- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05953051
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To be successful, an ACL reconstruction requires a strong incorporation of the tendon to the bone within or at the margin of the tunnel, but the tunnel itself is at risk of widening, therefore compromising the tendon attachment. A composite of harvested healthy autologous bone fragments from the tunnel and autologous thrombin and fibrin, generated from the patient's PrP could be used at the interface between tunnel and ACL graft at the tibia and femur to reduce frequency of tunnel widening and therefore improve graft-bone-integration.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vincent A Stadelmann, PhD
- Phone Number: 75 87 +41 44 385
- Email: vincent.stadelmann@kws.ch
Study Contact Backup
- Name: Anika Stephan, MA
- Phone Number: 79 84 +41 44 385
- Email: anika.stephan@kws.ch
Study Locations
-
-
-
Zürich, Switzerland, 8008
- Recruiting
- Schulthess Klinik
-
Contact:
- Anika Stephan
- Phone Number: +41443857984
- Email: anika.stephan@kws.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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. |
Active Comparator: ACLr standard
No insertion of additional material after ACL graft fixation.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tibial tunnel diameter change
Time Frame: 10 to 14 months post-surgery
|
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
Time Frame: 10 to 14 months post-surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Femoral tunnel diameter change
Time Frame: 10 to 14 months post-surgery
|
Diameter (mm) change of femoral 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 femoral tunnel is defined as the baseline diameter of the femoral tunnel (D0).
Measurements are taken at 4 different levels for the femoral 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
|
Femoral tunnel volume change
Time Frame: 10 to 14 months post-surgery
|
Volume (mm^3) change of femoral 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
|
Graft maturity_subj
Time Frame: 10 to 14 months post-surgery
|
tibial & femoral, subjectively, using a 4-grade system MRI after 12 months based on Proton-density-weighted images
|
10 to 14 months post-surgery
|
Graft maturity_obj
Time Frame: 10 to 14 months post-surgery
|
objectively, within the tibial and femoral tunnels and in the intra-articular portion using the mean intensity of a region of interest on MRI to estimate the graft signal to noise quotient (SNQ) in comparison to the quadriceps tendon: SNQ = Signal intensity graft - Signal intensity quadriceps tendon / SI background
|
10 to 14 months post-surgery
|
Graft integration
Time Frame: 10 to 14 months post-surgery
|
tibial & femoral,
|
10 to 14 months post-surgery
|
Bone healing and integration
Time Frame: 10 to 14 months post-surgery
|
subjectively, tibial & femoral, of the applied autologous bone matrix
|
10 to 14 months post-surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of motion
Time Frame: 10-14 and 20-28 months post-surgery
|
extension and flexion (°) both knees
|
10-14 and 20-28 months post-surgery
|
Isokinetic knee strength test
Time Frame: 10-14 and 20-28 months post-surgery
|
Extension and Flexion (Nm), operated vs. non-operated side
|
10-14 and 20-28 months post-surgery
|
Knee Laxity
Time Frame: 10-14 and 20-28 months post-surgery
|
the patient is placed in the supine position on an examination table, the knees remain at approximately 30° of flexion and the tibia a 15° rotation.
The displacement is consequently measured with the KT-1000 arthrometer device, calculating the relative motion between the sensor pad on the patella and the sensor pad on the anterior tibia under 67, 89 and 134 N force.
The healthy leg is always to be tested first followed by the injured leg.
The side-to-side differences are then evaluated at each force (mm)
|
10-14 and 20-28 months post-surgery
|
gait restrictions
Time Frame: 10-14 and 20-28 months post-surgery
|
gait restrictions related to the operated knee (i.e.
limping) (y/n)
|
10-14 and 20-28 months post-surgery
|
adverse events
Time Frame: 10-14 and 20-28 months post-surgery
|
procedure- and product-related adverse events will be described and given as frequency per type
|
10-14 and 20-28 months post-surgery
|
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Time Frame: -3 to 0, 6, 12, 24 months post-surgery
|
standardized instrument for measuring generic health status regardless of existing diseases within five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), result is a 5-level health state
|
-3 to 0, 6, 12, 24 months post-surgery
|
EuroQol visual analogue scale (EQ-VAS)
Time Frame: -3 to 0, 6, 12, 24 months post-surgery
|
Quality of life, regardless of existing diseases, visual analogue scale from 0 - 100.
0 points correspond to the worst possible health status, while 100 points correspond to the best possible health status.
|
-3 to 0, 6, 12, 24 months post-surgery
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: -3 to 0, 6, 12, 24 months post-surgery
|
assess patient-relevant outcomes following knee injury using 42 items within 5 subscales, which are scored separately; each of the five scores is calculated as the sum of the items included.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
|
-3 to 0, 6, 12, 24 months post-surgery
|
Tegner Activity Scale
Time Frame: 12, 24 months post-surgery
|
one-item score that grades activity based on work and sports activities on a scale of 0 (disability because of knee problems) to 10 (national or international elite level)
|
12, 24 months post-surgery
|
Return to Sport Injury Scale (ACL-RSI)
Time Frame: 12, 24 months post-surgery
|
the patient's self-confidence and risk assessment regarding a return to sport after ACL reconstruction with 12 items using a numeric rating scale of 0 to 100.
|
12, 24 months post-surgery
|
Numeric Rating scale for pain (NRS) in the knee
Time Frame: -3 to 0, 6, 12, 24 months post-surgery
|
unidimensional measure of pain intensity in adults, where 0=no pain and 10=worst possible pain
|
-3 to 0, 6, 12, 24 months post-surgery
|
Y-balance test
Time Frame: 10-14 and 20-28 months post-surgery
|
balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial
|
10-14 and 20-28 months post-surgery
|
Front hop
Time Frame: 10-14 and 20-28 months post-surgery
|
unilateral forward jump as far as possible (cm)
|
10-14 and 20-28 months post-surgery
|
Side hop
Time Frame: 10-14 and 20-28 months post-surgery
|
repeated side hops over a distance of 40 cm and back to start position (number of touch-downs within 30 seconds)
|
10-14 and 20-28 months post-surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gian Salzmann, Prof., Schulthess Klinik
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UE-0073
- 2022-00168 (Other Identifier: BASEC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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