Anterior Cruciate Ligament InjuriesNCT05245461
Comparison of Remnant-Preserving Anterior Cruciate Ligament Reconstruction With Healthy Controls
An observational study of Anterior Cruciate Ligament Injuries, run by Acibadem University at 2 sites in Turkey (Türkiye).
Trial summary
Anterior cruciate ligament reconstruction stabilizes the knee joint biomechanically and returns the patients back to the sportive activities. Numerous techniques exist to perform an anterior cruciate ligament reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Assessments
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Adult
Study population: Patients who had remnant-preserving ACL reconstruction and healthy controls
Who may be able to join
- Anatomical single-bundle ACL reconstruction with AM portal technique using hamstring autograft due to full-thickness ACL tear,
- Endobutton technique was used for femoral fixation,
- Not having any trauma or surgery on the opposite knee,
- Patients with a follow-up period of at least 12 months after surgery.
Who cannot join
- Fracture of lower extremity accompanying anterior cruciate ligament tear; posterior cruciate ligament, inner and outer lateral ligament tears,
- Patients who have undergone previous surgery on the knee to be evaluated,
- Cases with repeated anterior cruciate ligament reconstruction,
- Having a history of knee joint arthritis (osteoarthritis, inflammatory arthritis),
- Cases with neurological disease will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Acıbadem Mehmet Ali Aydınlar University
Istanbul
Özgül Öztürk, PhD
- Recruiting
Marmara University
Istanbul
Onur Aydoğdu, PhD
About this study
Official title: Comparison of Patients Who Had Remnant-Preserving Anterior Cruciate Ligament Reconstruction With Healthy Controls In Terms of Muscle Strength and Proprioception
Anterior cruciate ligament reconstruction stabilizes the knee joint biomechanically and returns the patients back to the sportive activities. Numerous techniques exist to perform an anterior cruciate ligament reconstruction surgery. Remnant- preserving reconstruction technique is performed to increase surgery success rates and to accelerate the post-surgical return to sport process. In general, there is no consensus regarding the clinical outcomes of remnant-preserving anterior ligament reconstruction over standart procedure. The purpose of this study is to compare the patients who had remnant-preserving anterior cruciate ligament reconstruction with healthy controls in terms of muscle strength and proprioception.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Assessments
- 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.
AssessmentsOther
Muscle Strength, Proprioception, Kinesiophobia
| Study group | Role | What they receive |
|---|---|---|
| Anterior Cruciate Ligament Reconstruction | Patients who had remnant-preserving anterior cruciate ligament reconstruction Receives: Other: Assessments | |
| Healthy Group | People who had no knee surgery or injury Receives: Other: Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic muscle strength
Isokinetic muscle strength values of the Quadriceps Femoris and Hamstring muscles in the knee joint will be measured using the Biodex® System Pro 4 (Biodex Cor. Shirley NY, USA) device. Subjects will perform a warm-up exercise for the knee joint at 75 pedal cycles per minute for three minutes on a bicycle ergometer prior to testing. After the warm-up exercises, the subjects will be allowed to rest for 10 minutes. Subjects will be seated on the isokinetic device chair with their backs perpendicular to 90º. Concentric isokinetic muscle strength measurements of the affected side and unaffected side quadriceps femoris and hamstring muscles of the subjects will be performed with 5 repetitions at 180º /sec, 240º /sec, 300º /sec after the torso, pelvic and thigh belts are attached. Between tests, subjects will be allowed to rest for one minute each. The peak torque values of the cases will be recorded in Nm.
Measured: 1 day
Proprioception
Biodex® System Pro 4 (Biodex Cor. Shirley NY, USA) device will be used to evaluate the proprioception sensation of the knee joint. The subjects will be asked to sit on the isokinetic dynamometer device with the knee joint in 90º flexion. The sense of proprioception of the operated and non-operated knees will be measured at three different angles of 20º, 50º and 70º. During the test, the target angle will be displayed by the device and the limb will be held in this position for 10 seconds. Then, returning to the starting point, the subject will be asked to actively find the target angle with eyes closed. The scores will be averaged by repeating the measurements three times for each reference angle. A rest period of 3 minutes will be allowed between different reference angles.
