Clinical trial NCT05953051: Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Tear
Keywords: Anterior Cruciate Ligament Reconstruction
Platelet-Rich Plasma
Bone Tunnel Widening
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be allocated 1:1 on experimental and control arm using block randomization within both genders with random block sizes (randomly chosen from the set \[2,4,6,8\]).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tibial tunnel diameter change
timeFrame: 10 to 14 months post-surgery
measure: Tibial tunnel volume change
timeFrame: 10 to 14 months post-surgery
Secondary outcomes:
measure: Femoral tunnel diameter change
timeFrame: 10 to 14 months post-surgery
measure: Femoral tunnel volume change
timeFrame: 10 to 14 months post-surgery
measure: Graft maturity_subj
timeFrame: 10 to 14 months post-surgery
measure: Graft maturity_obj
timeFrame: 10 to 14 months post-surgery
measure: Graft integration
timeFrame: 10 to 14 months post-surgery
measure: Bone healing and integration
timeFrame: 10 to 14 months post-surgery
Other outcomes:
measure: Range of motion
timeFrame: 10-14 and 20-28 months post-surgery
measure: Isokinetic knee strength test
timeFrame: 10-14 and 20-28 months post-surgery
measure: Y-balance test
timeFrame: 10-14 and 20-28 months post-surgery
measure: Knee Laxity
timeFrame: 10-14 and 20-28 months post-surgery
measure: Front hop
timeFrame: 10-14 and 20-28 months post-surgery
measure: Side hop
timeFrame: 10-14 and 20-28 months post-surgery
measure: gait restrictions
timeFrame: 10-14 and 20-28 months post-surgery
measure: adverse events
timeFrame: 10-14 and 20-28 months post-surgery
measure: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
timeFrame: -3 to 0, 6, 12, 24 months post-surgery
measure: EuroQol visual analogue scale (EQ-VAS)
timeFrame: -3 to 0, 6, 12, 24 months post-surgery
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: -3 to 0, 6, 12, 24 months post-surgery
measure: Tegner Activity Scale
timeFrame: 12, 24 months post-surgery
measure: Return to Sport Injury Scale (ACL-RSI)
timeFrame: 12, 24 months post-surgery
measure: Numeric Rating scale for pain (NRS) in the knee
timeFrame: -3 to 0, 6, 12, 24 months post-surgery
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
Study officials:
affiliation: Schulthess Klinik
name: Gian Salzmann, Prof.
role: PRINCIPAL_INVESTIGATOR
References: