NCT07475351

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Jan 2026Mar 2028

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 11, 2026

Last Update Submit

March 18, 2026

Conditions

Anterior Cruciate Ligament (ACL) ReconstructionAnterior Cruciate Ligament Injury

Keywords

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTIONBONE PATELLAR TENDON BONEPATELLAR TENDON

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (19)

  • Function and activity level

    Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery

  • Subjective knee status

    Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery

  • Psychological readiness

    Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery

  • Joint Awareness

    Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery

  • Patient-reported symptoms

    Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery

  • +14 more secondary outcomes

Study Arms (2)

Patellar tendon - Bone (PT)

ACTIVE COMPARATOR
Procedure: Patellar tendon-Bone

Bone - Patellar tendon - Bone (BPTB)

ACTIVE COMPARATOR
Procedure: Bone-Patellar tendon-Bone

Interventions

Bone-Patellar tendon-BonePROCEDURE

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.

Bone - Patellar tendon - Bone (BPTB)
Patellar tendon-BonePROCEDURE

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.

Also known as: Patellar tendon
Patellar tendon - Bone (PT)

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Faculty, University of Granada

Granada, Granada, 18016, Spain

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Bone-Patellar Tendon-Bone Grafting

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsAnterior Cruciate Ligament ReconstructionArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresTransplantation

Study Officials

  • Manuel Arroyo-Morales

    Universidad de Granada

    STUDY CHAIR

Central Study Contacts

Jose M Rodriguez-Delgado

CONTACT

+34664807986josemariard@ugr.es

Jose Luis Martin-Alguacil

CONTACT

+34666523667joseluismartinalguacil@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC, PT

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)