Prospective Clinical Results of 3 Different Femoral Fixation in ACL Reconstruction
NCT ID: NCT04677218
Last Updated: 2021-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2018-01-15
2021-11-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The success of anterior cruciate ligament (ACL) reconstruction depends on many factors, including the mechanical properties of the graft, positioning of the proper femoral and tibial tunnel, fixation methods and the postoperative rehabilitation.
The tendon grafts can be fixed on the femoral side using several fixation devices, including cortical suspension devices, cross pins, and interference screws. Femoral fixation via Cortical button in a suture loop provides the highest primary stability, and therefore, has become increasingly popular among orthopaedic surgeons. Adjustable and fixed Femoral cortical loops are commonly used for femoral fixation. In this sudy we aimed to compare clinical and functional outcomes of three different techniques of suspensory femoral fixation in ACL reconstruction.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Anterior Cruciate Ligament tear diagnosis will be made by physical examination and magnetic resonance imaging. Participants who agree to be enrolled to study will be examined one day prior to surgery. Patients are randomly divided into 3 groups, after tibial fixation of the hamstring autograft, 3 different techniques will be used in the femoral fixation phase.
The first group will be without knotting and retensioning the graft. In the second group, The graft will be retensioned after tibial fixation. In the third group femoral loop will be retensioned and knotted after tibial fixation.
All the surgeries will be performed by the same senior surgeon experienced in sports medicine surgery under regional anesthesia with patient in supine position.
All participants will receive a standard postoperative rehabilitation program starting immediately after surgery with closed chain exercises and quadriceps strengthening and walking. The operated lower extremity won't be placed in a brace and patient allowed for full weight walking with a pair of crutches.
Postoperative evaluations will be performed regularly at 12 months postoperatively . To assess knee stability, KT-1000 measurement will be applied to both extremities in each group and clinical scores ( lysholm knee score, IKDC ) will be measured.
Furthermore, to evaluate flexor and extensor muscle group around knee, isokinetic tests will be applied to patients in sitting position to analyse peak torque and total work done values.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
First Group
First group of fixation will be standar procedure ( without knotted and retensioned the hamstring autograft after tibial fixation)
No interventions assigned to this group
Second Group
In the second group, the hamstring autograft will be retensioned after tibial fixation.
Arthroscopic ACL reconstruction with retensioned hamstring autograft
After diagnostic arthroscopy, an oblique, 5-cm oblique skin incision is made below the joint line over the proximal edge of the pes anserine.Then fascia will be incised the fascia in an L-shaped fashion. After the releasing the distal end of tendons ,tendons will be harvested in their direction via tendon strippers.During the graft preparation phase firstly femoral tunel will be drilled from AM portal with knee flexed to 120 degrees. The drill will be aligned parallel to the tibial plateau and exit through LFC.Then tibial guide wire will be sent from graft incision to the tibial tunel and drilled for desired direction.Once the adjustable loop button is deployed to the graft, it will be pulled through the tunnels and the button is slipped on lateral femoral cortex. Then tibial fixation will be provided with one bioabsorbable screw and staple.After tibial fixation, the femoral loop will be retensioned in group 2 patients.
Third Group
In the third group, the hamstring autograft will be knotted and retensioned after tibial fixation.
Arthroscopic ACL reconstruction with retensioned and knotted hamstring autograft
After the same preparation procedure as in retensioned autograft group, after tibial fixation of graft, femoral loop will be retensioned and knotted in 3. group .
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Arthroscopic ACL reconstruction with retensioned hamstring autograft
After diagnostic arthroscopy, an oblique, 5-cm oblique skin incision is made below the joint line over the proximal edge of the pes anserine.Then fascia will be incised the fascia in an L-shaped fashion. After the releasing the distal end of tendons ,tendons will be harvested in their direction via tendon strippers.During the graft preparation phase firstly femoral tunel will be drilled from AM portal with knee flexed to 120 degrees. The drill will be aligned parallel to the tibial plateau and exit through LFC.Then tibial guide wire will be sent from graft incision to the tibial tunel and drilled for desired direction.Once the adjustable loop button is deployed to the graft, it will be pulled through the tunnels and the button is slipped on lateral femoral cortex. Then tibial fixation will be provided with one bioabsorbable screw and staple.After tibial fixation, the femoral loop will be retensioned in group 2 patients.
Arthroscopic ACL reconstruction with retensioned and knotted hamstring autograft
After the same preparation procedure as in retensioned autograft group, after tibial fixation of graft, femoral loop will be retensioned and knotted in 3. group .
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with isolated + primary ACL rupture only
* Patients with ACL rupture ± meniscal tear
Exclusion Criteria
* Multiligamentous knee injuries
* Patients with Medial or Lateral Collateral injuries
* Patients with previous revision surgeries
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Emre Kocazeybek
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Emre Kocazeybek
Resident in the orthopedics and Traumatology department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gokhan Polat, M.D
Role: PRINCIPAL_INVESTIGATOR
Istanbul University Istanbul Medical Faculty
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Choi NH, Yang BS, Victoroff BN. Clinical and Radiological Outcomes After Hamstring Anterior Cruciate Ligament Reconstructions: Comparison Between Fixed-Loop and Adjustable-Loop Cortical Suspension Devices. Am J Sports Med. 2017 Mar;45(4):826-831. doi: 10.1177/0363546516674183. Epub 2016 Nov 25.
Ahn HW, Seon JK, Song EK, Park CJ, Lim HA. Comparison of Clinical and Radiologic Outcomes and Second-Look Arthroscopic Findings After Anterior Cruciate Ligament Reconstruction Using Fixed and Adjustable Loop Cortical Suspension Devices. Arthroscopy. 2019 Jun;35(6):1736-1742. doi: 10.1016/j.arthro.2019.01.051. Epub 2019 May 6.
Onggo JR, Nambiar M, Pai V. Fixed- Versus Adjustable-Loop Devices for Femoral Fixation in Anterior Cruciate Ligament Reconstruction: A Systematic Review. Arthroscopy. 2019 Aug;35(8):2484-2498. doi: 10.1016/j.arthro.2019.02.029. Epub 2019 May 27.
Boyle MJ, Vovos TJ, Walker CG, Stabile KJ, Roth JM, Garrett WE Jr. Does adjustable-loop femoral cortical suspension loosen after anterior cruciate ligament reconstruction? A retrospective comparative study. Knee. 2015 Sep;22(4):304-8. doi: 10.1016/j.knee.2015.04.016. Epub 2015 May 19.
Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.
Choi NH, Victoroff BN. Author Reply to "Regarding 'Radiologic and Clinical Outcomes After Hamstring Anterior Cruciate Ligament Reconstruction Using an Adjustable-Loop Cortical Suspension Device With Retensioning and Knot Tying'". Arthroscopy. 2020 Apr;36(4):931-933. doi: 10.1016/j.arthro.2020.01.028. No abstract available.
Related Links
Access external resources that provide additional context or updates about the study.
Web site used for randomization of participants
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
67990154
Identifier Type: -
Identifier Source: org_study_id