BPTB Versus Hamstring Autografts in ACL Reconstruction Among Professional Athletes (BPTB-HT ACL)

May 1, 2026 updated by: Mahmoud Ahmed El-Desouky, Cairo University

Bone-Patellar Tendon-Bone Versus Hamstring Tendon Autografts in ACL Reconstruction Among Professional Athletes: A Prospective Randomized Controlled Study With Mid-term Follow-up

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial evaluates BPTB versus HT autografts in professional athletes undergoing ACL reconstruction. Patients with isolated ACL rupture were randomly assigned to either graft.

All procedures and rehabilitation protocols were standardized. The primary outcome was isokinetic assessment of quadriceps and hamstring strength using a dynamometer. Secondary outcomes included IKDC score, return to sport, and complications.

Patients were followed for five years to assess functional recovery and long-term outcomes.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Kasr Al-Ainy Hospital, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BPTB Group
Participants undergoing ACL reconstruction using bone-patellar tendon-bone (BPTB) autograft.
Procedure: BPTB ACL Reconstruction
Arthroscopic anterior cruciate ligament reconstruction using bone-patellar tendon-bone autograft with interference screw fixation.
Active Comparator: Hamstring Group
Participants undergoing ACL reconstruction using hamstring tendon autograft (semitendinosus and gracilis).
Procedure: Hamstring ACL Reconstruction
Arthroscopic anterior cruciate ligament reconstruction using semitendinosus and gracilis tendon autograft with appropriate fixation technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isokinetic Quadriceps and Hamstring Muscle Strength
Time Frame: 12 months postoperatively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Knee Documentation Committee (IKDC) Score
Time Frame: 12 months postoperatively
Patient-reported functional outcome measured using the IKDC subjective knee evaluation form.
12 months postoperatively
Time to Return to Athletic Activity
Time Frame: Up to 12 months postoperatively
Time required for patients to return to pre-injury level of athletic activity.
Up to 12 months postoperatively
Postoperative Complications
Time Frame: Up to 60 months postoperatively
Incidence of complications including infection, anterior knee pain, extension lag, stiffness, and graft re-rupture.
Up to 60 months postoperatively
Knee function using KOOS score
Time Frame: 60 months postoperatively

Patient-reported outcomes assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), including subscales:

  • Pain
  • Symptoms
  • Sport and Recreation
  • Quality of Life

Scores reported on a 0-100 scale (higher scores indicate better function).
60 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Kasr Al-Ainy Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-360-2017

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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