Anterior Cruciate Ligament InjuryNCT07876635
Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
An observational study of Anterior Cruciate Ligament Injury and Tunneling Technique, run by Sakarya University at 2 sites in Turkey (Türkiye).
Trial summary
Anterior cruciate ligament (ACL) rupture is a common and clinically significant injury, particularly among young, active, and athletic adults, and may lead to knee instability and functional impairment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Tunneling Technique, Tendon Graft; Complication, Mechanical
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 2 Jan 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population will consist of patients diagnosed with anterior cruciate ligament (ACL) rupture who are scheduled to undergo primary ACL reconstruction at our institution. Eligible participants will be prospectively enrolled and followed postoperatively for clinical, functional, and radiological outcomes.
Who may be able to join
- Patients aged 18-50 years.
- Patients diagnosed with unilateral anterior cruciate ligament (ACL) injury.
- Patients scheduled to undergo primary ACL reconstruction.
- Patients who are willing and able to complete a postoperative follow-up period of at least 6 months.
- Patients with available postoperative radiological assessments, including computed tomography (CT), magnetic resonance imaging (MRI), and/or standard radiographs, as required by the study protocol.
- Patients with clinical outcome assessments, including the Lysholm Knee Score and International Knee Documentation Committee (IKDC) score, recorded during the planned follow-up period.
Who cannot join
- Patients with multiligament knee injuries, including clinically significant concomitant posterior cruciate ligament (PCL), medial collateral ligament (MCL), or lateral collateral ligament (LCL) injuries.
- Patients with a history of previous non-ACL surgery on the affected knee.
- Patients with advanced knee osteoarthritis.
- Patients who develop a postoperative infection.
- Patients with insufficient or inadequate radiological imaging data for the planned assessments.
- Patients who do not complete at least 6 months of postoperative follow-up.
- Patients with neuromuscular disorders or systemic connective tissue diseases.
- Patients with incomplete or inadequately recorded clinical outcome scores.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Sakarya Üniversitesi Eğitim Ve Araştirma Hastanesi
Sakarya
Department of Orthopedics and Traumatology Department of Orthopedics and Traumatology, 444 5 400, sakaryaeah@saglik.gov.tr
- Recruiting
Sakarya Üniversitesi Eğitim Ve Araştirma Hastanesi
Sakarya
Department of Orthopedics and Traumatology, 444 5 400, sakaryaeah@saglik.gov.tr
About this study
Official title: EVALUATION OF THE CORRELATION BETWEEN BONE TUNNEL PROJECTION PLACEMENT AND CLINICAL OUTCOMES IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY
Anterior cruciate ligament (ACL) rupture is a common and clinically significant injury, particularly among young, active, and athletic adults, and may lead to knee instability and functional impairment. The resulting instability can limit activities of daily living and reduce sports performance, often increasing the need for surgical treatment in physically active individuals. Therefore, ACL reconstruction is widely accepted as an effective treatment option in appropriately selected patients.
In the assessment of patients undergoing ACL reconstruction, not only postoperative clinical success but also the degree of preoperative instability may be important. Determining the effect of preoperative instability severity and side-to-side difference on postoperative functional outcomes, clinical recovery, radiological findings, return to daily activities, and return to sports may provide a more comprehensive and objective evaluation of surgical success.
Read more
Although several studies have investigated clinical outcomes after ACL reconstruction, prospective studies evaluating the impact of preoperative instability on postoperative outcomes together with clinical, functional, and radiological parameters remain limited, particularly in our country.
This prospective study aims to investigate the relationship between preoperative knee instability and postoperative clinical, functional, and radiological outcomes in patients undergoing ACL reconstruction at our institution. The findings are expected to contribute to the existing literature and provide useful information for clinical practice.
Read the detailed description
Functional Assessment
To evaluate postoperative functional recovery, the Lysholm Knee Score, IKDC-2000 score, and Lachman test, which are routinely used in our clinical practice, will be applied. In addition, the time required for patients to return to activities of daily living, sports participation, and their usual daily routines will be recorded. The maintenance of postoperative well-being, the time required to resume preoperative sporting activities, and whether full functional recovery is achieved will also be analyzed.
During the preoperative period, patients will undergo a detailed physical examination for knee instability. Objective instability will be assessed using a Rolimeter, and the measured anterior tibial translation will be compared with the contralateral healthy knee to determine the degree of preoperative side-to-side instability. The association between preoperative instability severity and postoperative clinical and functional outcomes will subsequently be evaluated.
Surgical and Reconstruction Technique
Anterior cruciate ligament reconstruction will be performed according to the standard surgical principles routinely applied at our institution, in accordance with current literature, evidence-based practice, and contemporary scientific recommendations. Intraoperative variables, including graft type, graft harvest site, graft size, and femoral and tibial tunnel placement, will be recorded. The relationship between these surgical parameters and postoperative clinical and functional outcomes will also be assessed.