Measured: 1 day
Secondary outcomes (1)
Kinesiophobia
The level of fear of movement of the participants will be evaluated with the Tampa Kinesiophobia Scale which is a 17-item scale developed to measure fear of movement/re-injury. The scale includes parameters of injury/re-injury and fear and avoidance in work-related activities. The scale evaluates fear of movement with a 4-point Likert-type scoring system (1= Strongly disagree, 4= Totally agree). While the total score is determined between 17-68, a higher score means that the fear of movement is greater.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Feb 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (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 InjuriesStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital, Marmara University
- Responsible party
- Principal investigator, Özgül Öztürk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245461
- Sponsor's protocol ID
- ATADEK 2021/25
- Status last verified
- Nov 2022
- First submitted
- 6 Feb 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patients Who Had Remnant-Preserving Anterior Cruciate Ligament Reconstruction With Healthy Controls In Terms of Muscle Strength and Proprioception
- ClinicalTrials.gov ID
- NCT05245461
- Acronym / sponsor ID
- ATADEK 2021/25
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital, Marmara University
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 18 Feb 2022 (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 reconstruction stabilizes the knee joint biomechanically and returns the patients back to the sportive activities. Numerous techniques exist to perform an anterior cruciate ligament reconstruction surgery. Remnant- preserving reconstruction technique is performed to increase surgery success rates and to accelerate the post-surgical return to sport process. In general, there is no consensus regarding the clinical outcomes of remnant-preserving anterior ligament reconstruction over standart procedure. The purpose of this study is to compare the patients who had remnant-preserving anterior cruciate ligament reconstruction with healthy controls in terms of muscle strength and proprioception.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Cruciate Ligament Reconstruction | – | Other: AssessmentsPatients who had remnant-preserving anterior cruciate ligament reconstruction |
| Healthy Group | – | Other: AssessmentsPeople who had no knee surgery or injury |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients who had remnant-preserving ACL reconstruction and healthy controls
Key inclusion criteria (4 listed)
- Anatomical single-bundle ACL reconstruction with AM portal technique using hamstring autograft due to full-thickness ACL tear,
- Endobutton technique was used for femoral fixation,
- Not having any trauma or surgery on the opposite knee,
- Patients with a follow-up period of at least 12 months after surgery.
Key exclusion criteria (5 listed)
- Fracture of lower extremity accompanying anterior cruciate ligament tear; posterior cruciate ligament, inner and outer lateral ligament tears,
- Patients who have undergone previous surgery on the knee to be evaluated,
- Cases with repeated anterior cruciate ligament reconstruction,
- Having a history of knee joint arthritis (osteoarthritis, inflammatory arthritis),
- Cases with neurological disease will be excluded from the study.
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 |
|---|---|---|
| AssessmentsMuscle Strength, Proprioception, Kinesiophobia | Other | Anterior Cruciate Ligament Reconstruction, Healthy Group |
Primary outcome
Isokinetic muscle strength
Time frame: 1 day
Isokinetic muscle strength values of the Quadriceps Femoris and Hamstring muscles in the knee joint will be measured using the Biodex® System Pro 4 (Biodex Cor. Shirley NY, USA) device. Subjects will perform a warm-up exercise for the knee joint at 75 pedal cycles per minute for three minutes on a bicycle ergometer prior to testing. After the warm-up exercises, the subjects will be allowed to rest for 10 minutes. Subjects will be seated on the isokinetic device chair with their backs perpendicular to 90º. Concentric isokinetic muscle strength measurements of the affected side and unaffected side quadriceps femoris and hamstring muscles of the subjects will be performed with 5 repetitions at 180º /sec, 240º /sec, 300º /sec after the torso, pelvic and thigh belts are attached. Between tests, subjects will be allowed to rest for one minute each. The peak torque values of the cases will be recorded in Nm.
Proprioception
Time frame: 1 day
Biodex® System Pro 4 (Biodex Cor. Shirley NY, USA) device will be used to evaluate the proprioception sensation of the knee joint. The subjects will be asked to sit on the isokinetic dynamometer device with the knee joint in 90º flexion. The sense of proprioception of the operated and non-operated knees will be measured at three different angles of 20º, 50º and 70º. During the test, the target angle will be displayed by the device and the limb will be held in this position for 10 seconds. Then, returning to the starting point, the subject will be asked to actively find the target angle with eyes closed. The scores will be averaged by repeating the measurements three times for each reference angle. A rest period of 3 minutes will be allowed between different reference angles.
1 secondary outcome
Kinesiophobia
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- 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. This study is not recruiting at the moment.
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 Injuries, run by Acibadem 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özgül Öztürk, PhD (902165004185, ozgul.ozturk@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic muscle strength (time frame: 1 day). 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 14 Nov 2022.