Anterior Cruciate Ligament InjuryBPTB-HT ACLNCT07573293
BPTB Versus Hamstring Autografts in ACL Reconstruction Among Professional Athletes
A study testing BPTB ACL Reconstruction and Hamstring ACL Reconstruction in people with Anterior Cruciate Ligament Injury, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- BPTB ACL Reconstruction and Hamstring ACL Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- BPTB ACL Reconstruction, Hamstring ACL Reconstruction
- Keywords
- ACL reconstruction, Return to sport, Isokinetic muscle strength, BPTB autograft, Hamstring tendon autograft, Professional athletes
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPTB ACL ReconstructionProcedure or surgery
Arthroscopic anterior cruciate ligament reconstruction using bone-patellar tendon-bone autograft with interference screw fixation.
Hamstring ACL ReconstructionProcedure or surgery
Arthroscopic anterior cruciate ligament reconstruction using semitendinosus and gracilis tendon autograft with appropriate fixation technique.
| Study group | Role | What they receive |
|---|---|---|
| BPTB Group | Experimental | Participants undergoing ACL reconstruction using bone-patellar tendon-bone (BPTB) autograft. Receives: Procedure: BPTB ACL Reconstruction |
| Hamstring Group | Active comparator | Participants undergoing ACL reconstruction using hamstring tendon autograft (semitendinosus and gracilis). Receives: Procedure: Hamstring ACL Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months postoperatively
Secondary outcomes (4)
International Knee Documentation Committee (IKDC) Score
Patient-reported functional outcome measured using the IKDC subjective knee evaluation form.
Measured: 12 months postoperatively
Time to Return to Athletic Activity
Time required for patients to return to pre-injury level of athletic activity.
Measured: Up to 12 months postoperatively
Postoperative Complications
Incidence of complications including infection, anterior knee pain, extension lag, stiffness, and graft re-rupture.
Measured: Up to 60 months postoperatively
Knee function using KOOS score
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).
Measured: 60 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Feb 2018
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to two parallel groups undergoing ACL reconstruction using either BPTB or hamstring tendon autografts.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Principal investigator, Mahmoud Ahmed El-Desouky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573293
- Sponsor's protocol ID
- N-360-2017
- Acronym
- BPTB-HT ACL
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07573293
- Acronym / sponsor ID
- BPTB-HT ACL / N-360-2017
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- ACL reconstruction, Return to sport, Isokinetic muscle strength, BPTB autograft, Hamstring tendon autograft, Professional athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to two parallel groups undergoing ACL reconstruction using either BPTB or hamstring tendon autografts.
| Arm | Type | Receives |
|---|---|---|
| BPTB Group | Experimental | Procedure: BPTB ACL ReconstructionParticipants undergoing ACL reconstruction using bone-patellar tendon-bone (BPTB) autograft. |
| Hamstring Group | Active comparator | Procedure: Hamstring ACL ReconstructionParticipants undergoing ACL reconstruction using hamstring tendon autograft (semitendinosus and gracilis). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPTB ACL ReconstructionArthroscopic anterior cruciate ligament reconstruction using bone-patellar tendon-bone autograft with interference screw fixation. | Procedure or surgery | BPTB Group |
| Hamstring ACL ReconstructionArthroscopic anterior cruciate ligament reconstruction using semitendinosus and gracilis tendon autograft with appropriate fixation technique. | Procedure or surgery | Hamstring Group |
Primary outcome
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.
4 secondary outcomes
International Knee Documentation Committee (IKDC) Score
Time frame: 12 months postoperatively
Time to Return to Athletic Activity
Time frame: Up to 12 months postoperatively
Postoperative Complications
Time frame: Up to 60 months postoperatively
Knee function using KOOS score
Time frame: 60 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPTB ACL Reconstruction and Hamstring ACL Reconstruction in people with Anterior Cruciate Ligament Injury, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic Quadriceps and Hamstring Muscle Strength (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.