Radiological and Clinical Follow-Up
Patients will undergo routine postoperative radiological and clinical evaluations. On postoperative day 0, standard anteroposterior and lateral knee radiographs together with routine computed tomography imaging will be obtained to assess tunnel position and the early characteristics of the reconstruction.
At the 3-month follow-up, the effectiveness of the rehabilitation program and the patient's functional status will be evaluated by physical examination, computed tomography, and radiographs. At the 6-month follow-up, return to an active lifestyle and sports participation will be assessed together with clinical and radiological findings. During follow-up, tunnel position, tunnel dimensions, graft adaptation, and the healing process will be evaluated radiologically.
Complications and Local Evaluation
Postoperative complications occurring during follow-up will be recorded in detail. These will include infection, tunnel widening, fracture, wound-healing problems, tunnel malposition, graft laxity, recurrent clinical instability, and graft rerupture. All complications will be analyzed together with clinical examination findings and radiological assessments.
Statistical Analysis
All collected data will be analyzed using appropriate statistical methods. The effects of graft type, graft size, graft harvest site, and femoral and tibial tunnel dimensions and positions on return to normal active life and sports, functional recovery, and postoperative clinical outcomes will be evaluated.
In addition, the relationship between the degree of preoperative knee instability and postoperative clinical, functional, and radiological outcomes will be statistically assessed.
Through this methodological approach, the study aims to identify factors associated with postoperative functional outcomes following anterior cruciate ligament reconstruction and to evaluate the influence of graft characteristics and femoral and tibial tunnel placement on clinical success.
- Conditions
- Anterior Cruciate Ligament Injury, Tunneling Technique, Tendon Graft; Complication, Mechanical
- Keywords
- Anterior Cruciate Ligament, ACL Reconstruction, Femoral Tunnel, Tibial Tunnel, Tunnel Position
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing ACL Reconstruction | ACL Reconstruction Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm Knee Score
Postoperative knee function will be assessed using the Lysholm Knee Score. The score ranges from 0 to 100, with higher scores indicating better knee function. The association between preoperative knee instability measured using the Rolimeter and postoperative Lysholm scores will be evaluated.
Measured: 1 YEAR
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score
Postoperative knee function will be assessed using the IKDC Subjective Knee Evaluation Score. Scores range from 0 to 100, with higher scores indicating better symptoms, function, and sports activity. The relationship between preoperative knee instability and postoperative IKDC scores will be analyzed.
Measured: 1 YEAR
Secondary outcomes (1)
Return to Normal Active Life
The time required for participants to return to their normal active daily life after anterior cruciate ligament reconstruction will be recorded. This will include resumption of routine daily activities, work-related activities, and usual physical activity levels.
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Jun 2026
- Primary completion2 Jan 2027 (estimated)
- Study completion2 Jan 2028 (estimated)
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 Sakarya 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zekrullahziyai, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876635
- Sponsor's protocol ID
- E-43012747-050.04-590513-450
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE CORRELATION BETWEEN BONE TUNNEL PROJECTION PLACEMENT AND CLINICAL OUTCOMES IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY
- ClinicalTrials.gov ID
- NCT07876635
- Acronym / sponsor ID
- E-43012747-050.04-590513-450
- Conditions
- Anterior Cruciate Ligament Injury, Tunneling Technique, Tendon Graft; Complication, Mechanical
- Keywords
- Anterior Cruciate Ligament, ACL Reconstruction, Femoral Tunnel, Tibial Tunnel, Tunnel Position
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 Jan 2028 (estimated)
- First posted
- 15 Oct 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.
Anterior cruciate ligament (ACL) rupture is a common and clinically significant injury, particularly among young, active, and athletic adults, and may lead to knee instability and functional impairment. The resulting instability can limit activities of daily living and reduce sports performance, often increasing the need for surgical treatment in physically active individuals. Therefore, ACL reconstruction is widely accepted as an effective treatment option in appropriately selected patients.
In the assessment of patients undergoing ACL reconstruction, not only postoperative clinical success but also the degree of preoperative instability may be important. Determining the effect of preoperative instability severity and side-to-side difference on postoperative functional outcomes, clinical recovery, radiological findings, return to daily activities, and return to sports may provide a more comprehensive and objective evaluation of surgical success.
Although several studies have investigated clinical outcomes after ACL reconstruction, prospective studies evaluating the impact of preoperative instability on postoperative outcomes together with clinical, functional, and radiological parameters remain limited, particularly in our country.
This prospective study aims to investigate the relationship between preoperative knee instability and postoperative clinical, functional, and radiological outcomes in patients undergoing ACL reconstruction at our institution. The findings are expected to contribute to the existing literature and provide useful information for clinical practice.
