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Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique

Primary Purpose

Anterior Cruciate Ligament Tear

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Anterior Cruciate Ligament Reconstruction
Sponsored by
Samsun University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Tear

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who have provided informed written written consent;
  • Patients aged between 18 and 45;
  • Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)
  • Patients undergoing ACL reconstruction with a 8 mm four-strand semitendinosus autograft

Exclusion Criteria:

  • Patients who have not signed informed consent;
  • Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
  • Revision procedures
  • Patients unable to lay still in an MRI or CT scanner
  • Patients with a torn ACL or previous ACL reconstruction in the contralateral knee.
  • Patients who had an excessive tibial slope >12 degrees

Sites / Locations

  • Ahmet E. OkutanRecruiting
  • Samsun UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

All-inside technique

Complete tibial tunnel technique

Arm Description

Both of the femoral and tibial tunnel will be drilled in a retrograde manner using flip-cutter and femoral and tibial sockets will be created. Graft will be passed from the portal. Adjustable suspensory cortical fixation both on tibial and femoral side will be used.

Femoral tunnel will be drilled in an inside-outside manner using standard technique. Then the tibial tunnel will be drilled completely. Graft will be passed from the tibial tunnel. Adjustable suspensory cortical fixation both on the tibial and femoral side will be used.

Outcomes

Primary Outcome Measures

Signal to Noise Quotient
Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation

Secondary Outcome Measures

Difference in Computed Tomography (CT) imaging of Tunnels
Femoral and Tibial Tunnel Morphological Changes
International Knee Documentation Committee (IKDC)
Patient reported outcome measures of symptoms, sports activity & knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
Marx Activity Rating Score
Clinical Outcomes
Side to side difference in anterior tibial translation
Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer

Full Information

First Posted
October 6, 2022
Last Updated
October 28, 2022
Sponsor
Samsun University
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1. Study Identification

Unique Protocol Identification Number
NCT05574946
Brief Title
Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique
Official Title
Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique Using Adjustable Suspensory Fixation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsun University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study intends to perform an all-inside and complete tibial tunnel ACL reconstruction technique in 60 patients, and compare the clinical and radiological outcomes of the two surgical procedures through follow-up.
Detailed Description
This is a prospective randomized, controlled, single-center clinical trial study on ACL reconstruction surgery technique. In this study, 60 patients with ACL rupture were recruited according to the enrollment criteria. The recruited patients were randomly divided into groups. The ratio of the control group is 1:1. In this study, 30 patients with ACL rupture in the experimental group will be treated with all-inside reconstruction technique, and 30 patients with ACL rupture in the control group will be treated with complete tibial tunnel technique. All operations will be performed with 4-strand autologous semitendinosus tendon. All fixations will be performed using an adjustable cortical suspensory system. After reconstruction, all subjects will participate in the collection of clinical function scores including Marx Activity score, IKDC score, and clinical evaluation including physical examination, joint laxity, CT and MRI imaging analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All-inside technique
Arm Type
Experimental
Arm Description
Both of the femoral and tibial tunnel will be drilled in a retrograde manner using flip-cutter and femoral and tibial sockets will be created. Graft will be passed from the portal. Adjustable suspensory cortical fixation both on tibial and femoral side will be used.
Arm Title
Complete tibial tunnel technique
Arm Type
Active Comparator
Arm Description
Femoral tunnel will be drilled in an inside-outside manner using standard technique. Then the tibial tunnel will be drilled completely. Graft will be passed from the tibial tunnel. Adjustable suspensory cortical fixation both on the tibial and femoral side will be used.
Intervention Type
Procedure
Intervention Name(s)
Anterior Cruciate Ligament Reconstruction
Intervention Description
Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft
Primary Outcome Measure Information:
Title
Signal to Noise Quotient
Description
Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Difference in Computed Tomography (CT) imaging of Tunnels
Description
Femoral and Tibial Tunnel Morphological Changes
Time Frame
1 day, 6 months, 1 year
Title
International Knee Documentation Committee (IKDC)
Description
Patient reported outcome measures of symptoms, sports activity & knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
Time Frame
1 year
Title
Marx Activity Rating Score
Description
Clinical Outcomes
Time Frame
1 year
Title
Side to side difference in anterior tibial translation
Description
Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer
Time Frame
6 weeks, 3 months, 6 months, 9 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have provided informed written written consent; Patients aged between 18 and 45; Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL) Patients undergoing ACL reconstruction with a 8 mm four-strand semitendinosus autograft Exclusion Criteria: Patients who have not signed informed consent; Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery Revision procedures Patients unable to lay still in an MRI or CT scanner Patients with a torn ACL or previous ACL reconstruction in the contralateral knee. Patients who had an excessive tibial slope >12 degrees
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmet Emin Okutan, MD
Phone
+905375757657
Email
ahmeteokutan@yahoo.com
Facility Information:
Facility Name
Ahmet E. Okutan
City
Samsun
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmet E. Okutan, M.D.
Facility Name
Samsun University
City
Samsun
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmet Okutan, MD
Email
ahmeteokutan@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34949188
Citation
Bhimani R, Shahriarirad R, Ranjbar K, Erfani A, Ashkani-Esfahani S. Transportal versus all-inside techniques of anterior cruciate ligament reconstruction: a systematic review. J Orthop Surg Res. 2021 Dec 23;16(1):734. doi: 10.1186/s13018-021-02872-x.
Results Reference
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PubMed Identifier
30364847
Citation
Colombet P, Saffarini M, Bouguennec N. Clinical and Functional Outcomes of Anterior Cruciate Ligament Reconstruction at a Minimum of 2 Years Using Adjustable Suspensory Fixation in Both the Femur and Tibia: A Prospective Study. Orthop J Sports Med. 2018 Oct 22;6(10):2325967118804128. doi: 10.1177/2325967118804128. eCollection 2018 Oct.
Results Reference
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Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique

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