Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique
NCT ID: NCT05953051
Last Updated: 2024-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
107 participants
INTERVENTIONAL
2024-01-31
2027-08-31
Brief Summary
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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.
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Detailed Description
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The study seeks primarily to determine less tibial tunnel widening when a bone/PrP-composite is applied directly in the tibial tunnel compared to the same surgery without using the composite, measured with CT and MRI.
Secondary study objectives are to evaluate femoral tunnel widening, tibial and femoral graft incorporation, graft maturation and knee function (clinical, functional, patient reported) over the course of 24 months follow-up and to evaluate occurrence of procedure- and product-related adverse events and complications.
This is a prospective, single-center, single-blinded, 2-arm-parallel, randomized, controlled study with 24 months follow-up. Participants will be recruited from the Knee Surgery department at Schulthess Klinik when scheduled for ACL reconstruction. The study sample comprises 107 patients, allocated 1:1 on experimental and control arm. Outcome measures are taken at 0, 6, 12, and 24 months. The total study duration is 48 months. The study duration per patient is 24 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ACLr with bone/PrP-composite
During 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.
ACL reconstruction with bone/PrP-composite
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.
ACLr standard
No insertion of additional material after ACL graft fixation.
ACL reconstruction (Standard)
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
Interventions
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ACL reconstruction with bone/PrP-composite
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.
ACL reconstruction (Standard)
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
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Schulthess Klinik
OTHER
Responsible Party
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Principal Investigators
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Gian Salzmann, Prof.
Role: PRINCIPAL_INVESTIGATOR
Schulthess Klinik
Locations
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Schulthess Klinik
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-00168
Identifier Type: OTHER
Identifier Source: secondary_id
UE-0073
Identifier Type: -
Identifier Source: org_study_id
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