Detailed description
Functional Assessment
To evaluate postoperative functional recovery, the Lysholm Knee Score, IKDC-2000 score, and Lachman test, which are routinely used in our clinical practice, will be applied. In addition, the time required for patients to return to activities of daily living, sports participation, and their usual daily routines will be recorded. The maintenance of postoperative well-being, the time required to resume preoperative sporting activities, and whether full functional recovery is achieved will also be analyzed.
During the preoperative period, patients will undergo a detailed physical examination for knee instability. Objective instability will be assessed using a Rolimeter, and the measured anterior tibial translation will be compared with the contralateral healthy knee to determine the degree of preoperative side-to-side instability. The association between preoperative instability severity and postoperative clinical and functional outcomes will subsequently be evaluated.
Surgical and Reconstruction Technique
Anterior cruciate ligament reconstruction will be performed according to the standard surgical principles routinely applied at our institution, in accordance with current literature, evidence-based practice, and contemporary scientific recommendations. Intraoperative variables, including graft type, graft harvest site, graft size, and femoral and tibial tunnel placement, will be recorded. The relationship between these surgical parameters and postoperative clinical and functional outcomes will also be assessed.
Radiological and Clinical Follow-Up
Patients will undergo routine postoperative radiological and clinical evaluations. On postoperative day 0, standard anteroposterior and lateral knee radiographs together with routine computed tomography imaging will be obtained to assess tunnel position and the early characteristics of the reconstruction.
At the 3-month follow-up, the effectiveness of the rehabilitation program and the patient's functional status will be evaluated by physical examination, computed tomography, and radiographs. At the 6-month follow-up, return to an active lifestyle and sports participation will be assessed together with clinical and radiological findings. During follow-up, tunnel position, tunnel dimensions, graft adaptation, and the healing process will be evaluated radiologically.
Complications and Local Evaluation
Postoperative complications occurring during follow-up will be recorded in detail. These will include infection, tunnel widening, fracture, wound-healing problems, tunnel malposition, graft laxity, recurrent clinical instability, and graft rerupture. All complications will be analyzed together with clinical examination findings and radiological assessments.
Statistical Analysis
All collected data will be analyzed using appropriate statistical methods. The effects of graft type, graft size, graft harvest site, and femoral and tibial tunnel dimensions and positions on return to normal active life and sports, functional recovery, and postoperative clinical outcomes will be evaluated.
In addition, the relationship between the degree of preoperative knee instability and postoperative clinical, functional, and radiological outcomes will be statistically assessed.
Through this methodological approach, the study aims to identify factors associated with postoperative functional outcomes following anterior cruciate ligament reconstruction and to evaluate the influence of graft characteristics and femoral and tibial tunnel placement on clinical success.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing ACL Reconstruction | – | –ACL Reconstruction Cohort |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of patients diagnosed with anterior cruciate ligament (ACL) rupture who are scheduled to undergo primary ACL reconstruction at our institution. Eligible participants will be prospectively enrolled and followed postoperatively for clinical, functional, and radiological outcomes.
Key inclusion criteria (6 listed)
- Patients aged 18-50 years.
- Patients diagnosed with unilateral anterior cruciate ligament (ACL) injury.
- Patients scheduled to undergo primary ACL reconstruction.
- Patients who are willing and able to complete a postoperative follow-up period of at least 6 months.
- Patients with available postoperative radiological assessments, including computed tomography (CT), magnetic resonance imaging (MRI), and/or standard radiographs, as required by the study protocol.
Key exclusion criteria (8 listed)
- Patients with multiligament knee injuries, including clinically significant concomitant posterior cruciate ligament (PCL), medial collateral ligament (MCL), or lateral collateral ligament (LCL) injuries.
- Patients with a history of previous non-ACL surgery on the affected knee.
- Patients with advanced knee osteoarthritis.
- Patients who develop a postoperative infection.
- Patients with insufficient or inadequate radiological imaging data for the planned assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lysholm Knee Score
Time frame: 1 YEAR
Postoperative knee function will be assessed using the Lysholm Knee Score. The score ranges from 0 to 100, with higher scores indicating better knee function. The association between preoperative knee instability measured using the Rolimeter and postoperative Lysholm scores will be evaluated.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score
Time frame: 1 YEAR
Postoperative knee function will be assessed using the IKDC Subjective Knee Evaluation Score. Scores range from 0 to 100, with higher scores indicating better symptoms, function, and sports activity. The relationship between preoperative knee instability and postoperative IKDC scores will be analyzed.
1 secondary outcome
Return to Normal Active Life
Time frame: 1 YEAR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 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.
Sakarya Üniversitesi Eğitim Ve Araştirma Hastanesi
Sakarya, Turkey (Türkiye)
Sakarya Üniversitesi Eğitim Ve Araştirma Hastanesi
Sakarya, Turkey (Türkiye)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injury and Tunneling Technique, run by Sakarya University at 2 sites in Turkey (Türkiye).
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm Knee Score (time frame: 1 YEAR). The study lists 2 primary outcomes in all. 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 15 Oct 2026.