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The purpose of this randomized study is to compare donor site morbidity and clinical and functional outcomes of both surgery techniques (bone-patellar tendon-bone (BPTB) graft versus bone-patellar tendon without patellar bone plug (PT) graft) for anterior cruciate ligament reconstruction (ACLR) in athletes. The main questions it aims to answer are:
Patients will:
Anterior cruciate ligament (ACL) rupture is the most prevalent type of knee ligament injury, representing approximately 50% of all reported knee injuries. This injury has a particularly high impact on most athletes due to the demands of pivoting, jumping and cutting movements required during play. In addition, its consequences include a prolonged recovery period, the risk of reinjury and complications arising from ACL insufficiency, such as knee instability, meniscal tears or osteoarthritis. Given that the primary indicator of successful treatment is the athlete's ability to return to competitive levels, surgical reconstruction of the ACL (ACLR) has become the standard treatment. However, the choice of the optimal graft for ACLR remains controversial. For many authors, bone-patellar tendon-bone (BPTB) graft is considered gold-standard option due to optimal biomechanical properties and low reinjury rate. However, BPTB is usually associated with donor site morbidity, specifically related to kneeling, dysesthesia and anterior knee pain.
Given the disadvantages of the BPTB graft, an ACLR based on a bone-patellar tendon graft may be a viable alternative. This technique utilizes an autograft composed of the central third of the patellar tendon and a tibial tubercle bone plug without inclusion of the patellar bone plug, called bone-patellar tendon (BPT). Previous studies have demonstrated lower rates of anterior knee pain in BPT compared to BPTB. However, there is a lack of evidence regarding objective and specific donor site morbidity assessment for both techniques.
The main hipothesis of this study is that BPT has similar clinical an functional recovery compared to BPTB with lower rates of anterior knee morbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patellar tendon - Bone (PT) | Active Comparator |
| |
| Bone - Patellar tendon - Bone (BPTB) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone-Patellar tendon-Bone | Procedure | After an arthroscopic examination via an anterolateral viewing portal to confirm the ACL injury, two additional portals will be established: an accessory medial portal slightly above the joint line (approximately 2cm from the medial border of the patellar tendon) and a high anteromedial portal. Once associated lesions are addressed, the graft is harvested through a 6cm longitudinal midline incision. Following paratenon dissection, the patellar tendon dimensions are measured:
|
| Measure | Description | Time Frame |
|---|---|---|
| Donor Site Morbidity | Anterior Cruciate Ligament Donor-site Morbidity Questionnaire will be used to evaluate complications at the harvest site. Scores range from 0 to 100 points, where higher scores indicates better ouctome (absence of donor-site complications). | At 3, 8, 12 and 24 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Function and activity level | Lysholm-Tegner score will be used to report knee function and activity level. Scores range from 0 to 100 points, where 100 indicates a better outcome (knee function). | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Subjective knee status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose M Rodriguez-Delgado | Contact | +34664807986 | josemariard@ugr.es | |
| Jose Luis Martin-Alguacil | Contact | +34666523667 | joseluismartinalguacil@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Manuel Arroyo-Morales | Universidad de Granada | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Faculty, University of Granada | Recruiting | Granada | Granada | 18016 | Spain |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D050376 | Bone-Patellar Tendon-Bone Grafting |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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|
| Patellar tendon-Bone | Procedure | After an arthroscopic examination via an anterolateral viewing portal to confirm the ACL injury, two additional portals will be established: an accessory medial portal slightly above the joint line (approximately 2cm from the medial border of the patellar tendon) and a high anteromedial portal. Once associated lesions are addressed, the graft is harvested through a 6cm longitudinal midline incision. Following paratenon dissection, the patellar tendon dimensions are measured:
|
|
|
International Knee Documentation Committee (IKDC) will be used to assess knee signs and symptoms. Total scores range from 0 to 100 points, where a higher score indicates a better outcome (absence of symptoms and maximum functional level). |
| Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Psychological readiness | Anterior cruciate ligament - Return to Sport after Injury (ACL-RSI) Scale will be used to evaluate psychological readiness of patients to return to sport after ACL reconstruction. Scores range from 0 to 100 points, where a higher score indicates better outcome (full psychological readiness and confidence). | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Joint Awareness | Forgotten Joint Score (FJS) will be used to assessthe patient's ability to forget their affected joint during activities. Scores range from 0 to 100 points, where higher scores indicate a better outcome (patients "forget" the joint, representing a natural feel). | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Patient-reported symptoms | Cincinnati Knee Rating System will be used to ievaluate patient-reported symptoms. scores range from 0 to 100 points, where a higher score (100) indicates better outcome (excellent clinical result, no symptoms, and full return to sports). | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Quadriceps strength | Isokinetic test will be used to evaluate quadriceps peak torque and limb symmetry index. After a warm-up of 10 minutes, patients will perform 5 and 10 unilateral repetitions at 60 and 180º/s respectively, with one minute of rest between series. | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Hamstrings strength | Isokinetic test will be used to evaluate hamstrings peak torque and limb symmetry index. After a warm-up of 10 minutes, patients will perform 5 and 10 unilateral repetitions at 60 and 180º/s respectively, with one minute of rest between series. | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Hamstring/Quadriceps ratio | HQ ratio will be calculated with hamstring and quadriceps peak torque from isokinetic tests. | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Functional Hop Test Battery | A series of four hop tests will be performed to measure dynamic stability and neuromuscular control. Distance and limb symmetry index will be registered. | Baseline (Pre-intervention) and 8, 12 and 24 months after surgery |
| Donor-site pain pressure threshold | Pain pressure threshold measured via digital algometry will be used at the patellar tendon. | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Quadriceps thickness | An ultrasound system with a linear probe will be used to measure quadriceps thickness. | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Patellar tendon morphology | An ultrasound system with a linear probe will be used to measure patellar tendon thickness and cross-sectional area. | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Anteroposterior knee stability | A Lachmeter system will be used to evaluate anteroposterior knee stability | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Knee stability | A KIRA system will be used to evaluate anteroposterior and rotational knee stability | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Height | A tallimeter will be used to register height, expressed in meters (m). | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Weight | Bioelectrical impedance analysis (BIA) will be performed by using an Inbody 970 for measuring weight, expressed in kilograms (kg). | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Body Mass Index (BMI) | Bioelectrical impedance analysis (BIA) will be performed by using an Inbody 970 for measuring BMI, expressed in kg/m^2. | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Percentage of Body Fat | Bioelectrical impedance analysis (BIA) will be performed by using an Inbody 970 for measuring PBF, expressed in %. | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| Skeletal Muscle Mass | Bioelectrical impedance analysis (BIA) will be performed by using an Inbody 970 for measuring SMM, expressed in kg. | Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery |
| D059549 |
| Anterior Cruciate Ligament Reconstruction |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D014180 | Transplantation |