Anterior Cruciate Ligament RuptureNCT06190223
Anterior Cruciate Ligament Reconstruction With a Periosteal - Patellar Tendon - Bone Autograft - The Kocabey Press-Fit Technique
An observational study of Anterior Cruciate Ligament Rupture, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the clinical and radiological outcomes of patients undergoing anatomical single-bundle anterior cruciate ligament reconstruction with periosteal-patellar tendon-bone autograft and press-fit tibial fixation technique. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Anterior cruciate ligament (ACL) reconstruction with a periost-patellar-tendon-bone (PPTB) autograft and a tibial press-fit technique
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Nov 2023to 25 Nov 2025
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: All patients with a diagnosis of ruptured ACL scheduled for surgery with the aforementioned technique.
Who may be able to join
- patients who underwent anatomical single-bundle anterior cruciate ligament reconstruction with periosteal - patellar tendon - bone autograft and press-fit tibial fixation technique after anterior cruciate ligament rupture
- patients with at least 1 year of clinical and radiological follow-up
- patients who did not undergo a revision
Who cannot join
- Patients who underwent a secondary arthroscopy for any reason after primary surgery
- Patients with a history of septic arthritis (before and after the surgery)
- Those with a history of trauma after primary surgery to the operated knee
- Patients who have not completed at least 1 year of follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Ankara
Enejd Veizi, dr.nad89@hotmail.com
About this study
Official title: Anatomic Single Bundle Anterior Cruciate Ligament Reconstruction With a Press-fit Tibial Fixation Technique Using Periosteal - Patellar Tendon - Bone Autograft
This study aims to evaluate the clinical and radiological outcomes of patients undergoing anatomical single-bundle anterior cruciate ligament reconstruction with periosteal-patellar tendon-bone autograft and press-fit tibial fixation technique. The study also aims to compare these outcomes with other reconstruction techniques in the literature. The research investigates the results of a novel surgical technique, providing a minimally invasive and faster rehabilitation for patients undergoing surgery due to anterior cruciate ligament rupture. The technique does not use any screws or staples for tibial fixation, but it carries similar risks as existing techniques. The technique, similar to the well-known bone-patellar tendon-bone (BPTB) autograft technique, creates minimal bone defect at the tibial tuberosity. Over time, the defect remodels and causes minimal clinical discomfort. Despite these limitations, the authors expect patients operated with the investigated new technique to experience less postoperative swelling, less pain, faster mobilization, and earlier rehabilitation.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Anterior cruciate ligament (ACL) reconstruction with a periost-patellar-tendon-bone (PPTB) autograft and a tibial press-fit technique
- Keywords
- Anterior cruciate ligament rupture, Press-fit fixation, Patellar tendon graft
- 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.
Anterior cruciate ligament (ACL) reconstruction with a periost-patellar-tendon-bone (PPTB) autograft and a tibial press-fit techniqueProcedure or surgery
A longitudinal incision will be performed starting from the central part of the patella. A ruler will be used to mark a tendon thickness of 10mm from the middle of the patellar tendon. Superiorly, the patellar periosteum will be marked with a length of 30-40mm and a width of 10mm. Inferiorly, the tibial tubercle will be marked in a trapezoidal shape with a length of approximately 35mm, a superior narrow base of 10mm and an inferior wider base of 12mm. After extraction, the superior part of the graft will be prepared with reinforced sutures in a whipstitch pattern, while the bone block will be shaped according to the planned tunnel width. After adequate preparation, the femoral end of the graft will be shuttled in with an adjusted fixation device, while the tibial end will be hammered in with a small mallet, in a press-fit fashion, stopping short of the joint surface, but tensioned appropriately. The femoral adjustable device will then be tensioned to ensure proper graft sitting.
| Study group | Role | What they receive |
|---|---|---|
| PPTB Group | Patients will undergo anterior cruciate ligament reconstruction with the novel PPTB graft and a tibial press-fit technique. Receives: Procedure: Anterior cruciate ligament (ACL) reconstruction with a periost-patellar-tendon-bone (PPTB) autograft and a tibial press-fit technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Knee injury and Osteoarthritis Outcome Score (KOOS)
minimum value:0, maximum value 100, higher values mean better outcome
Measured: Postoperative 1.st year
The International Knee Documentation Committee Score (IKDC)
minimum value:0, maximum value 100, higher values mean better outcome
Measured: Postoperative 1.st year
Tegner-Lysholm Scale
minimum value:0, maximum value 100, higher values mean better outcome
Measured: Postoperative 1.st year
Graft survival
Overall graft survival
Measured: Postoperative 1.st year
Secondary outcomes (1)
Tunnel widening
Tibial and femoral tunnel widening will be measured on direct calibrated Xrays as a distance (in millimeters) and on CT scans taken at the sixth postoperative month. The distance will be measured on the widest point between the sclerotic lines on the Xrays and perpendicular to their longitudinal trajectories.
