Clinical trial NCT04677218: Prospective Clinical Results of 3 Different Femoral Fixation in ACL Reconstruction
Official title: Comparison of Clinical Results of Adjustable Femoral Loop With Three Different Techniques in Patients Who Underwent Arthroscopic ACL Reconstruction With Hamstring Autograft: A Prospective Randomised Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL Injury
Anterior Cruciate Ligament Rupture
Keywords: ACL injury
Adjustable femoral loop
Arthroscopic ACL reconstruction
outcomes
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior cruciate ligament (ACL) tears are one of the most common injuries of the knee. In today's world, due to developing sports industry , the increase in sports traumas of both genders and ages ACL injuries and treatments are given major priority.

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: This study has been planned as a prospective randomized clinical trial. We used a completely computer-generated list in order to randomize all participants to receive one of two treatments (www.random.org/sequences/).

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.

Eligibility criteria: Inclusion Criteria:

* Patients with ACL Rupture between the ages of 18-55
* Patients with isolated + primary ACL rupture only
* Patients with ACL rupture ± meniscal tear

Exclusion Criteria:

* Patients with Posterior cruciate ligament rupture
* Multiligamentous knee injuries
* Patients with Medial or Lateral Collateral injuries
* Patients with previous revision surgeries

Primary outcomes:
measure: Kt-1000 Stability
timeFrame: 12.months postoperatively
measure: Isokinetic Knee tests
timeFrame: 12.months postoperatively
Secondary outcomes:
measure: IKDC scores
timeFrame: 12.months postoperatively
measure: Tegner-Lysolm score
timeFrame: 12.months postoperatively
measure: Postoperative Range of motion
timeFrame: 6.months and 12.months postoperatively
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology
Study officials:
affiliation: Istanbul University Istanbul Medical Faculty
name: Gokhan Polat, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.
citation: 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.