Anterior Cruciate Ligament InjuriesNCT06319040
The Effect Of Addıtıonal Surgery On Muscle Strength, Proprıoceptıon And Balance In Anterıor Crucıate Lıgament Surgery
An observational study of Anterior Cruciate Ligament Injuries and Meniscus Lesion, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Meniscal tears and RAMP lesions are frequently seen together with ACL injuries. The aim of this study was to evaluate the effects of meniscus repair and RAMP lesion repair ACL reconstruction surgery in terms of muscle strength, proprioception, and balance. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Meniscus Lesion
- What is being tested?
- Muscle strength measurement, Knee joint proprioception and Balance
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2018to 7 Jun 2019
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Our study was conducted with 30 patients who were admitted to Medipol Mega University Hospital between 2018 and 2019 and were diagnosed with ACL rupture and required surgery.
Who may be able to join
- Being between 18 and 40 years of age, not having had any previous knee surgery and not having any diagnosis of knee pathology, not having any musculoskeletal injury, cardiopulmonary or vestibular dysfunction that would prevent performing the tests in the study were the inclusion criteria for control group.
Who cannot join
- In addition to ACL injury, the patients with cartilage damage, knee arthrosis, misalignment in the lower extremity and additional ligament pathologies, history of previous knee surgery, any pathology in the opposite lower extremity, and additional neuromuscular diseases were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Meniscal tears and RAMP lesions are frequently seen together with ACL injuries. The aim of this study was to evaluate the effects of meniscus repair and RAMP lesion repair ACL reconstruction surgery in terms of muscle strength, proprioception, and balance. In our study, the clinical outcomes of both anterior cruciate ligament reconstruction (ACLR), medial meniscus repair (MR) and RAMP lesion repair (RR) have been compared with those of isolated ACLR.
Read the detailed description
Methods:
Fifteen patients of isolated ACLR performed, 15 patients of ACLR with MR or RR performed, and 15 healthy participants were included in our study. Besides, patients to whom ACLR and additional interventions performed divide into subgroups: 7 patients with RR and 8 patients with MR. Isokinetic muscle strength, proprioception, balance, fall risk, Lysholm Knee Scoring and Tegner Activity Level scale of patients were evaluated preoperatively and at the postoperative 6th week.
The data obtained in the research were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Number, percentage, mean, and standard deviation were used as descriptive statistical methods in the evaluation of the data. The relationship between grouped variables was tested by chi-square analysis. One-way Anova test was used to compare quantitative continuous data between more than two independent groups. Scheffe test was used as a complementary post-hoc analysis to determine the differences after the Anova test. The difference between within-group measurements was analyzed with the paired-group t-test.
- Being tested
- Muscle strength measurement, Knee joint proprioception, Balance, Fall risk test, Tegner Activity Level
- Keywords
- ramp lesion, muscle strength, balance, proprioception, ACL
- 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.
Muscle strength measurementOther
Muscle strength of both legs, maximal reciprocal concentric isokinetic knee extension (quadriceps) and flexion (hamstring) at 60°/s, 90°/s and 180°/s speeds were evaluated
Knee joint proprioceptionOther
Knee joint proprioception was assessed by joint position sense. Joint position sense was measured by the previously taught ability to actively find joint position (EPAB)
BalanceOther
The patients and healthy individuals participating in our study were evaluated with the General Stability Index (GSI) for general balance ability, Anterior-Posterior Stability Index (APSI) for anterior-posterior balance ability, Medial-Lateral Stability Index (MLSI) for lateral balance ability and Fall Risk Index (DRI) and Biodex Balance System (Biodex Inc., Shirley, New York, USA) for fall risk. High values obtained indicate deterioration in balance and increased risk of falling.
Fall risk testOther
Biodex Balance System (Biodex Inc., Shirley, New York, USA) for fall risk
Tegner Activity LevelOther
Tegner Activity Level and the Turkish version of the Lysholm Knee Scoring Scale by Çelik et al. were used to subjectively determine the functional level in individuals undergoing ACL reconstruction surgery.