Measured: Postoperative 1.st year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start23 Nov 2023
- Primary completion25 Nov 2025 (estimated)
- Study completion25 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- Konya City Hospital, Baltalimani Bone Diseases Research and Training Hospital, Ataturk University, Karadeniz Technical University, Ankara Etlik City Hospital, Fatih Sultan Mehmet Training and Research Hospital, Kutahya Health Sciences University
- Responsible party
- Principal investigator, Enejd Veizi, MD, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190223
- Sponsor's protocol ID
- E2-23-5650
- Status last verified
- Jan 2025
- First submitted
- 28 Nov 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akoto R, Muller-Hubenthal J, Balke M, Albers M, Bouillon B, Helm P, Banerjee M, Hoher J. Press-fit fixation using autologous bone in the tibial canal causes less enlargement of bone tunnel diameter in ACL reconstruction--a CT scan analysis three months postoperatively. BMC Musculoskelet Disord. 2015 Aug 19;16:200. doi: 10.1186/s12891-015-0656-5.
PubMed 26285568Barie A, Sprinckstub T, Huber J, Jaber A. Quadriceps tendon vs. patellar tendon autograft for ACL reconstruction using a hardware-free press-fit fixation technique: comparable stability, function and return-to-sport level but less donor site morbidity in athletes after 10 years. Arch Orthop Trauma Surg. 2020 Oct;140(10):1465-1474. doi: 10.1007/s00402-020-03508-1. Epub 2020 Jun 5.
PubMed 32504178Arnold MP, Burger LD, Wirz D, Goepfert B, Hirschmann MT. The biomechanical strength of a hardware-free femoral press-fit method for ACL bone-tendon-bone graft fixation. Knee Surg Sports Traumatol Arthrosc. 2017 Apr;25(4):1234-1240. doi: 10.1007/s00167-015-3960-6. Epub 2016 Jan 7.
PubMed 26744280Haberli J, Heilgemeir M, Valet S, Aiyangar A, Overes T, Henle P, Eggli S. Novel press-fit technique of patellar bone plug in anterior cruciate ligament reconstruction is comparable to interference screw fixation. Arch Orthop Trauma Surg. 2022 Aug;142(8):1963-1970. doi: 10.1007/s00402-021-04137-y. Epub 2021 Aug 30.
PubMed 34462826Kocabey Y, Yildirim C, Erden T, Kaya A. Tibial Press-Fit Fixation Technique in Anterior Cruciate Ligament Reconstruction. Arthrosc Tech. 2023 Apr 24;12(5):e737-e743. doi: 10.1016/j.eats.2023.02.001. eCollection 2023 May.
PubMed 37323777
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomic Single Bundle Anterior Cruciate Ligament Reconstruction With a Press-fit Tibial Fixation Technique Using Periosteal - Patellar Tendon - Bone Autograft
- ClinicalTrials.gov ID
- NCT06190223
- Acronym / sponsor ID
- E2-23-5650
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Anterior cruciate ligament rupture, Press-fit fixation, Patellar tendon graft
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- Konya City Hospital, Baltalimani Bone Diseases Research and Training Hospital, Ataturk University, Karadeniz Technical University, Ankara Etlik City Hospital, Fatih Sultan Mehmet Training and Research Hospital, Kutahya Health Sciences University
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 25 Nov 2025 (estimated)
- Study completion
- 25 Nov 2025 (estimated)
- First posted
- 5 Jan 2024 (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 study aims to evaluate the clinical and radiological outcomes of patients undergoing anatomical single-bundle anterior cruciate ligament reconstruction with periosteal-patellar tendon-bone autograft and press-fit tibial fixation technique. The study also aims to compare these outcomes with other reconstruction techniques in the literature. The research investigates the results of a novel surgical technique, providing a minimally invasive and faster rehabilitation for patients undergoing surgery due to anterior cruciate ligament rupture. The technique does not use any screws or staples for tibial fixation, but it carries similar risks as existing techniques. The technique, similar to the well-known bone-patellar tendon-bone (BPTB) autograft technique, creates minimal bone defect at the tibial tuberosity. Over time, the defect remodels and causes minimal clinical discomfort. Despite these limitations, the authors expect patients operated with the investigated new technique to experience less postoperative swelling, less pain, faster mobilization, and earlier rehabilitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPTB Group | – | Procedure: Anterior cruciate ligament (ACL) reconstruction with a periost-patellar-tendon-bone (PPTB) autograft and a tibial press-fit techniquePatients will undergo anterior cruciate ligament reconstruction with the novel PPTB graft and a tibial press-fit technique. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients with a diagnosis of ruptured ACL scheduled for surgery with the aforementioned technique.
