-surgery
Secondary Outcomes (6)
Femoral tunnel diameter change
10 to 14 months post-surgery
Femoral tunnel volume change
10 to 14 months post-surgery
Graft maturity_subj
10 to 14 months post-surgery
Graft maturity_obj
10 to 14 months post-surgery
Graft integration
10 to 14 months post-surgery
- +1 more secondary outcomes
Other Outcomes (14)
Range of motion
10-14 and 20-28 months post-surgery
Isokinetic knee strength test
10-14 and 20-28 months post-surgery
Y-balance test
10-14 and 20-28 months post-surgery
- +11 more other outcomes
Study Arms (2)
ACLr with bone/PrP-composite
EXPERIMENTALDuring surgery, the drilled bone debris is collected in a sterile filtered chamber. Then the bone debris is mixed with PrP. After fixation of the graft the composite is inserted into the drilled tunnel at the interface between tendon to bone. The intraarticular aperture sites are sealed by use of fibrin that is previously gathered out of the PrP as well.
ACLr standard
ACTIVE COMPARATORNo insertion of additional material after ACL graft fixation.
Interventions
During standard ACL reconstruction, the drilled bone debris is collected in a sterile filtered chamber. Then the bone debris is mixed with PrP. After fixation of the graft the composite is inserted into the drilled tunnel at the interface between tendon to bone. The intraarticular aperture sites are sealed by use of fibrin that is previously gathered out of the PrP as well.
Standard ACL reconstruction with Semitendinosus alone or plus gracilis, femoral fixation via extracortical fixation by adjustable loop device, tibial fixation via a bio-interference screw or adjustable device
Eligibility Criteria
You may qualify if:
- Age 18-50 years
- Primary ACL rupture
- Time from injury to surgery: 4 weeks to 6 months
- Single ACL rupture (isolated rupture)
- ACL surgery with one of the participating senior surgeons
- Informed Consent as documented by signature
You may not qualify if:
- Concomitant ligamentous instability/rupture
- Requirement for Meniscus suture (partial resection accepted, hoop and roots remain intact)
- Requirement for cartilage invasive treatment (debridement accepted)
- Osteoarthritis at index knee joint
- Leg axis deviation over 3° valgus or 4° varus
- Claustrophobia (contra-indication for the MRI)
- Women who are pregnant or breast feeding or intention to become pregnant during the study
- Known or suspected non-compliance, drug or alcohol abuse
- Inability of the patient to follow the study procedures, e.g. language problems, psychological disorders, dementia, etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schulthess Klinik
Zurich, 8008, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gian Salzmann, Prof.
Schulthess Klinik
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Patients are blinded. As well, staff conducting and evaluating MRI, clinical evaluation, CT and functional tests are blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2023
First Posted
July 19, 2023
Study Start
January 1, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2027
Last Updated
January 29, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share
When published, authors will make their data available upon reasonable request or according to the guidelines of the journal.