Comparison of Bone-patellar Tendon-bone and Patellar Tendon-bone Grafts in ACL Reconstruction

Comparison of Morbidity and Functional Outcomes After Anterior Cruciate Ligament Reconstruction With Bone-Tendon-Bone Graft Versus Patellar Tendon Graft Without Patellar Bone Plug in Competitive Athletes

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:

• Does PT graft reduce donor site morbidity compared to the standard BPTB graft?
• Does PT technique provide clinical and functional results comparable to the BPTB technique? Researchers will compare the incidence of complications and clinical and functional outcomes between the BPTB and PT grafts groups.

Patients will:

• Undergo ACLR surgical intervention using one of the two assigned techniques (BPTB or PT)
• Follow a two-year assessment program, including visits at three, eight, 12 and 24 months after surgery.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament (ACL) Reconstruction
• Intervention / Treatment: Procedure: Patellar tendon-Bone; Procedure: Bone-Patellar tendon-Bone

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose M Rodriguez-Delgado; Phone Number: +34664807986; Email: josemariard@ugr.es
• Study Contact Backup: Name: Jose Luis Martin-Alguacil; Phone Number: +34666523667; Email: joseluismartinalguacil@hotmail.com

Study Locations

• Spain
  • Granada
    • Granada, Granada, Spain, 18016
      • Recruiting
      • Health Sciences Faculty, University of Granada
      • Contact: Jose M Rodriguez-Delgado; Phone Number: +34664807986; Email: josemariard@ugr.es
      • Principal Investigator: Manuel Arroyo-Morales
      • Principal Investigator: Jose Luis Martin-Alguacil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Time for injury to surgery of less than six months.
• Active athletes (federated or recreational)
• Patellar tendon length > 42mm measured by MRI.
• Age between 12 and 40 years old
• Genders eligible for Study: both

Exclusion Criteria:

• Previous surgery or history of ligamentous knee injuries.
• Concomitant knee ligament injury
• Major meniscal injury (more than 50% of the lateral or medial meniscus)
• Chondral injury greater than Outerbridge Grade I-II

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patellar tendon - Bone (PT)	Procedure: Patellar tendon-Bone; 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: Minimum length: 42mm; Width-based harvesting: if the tendon width is <30mm, a graft consisting of one-third of the total width is harvested. If the width exceeds 30mm, a 10mm wide graft is obtained.; Bone plugs: a tibial bone plug (10x20x8mm) is harvested. While the graft is prepared, anatomic tunnels are created. The graft is secured with MectaScrew (MEDACTA) interference screws. Once fixed, an extra-articular tenodesis is performed using Arnold & Coker technique.; Other Names: Patellar tendon
Active Comparator: Bone - Patellar tendon - Bone (BPTB)	Procedure: Bone-Patellar tendon-Bone; 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: Minimum length: 42mm; Width-based harvesting: if the tendon width is <30mm, a graft consisting of one-third of the total width is harvested. If the width exceeds 30mm, a 10mm wide graft is obtained.; Bone plugs: patellar and tibial bone plugs (10x20x8mm) are harvested. While the graft is prepared, anatomic tunnels are created. The graft is secured with MectaScrew (MEDACTA) interference screws. Once fixed, an extra-articular tenodesis is performed using Arnold & Coker technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	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

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Study Chair: Manuel Arroyo-Morales, Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION; BONE PATELLAR TENDON BONE; PATELLAR TENDON
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Therapeutics; Surgical Procedures, Operative; Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Tissue Transplantation; Anterior Cruciate Ligament Reconstruction; Bone-Patellar Tendon-Bone Grafting
• Other Study ID Numbers: P36/24/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No