Key inclusion criteria (3 listed)
- patients who underwent anatomical single-bundle anterior cruciate ligament reconstruction with periosteal - patellar tendon - bone autograft and press-fit tibial fixation technique after anterior cruciate ligament rupture
- patients with at least 1 year of clinical and radiological follow-up
- patients who did not undergo a revision
Key exclusion criteria (4 listed)
- Patients who underwent a secondary arthroscopy for any reason after primary surgery
- Patients with a history of septic arthritis (before and after the surgery)
- Those with a history of trauma after primary surgery to the operated knee
- Patients who have not completed at least 1 year of follow-up
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 |
|---|---|---|
| Anterior cruciate ligament (ACL) reconstruction with a periost-patellar-tendon-bone (PPTB) autograft and a tibial press-fit techniqueA longitudinal incision will be performed starting from the central part of the patella. A ruler will be used to mark a tendon thickness of 10mm from the middle of the patellar tendon. Superiorly, the patellar periosteum will be marked with a length of 30-40mm and a width of 10mm. Inferiorly, the tibial tubercle will be marked in a trapezoidal shape with a length of approximately 35mm, a superior narrow base of 10mm and an inferior wider base of 12mm. After extraction, the superior part of the graft will be prepared with reinforced sutures in a whipstitch pattern, while the bone block will be shaped according to the planned tunnel width. After adequate preparation, the femoral end of the graft will be shuttled in with an adjusted fixation device, while the tibial end will be hammered in with a small mallet, in a press-fit fashion, stopping short of the joint surface, but tensioned appropriately. The femoral adjustable device will then be tensioned to ensure proper graft sitting. | Procedure or surgery | PPTB Group |
Primary outcome
The Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Postoperative 1.st year
minimum value:0, maximum value 100, higher values mean better outcome
The International Knee Documentation Committee Score (IKDC)
Time frame: Postoperative 1.st year
minimum value:0, maximum value 100, higher values mean better outcome
Tegner-Lysholm Scale
Time frame: Postoperative 1.st year
minimum value:0, maximum value 100, higher values mean better outcome
Graft survival
Time frame: Postoperative 1.st year
Overall graft survival
1 secondary outcome
Tunnel widening
Time frame: Postoperative 1.st 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 29 Jan 2025.
- Background: PubMed 26285568Akoto R, Muller-Hubenthal J, Balke M, Albers M, Bouillon B, Helm P, Banerjee M, Hoher J. Press-fit fixation using autologous bone in the tibial canal causes less enlargement of bone tunnel diameter in ACL reconstruction--a CT scan analysis three months postoperatively. BMC Musculoskelet Disord. 2015 Aug 19;16:200. doi: 10.1186/s12891-015-0656-5.
- Background: PubMed 32504178Barie A, Sprinckstub T, Huber J, Jaber A. Quadriceps tendon vs. patellar tendon autograft for ACL reconstruction using a hardware-free press-fit fixation technique: comparable stability, function and return-to-sport level but less donor site morbidity in athletes after 10 years. Arch Orthop Trauma Surg. 2020 Oct;140(10):1465-1474. doi: 10.1007/s00402-020-03508-1. Epub 2020 Jun 5.
- Background: PubMed 26744280Arnold MP, Burger LD, Wirz D, Goepfert B, Hirschmann MT. The biomechanical strength of a hardware-free femoral press-fit method for ACL bone-tendon-bone graft fixation. Knee Surg Sports Traumatol Arthrosc. 2017 Apr;25(4):1234-1240. doi: 10.1007/s00167-015-3960-6. Epub 2016 Jan 7.
- Background: PubMed 34462826Haberli J, Heilgemeir M, Valet S, Aiyangar A, Overes T, Henle P, Eggli S. Novel press-fit technique of patellar bone plug in anterior cruciate ligament reconstruction is comparable to interference screw fixation. Arch Orthop Trauma Surg. 2022 Aug;142(8):1963-1970. doi: 10.1007/s00402-021-04137-y. Epub 2021 Aug 30.
- Background: PubMed 37323777Kocabey Y, Yildirim C, Erden T, Kaya A. Tibial Press-Fit Fixation Technique in Anterior Cruciate Ligament Reconstruction. Arthrosc Tech. 2023 Apr 24;12(5):e737-e743. doi: 10.1016/j.eats.2023.02.001. eCollection 2023 May.
- Individual participant dataSharing planned: Undecided
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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.
1 site 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 Rupture, run by Ankara City Hospital Bilkent at 1 site 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 3 inclusion and 4 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 29 Jan 2025. 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 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?
Contact Enejd Veizi, MD (+905439799959, dr.nad89@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Knee injury and Osteoarthritis Outcome Score (KOOS) (time frame: Postoperative 1.st year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06190223, which also lists 5 linked publications.
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 29 Jan 2025.