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NCT Number: NCT07573293

BPTB Versus Hamstring Autografts in ACL Reconstruction Among Professional Athletes

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.

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Key information

Conditions

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Al-Ainy Hospital, Cairo University

Cairo, Cairo Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BPTB ACL Reconstruction

Procedure

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

Hamstring ACL Reconstruction

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. International Knee Documentation Committee (IKDC) Score

    Time frame: 12 months postoperatively

    Patient-reported functional outcome measured using the IKDC subjective knee evaluation form.

  2. 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.

  3. Postoperative Complications

    Time frame: Up to 60 months postoperatively

    Incidence of complications including infection, anterior knee pain, extension lag, stiffness, and graft re-rupture.

  4. 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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Kasr Al-Ainy Hospitals

Registry information

Official study title

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

Acronym: BPTB-HT ACL

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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