Lysholm Knee Scoring ScaleOther
Tegner Activity Level and the Turkish version of the Lysholm Knee Scoring Scale by Çelik et al. were used to subjectively determine the functional level in individuals undergoing ACL reconstruction surgery.
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | 15 patients who underwent isolated ACLR Receives: Other: Muscle strength measurement; Other: Knee joint proprioception; Other: Balance; Other: Fall risk test; Other: Tegner Activity Level; Other: Lysholm Knee Scoring Scale | |
| Study Group 2 | 15 patients who underwent ACLR with additional intervention Receives: Other: Muscle strength measurement; Other: Knee joint proprioception; Other: Balance; Other: Fall risk test; Other: Tegner Activity Level; Other: Lysholm Knee Scoring Scale | |
| Control Group | 15 healthy individuals Receives: Other: Muscle strength measurement; Other: Knee joint proprioception; Other: Balance; Other: Fall risk test; Other: Tegner Activity Level; Other: Lysholm Knee Scoring Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength measurement
The isokinetic system (Cybex NORM®, Humac, CA, USA) was used to assess muscle strength measurement. Subjects sat upright on the dynamometer chair with 90˚ hip flexion during measurement. The axis of rotation of the dynamometer was adjusted to align with the anatomical axis of the knee joint (lateral condyle of the femur). To prevent compensatory movements during the test, participants were fixed on both shoulders, waist, and thighs. The belt used for the tested extremity was placed 3 cm proximal to the malleolus. Both verbal and visual feedback was given for individuals to participate in the test with maximum effort
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start6 Dec 2018
- Primary completion7 Mar 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Turk Kalkan, Medipol University
- Investigators
- tuğba türk kalkan, MD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319040
- Sponsor's protocol ID
- MEDİPOL MEGA 1
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gulenc B, Kemah B, Yalcin S, Sayar S, Korkmaz O, Erdil M. Surgical Treatment of Meniscal RAMP Lesion. J Knee Surg. 2020 Mar;33(3):255-259. doi: 10.1055/s-0039-1677887. Epub 2019 Mar 8.
PubMed 30849785
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Addıtıonal Surgery On Muscle Strength, Proprıoceptıon And Balance In Anterıor Crucıate Lıgament Surgery
- ClinicalTrials.gov ID
- NCT06319040
- Acronym / sponsor ID
- MEDİPOL MEGA 1
- Keywords
- ramp lesion, muscle strength, balance, proprioception, ACL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 19 Mar 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.
Meniscal tears and RAMP lesions are frequently seen together with ACL injuries. The aim of this study was to evaluate the effects of meniscus repair and RAMP lesion repair ACL reconstruction surgery in terms of muscle strength, proprioception, and balance. In our study, the clinical outcomes of both anterior cruciate ligament reconstruction (ACLR), medial meniscus repair (MR) and RAMP lesion repair (RR) have been compared with those of isolated ACLR.
Detailed description
Methods:
Fifteen patients of isolated ACLR performed, 15 patients of ACLR with MR or RR performed, and 15 healthy participants were included in our study. Besides, patients to whom ACLR and additional interventions performed divide into subgroups: 7 patients with RR and 8 patients with MR. Isokinetic muscle strength, proprioception, balance, fall risk, Lysholm Knee Scoring and Tegner Activity Level scale of patients were evaluated preoperatively and at the postoperative 6th week.
The data obtained in the research were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Number, percentage, mean, and standard deviation were used as descriptive statistical methods in the evaluation of the data. The relationship between grouped variables was tested by chi-square analysis. One-way Anova test was used to compare quantitative continuous data between more than two independent groups. Scheffe test was used as a complementary post-hoc analysis to determine the differences after the Anova test. The difference between within-group measurements was analyzed with the paired-group t-test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | – | Other: Muscle strength measurement, Other: Knee joint proprioception, Other: Balance, Other: Fall risk test, Other: Tegner Activity Level, Other: Lysholm Knee Scoring Scale15 patients who underwent isolated ACLR |
| Study Group 2 | – | Other: Muscle strength measurement, Other: Knee joint proprioception, Other: Balance, Other: Fall risk test, Other: Tegner Activity Level, Other: Lysholm Knee Scoring Scale15 patients who underwent ACLR with additional intervention |
| Control Group | – | Other: Muscle strength measurement, Other: Knee joint proprioception, Other: Balance, Other: Fall risk test, Other: Tegner Activity Level, Other: Lysholm Knee Scoring Scale15 healthy individuals |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Our study was conducted with 30 patients who were admitted to Medipol Mega University Hospital between 2018 and 2019 and were diagnosed with ACL rupture and required surgery.
Key inclusion criteria (1 listed)
- Being between 18 and 40 years of age, not having had any previous knee surgery and not having any diagnosis of knee pathology, not having any musculoskeletal injury, cardiopulmonary or vestibular dysfunction that would prevent performing the tests in the study were the inclusion criteria for control group.
Key exclusion criteria (1 listed)
- In addition to ACL injury, the patients with cartilage damage, knee arthrosis, misalignment in the lower extremity and additional ligament pathologies, history of previous knee surgery, any pathology in the opposite lower extremity, and additional neuromuscular diseases were excluded.
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 |
|---|---|---|
| Muscle strength measurementMuscle strength of both legs, maximal reciprocal concentric isokinetic knee extension (quadriceps) and flexion (hamstring) at 60°/s, 90°/s and 180°/s speeds were evaluated | Other | Control Group, Study Group 1, Study Group 2 |
| Knee joint proprioceptionKnee joint proprioception was assessed by joint position sense. Joint position sense was measured by the previously taught ability to actively find joint position (EPAB) | Other | Control Group, Study Group 1, Study Group 2 |
| BalanceThe patients and healthy individuals participating in our study were evaluated with the General Stability Index (GSI) for general balance ability, Anterior-Posterior Stability Index (APSI) for anterior-posterior balance ability, Medial-Lateral Stability Index (MLSI) for lateral balance ability and Fall Risk Index (DRI) and Biodex Balance System (Biodex Inc., Shirley, New York, USA) for fall risk. High values obtained indicate deterioration in balance and increased risk of falling. | Other | Control Group, Study Group 1, Study Group 2 |
| Fall risk testBiodex Balance System (Biodex Inc., Shirley, New York, USA) for fall risk | Other | Control Group, Study Group 1, Study Group 2 |
| Tegner Activity LevelTegner Activity Level and the Turkish version of the Lysholm Knee Scoring Scale by Çelik et al. were used to subjectively determine the functional level in individuals undergoing ACL reconstruction surgery. | Other | Control Group, Study Group 1, Study Group 2 |
| Lysholm Knee Scoring ScaleTegner Activity Level and the Turkish version of the Lysholm Knee Scoring Scale by Çelik et al. were used to subjectively determine the functional level in individuals undergoing ACL reconstruction surgery. | Other | Control Group, Study Group 1, Study Group 2 |
Primary outcome
muscle strength measurement
Time frame: 30 minutes
The isokinetic system (Cybex NORM®, Humac, CA, USA) was used to assess muscle strength measurement. Subjects sat upright on the dynamometer chair with 90˚ hip flexion during measurement. The axis of rotation of the dynamometer was adjusted to align with the anatomical axis of the knee joint (lateral condyle of the femur). To prevent compensatory movements during the test, participants were fixed on both shoulders, waist, and thighs. The belt used for the tested extremity was placed 3 cm proximal to the malleolus. Both verbal and visual feedback was given for individuals to participate in the test with maximum effort
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 30849785Gulenc B, Kemah B, Yalcin S, Sayar S, Korkmaz O, Erdil M. Surgical Treatment of Meniscal RAMP Lesion. J Knee Surg. 2020 Mar;33(3):255-259. doi: 10.1055/s-0039-1677887. Epub 2019 Mar 8.
- 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. This study is not recruiting at the moment.
tuğba türk kalkan, MD principal investigator
Medipol University
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 Injuries and Meniscus Lesion, run by Medipol University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength measurement (time frame: 30 minutes). 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 NCT06319040, which also lists 1 linked publication.
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 19 Mar 2024.