NCT07573293

Brief Summary

This prospective randomized controlled study compares outcomes of ACL reconstruction using bone-patellar tendon-bone (BPTB) versus hamstring tendon (HT) autografts in professional athletes. The primary outcome is isokinetic muscle strength assessment. Secondary outcomes include IKDC score, return to athletic activity, and complication rates. Patients are followed for five years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2018

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

7.4 years

First QC Date

April 30, 2026

Last Update Submit

May 1, 2026

Conditions

Keywords

ACL reconstructionReturn to sportIsokinetic muscle strengthBPTB autograftHamstring tendon autograftProfessional athletes

Outcome Measures

Primary Outcomes (1)

  • Isokinetic Quadriceps and Hamstring Muscle Strength

    Isokinetic dynamometric assessment of quadriceps and hamstring muscle strength expressed as peak torque percentage relative to the contralateral limb using a standardized testing protocol.

    12 months postoperatively

Secondary Outcomes (4)

  • International Knee Documentation Committee (IKDC) Score

    12 months postoperatively

  • Time to Return to Athletic Activity

    Up to 12 months postoperatively

  • Postoperative Complications

    Up to 60 months postoperatively

  • Knee function using KOOS score

    60 months postoperatively

Study Arms (2)

BPTB Group

EXPERIMENTAL

Participants undergoing ACL reconstruction using bone-patellar tendon-bone (BPTB) autograft.

Procedure: BPTB ACL Reconstruction

Hamstring Group

ACTIVE COMPARATOR

Participants undergoing ACL reconstruction using hamstring tendon autograft (semitendinosus and gracilis).

Procedure: Hamstring ACL Reconstruction

Interventions

Arthroscopic anterior cruciate ligament reconstruction using bone-patellar tendon-bone autograft with interference screw fixation.

BPTB Group

Arthroscopic anterior cruciate ligament reconstruction using semitendinosus and gracilis tendon autograft with appropriate fixation technique.

Hamstring Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Professional athletes actively engaged in competitive sports
  • Age between 18 and 35 years
  • Primary isolated anterior cruciate ligament (ACL) rupture confirmed clinically and by MRI
  • Indicated for arthroscopic ACL reconstruction
  • Willingness to participate and provide informed consent

You may not qualify if:

  • Multiligamentous knee injuries
  • Previous ACL reconstruction on the affected knee
  • Lower limb malalignment
  • Advanced chondral lesions requiring additional surgical procedures
  • Associated fractures around the knee
  • Inability to comply with follow-up protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al-Ainy Hospital, Cairo University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to two parallel groups undergoing ACL reconstruction using either BPTB or hamstring tendon autografts.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Orthopedic Surgery

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 7, 2026

Study Start

February 1, 2018

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations