Anterior Cruciate Ligament InjuriesNCT05579067
Comparative Evaluation of Functional Results and Survival Rate of Peroneus Longus Tendon - PLT and Hamstring Tendon - HT Used for Reconstruction of the Anterior Cruciate Ligament.
A study testing ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice. and ACL Reconstruction using an autograph of Hamstrings muscle tendons. in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by eMKa MED Medical Center at 1 site in Poland.
Trial summary
Comparative evaluation of functional results and survival rate of peroneus longus tendon - PLT and hamstring tendon - HT used for reconstruction of the anterior cruciate ligament. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- What is being tested?
- ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice. and ACL Reconstruction using an autograph of Hamstrings muscle tendons.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 2 Feb 2022to 9 Feb 2024
- Phase
- Interventional
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years;
- Surgery for ACL damage to the knee joint;
- Arthroscopic surgery;
- No prior knee surgical interventions;
- No additional pathologies in this anatomical area;
- Patient informed consent to participate in research.
Who cannot join
- Age under 18 or over 65;
- Previous surgical interventions in the examined anatomical area;
- Additional pathologies in this area identified as part of preoperative diagnostics;
- Damage to the second knee joint;
- Failure to comply with the rigor of the same rehabilitation treatment protocol.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
eMKa MED Medical Center
Wroclaw, Dolnośląsk, 53-110
Maciej Kentel, MD, +48518744908, emkamed.cm@gmail.com
Kacper Kentel, master's degree, +48695263711, kacper.kentel@emkamed.com.pl
About this study
Comparative evaluation of functional results and survival rate of peroneus longus tendon - PLT and hamstring tendon - HT used for reconstruction of the anterior cruciate ligament.
Read the detailed description
Comparison of treatment results - survival and reconstruction of autographs and functional results of the knee joint, and functional results of the ankle joint, obtained in the study groups operated using two methods:
A- the use of a long fibular tendon autograft taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint; B- the use of Hamstring muscle tendon autograft (Semitendonus and slender muscle) taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint.
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Knee Injuries, Knee Ligament Injury
- Being tested
- ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice., ACL Reconstruction using an autograph of Hamstrings muscle tendons.
- Keywords
- Injuries, Rupture, Tear, ACL, Reconstruction, Techniques
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries, Wounds and Injuries, Rupture, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice.Procedure or surgery
The use of a peroneus longus tendon autograft taken from the lower leg of the same limb and used as a graft to reconstruct the ACL (anterior cruciate ligament) of the knee joint.
ACL Reconstruction using an autograph of Hamstrings muscle tendons.Procedure or surgery
The use of Hamstring muscle tendon autograft (Semitendinus and slender muscle) taken from the lower leg of the same limb and used as a graft to reconstruct the ACL (anterior cruciate ligament) of the knee joint.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of functional results and survival rate of peroneus longus tendon used for ACLR. | Experimental | Not described Receives: Procedure: ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice. |
| Evaluation of functional results and survival rate of hamstring tendon used for ACL reconstruction. | Active comparator | Not described Receives: Procedure: ACL Reconstruction using an autograph of Hamstrings muscle tendons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Score (VAS)
Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of:
- 0 to 4 mm can be considered no pain;
- 5 to 44 mm, mild pain;
- 45 to 74 mm, moderate pain;
- 75 to 100 mm, severe pain.
Measured: 1 day
Visual Analogue Score (VAS)
Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of:
- 0 to 4 mm can be considered no pain;
- 5 to 44 mm, mild pain;
- 45 to 74 mm, moderate pain;
- 75 to 100 mm, severe pain.
Measured: 3 months after procedure
Visual Analogue Score (VAS)
Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of:
- 0 to 4 mm can be considered no pain;
- 5 to 44 mm, mild pain;
- 45 to 74 mm, moderate pain;
- 75 to 100 mm, severe pain.
Measured: 6 months after procedure
Tegner Activity Level Scale (TAS)
The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale.
The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Measured: 1 day
Tegner Activity Level Scale (TAS)
The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale.
The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Measured: 3 months after procedure
Tegner Activity Level Scale (TAS)
The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale.
The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Measured: 6 months after procedure
IKDC SUBJECTIVE KNEE EVALUATION FORM
Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.
Measured: 1 day
IKDC SUBJECTIVE KNEE EVALUATION FORM
Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.
Measured: 3 months after procedure
IKDC SUBJECTIVE KNEE EVALUATION FORM
Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.
Measured: 6 months after procedure
Tegner Lysholm Knee Scoring Scale
The Tegner Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Grading the Tegner Lysholm Knee Scoring Scale:
- <65 - poor;
- 65-83 - fair;
- 84-90 - good;
- >90 - excellent.
Measured: 1 day
Tegner Lysholm Knee Scoring Scale
The Tegner Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Grading the Tegner Lysholm Knee Scoring Scale:
- <65 - poor;
- 65-83 - fair;
- 84-90 - good;
- >90 - excellent.
Measured: 3 months after procedure
Tegner Lysholm Knee Scoring Scale
The Tegner Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Grading the Tegner Lysholm Knee Scoring Scale:
- <65 - poor;
- 65-83 - fair;
- 84-90 - good;
- >90 - excellent.
Measured: 6 months after procedure
Body Mass Index (BMI)
BMI is interpreted using standard weight status categories:
I : below 18.5 kg/m2 - underweight;
II : 18.5 - 24.9 kg/m2 - healthy weight;
III : 25.0 - 29.9 kg/m2 - overweight;
IV : 30.0 kg/m2 and above - obesity.
Measured: 1 day
Body Mass Index (BMI)
BMI is interpreted using standard weight status categories:
I : below 18.5 kg/m2 - underweight;
II : 18.5 - 24.9 kg/m2 - healthy weight;
III : 25.0 - 29.9 kg/m2 - overweight;
IV : 30.0 kg/m2 and above - obesity.
Measured: 3 months after procedure
Body Mass Index (BMI)
BMI is interpreted using standard weight status categories:
I : below 18.5 kg/m2 - underweight;
II : 18.5 - 24.9 kg/m2 - healthy weight;
III : 25.0 - 29.9 kg/m2 - overweight;
IV : 30.0 kg/m2 and above - obesity.
Measured: 6 months after procedure
The American Orthopedic Foot and Ankle Score (AOFAS)
is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion.each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. Scores range from 0 to 100, with healthy ankles receiving 100 points.
Measured: 1 day
The American Orthopedic Foot and Ankle Score (AOFAS)
is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion.each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. Scores range from 0 to 100, with healthy ankles receiving 100 points.
Measured: 3 month after procedure
The American Orthopedic Foot and Ankle Score (AOFAS)
is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion.each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. Scores range from 0 to 100, with healthy ankles receiving 100 points.
Measured: 6 month after procedure
Biomechanical examination
On the Biodex 3 System measuring device
Measured: 3 months after procedure
Biomechanical examination
On the Biodex 3 System measuring device
Measured: 6 months after procedure
Ultrasonography (USG)
Ultrasound examination on the apparatus with the option of elastometry
Measured: 6 months after procedure
Magnetic resonance imaging (MRI)
1,5 Tesli
Measured: 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start2 Feb 2022
- Primary completion2 Feb 2024 (estimated)
- Study completion9 Feb 2024 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A- the use of a peroneus longus tendon autograft taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint; B- the use of Hamstring muscle tendon autograft (Semitendonus and slender muscle) taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- eMKa MED Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579067
- Sponsor's protocol ID
- KB-84/2022
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2022
- Last updated
- 13 Oct 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 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Functional Results and Survival Rate of Peroneus Longus Tendon - PLT and Hamstring Tendon - HT Used for Reconstruction of the Anterior Cruciate Ligament.
- ClinicalTrials.gov ID
- NCT05579067
- Acronym / sponsor ID
- KB-84/2022
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Knee Injuries, Knee Ligament Injury
- Keywords
- Injuries, Rupture, Tear, ACL, Reconstruction, Techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- eMKa MED Medical CenterUniversity, hospital or other
- Collaborators
- Wroclaw Medical University
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 2 Feb 2024 (estimated)
- Study completion
- 9 Feb 2024 (estimated)
- First posted
- 13 Oct 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.
Comparative evaluation of functional results and survival rate of peroneus longus tendon - PLT and hamstring tendon - HT used for reconstruction of the anterior cruciate ligament.
Detailed description
Comparison of treatment results - survival and reconstruction of autographs and functional results of the knee joint, and functional results of the ankle joint, obtained in the study groups operated using two methods:
A- the use of a long fibular tendon autograft taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint; B- the use of Hamstring muscle tendon autograft (Semitendonus and slender muscle) taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A- the use of a peroneus longus tendon autograft taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint; B- the use of Hamstring muscle tendon autograft (Semitendonus and slender muscle) taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint
| Arm | Type | Receives |
|---|---|---|
| Evaluation of functional results and survival rate of peroneus longus tendon used for ACLR. | Experimental | Procedure: ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice. |
| Evaluation of functional results and survival rate of hamstring tendon used for ACL reconstruction. | Active comparator | Procedure: ACL Reconstruction using an autograph of Hamstrings muscle tendons. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65 years;
- Surgery for ACL damage to the knee joint;
- Arthroscopic surgery;
- No prior knee surgical interventions;
- No additional pathologies in this anatomical area;
Key exclusion criteria (5 listed)
- Age under 18 or over 65;
- Previous surgical interventions in the examined anatomical area;
- Additional pathologies in this area identified as part of preoperative diagnostics;
- Damage to the second knee joint;
- Failure to comply with the rigor of the same rehabilitation treatment protocol.
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 |
|---|---|---|
| ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice.The use of a peroneus longus tendon autograft taken from the lower leg of the same limb and used as a graft to reconstruct the ACL (anterior cruciate ligament) of the knee joint. | Procedure or surgery | Evaluation of functional results and survival rate of peroneus longus tendon used for ACLR. |
| ACL Reconstruction using an autograph of Hamstrings muscle tendons.The use of Hamstring muscle tendon autograft (Semitendinus and slender muscle) taken from the lower leg of the same limb and used as a graft to reconstruct the ACL (anterior cruciate ligament) of the knee joint. | Procedure or surgery | Evaluation of functional results and survival rate of hamstring tendon used for ACL reconstruction. |
Primary outcome
Visual Analogue Score (VAS)
Time frame: 1 day
Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of: * 0 to 4 mm can be considered no pain; * 5 to 44 mm, mild pain; * 45 to 74 mm, moderate pain; * 75 to 100 mm, severe pain.
Visual Analogue Score (VAS)
Time frame: 3 months after procedure
Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of: * 0 to 4 mm can be considered no pain; * 5 to 44 mm, mild pain; * 45 to 74 mm, moderate pain; * 75 to 100 mm, severe pain.
Visual Analogue Score (VAS)
Time frame: 6 months after procedure
Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of: * 0 to 4 mm can be considered no pain; * 5 to 44 mm, mild pain; * 45 to 74 mm, moderate pain; * 75 to 100 mm, severe pain.
Tegner Activity Level Scale (TAS)
Time frame: 1 day
The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Tegner Activity Level Scale (TAS)
Time frame: 3 months after procedure
The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Tegner Activity Level Scale (TAS)
Time frame: 6 months after procedure
The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
IKDC SUBJECTIVE KNEE EVALUATION FORM
Time frame: 1 day
Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.
IKDC SUBJECTIVE KNEE EVALUATION FORM
Time frame: 3 months after procedure
Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.
IKDC SUBJECTIVE KNEE EVALUATION FORM
Time frame: 6 months after procedure
Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.
Tegner Lysholm Knee Scoring Scale
Time frame: 1 day
The Tegner Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). Grading the Tegner Lysholm Knee Scoring Scale: * <65 - poor; * 65-83 - fair; * 84-90 - good; * >90 - excellent.
Tegner Lysholm Knee Scoring Scale
Time frame: 3 months after procedure
The Tegner Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). Grading the Tegner Lysholm Knee Scoring Scale: * <65 - poor; * 65-83 - fair; * 84-90 - good; * >90 - excellent.
Tegner Lysholm Knee Scoring Scale
Time frame: 6 months after procedure
The Tegner Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). Grading the Tegner Lysholm Knee Scoring Scale: * <65 - poor; * 65-83 - fair; * 84-90 - good; * >90 - excellent.
Body Mass Index (BMI)
Time frame: 1 day
BMI is interpreted using standard weight status categories: I : below 18.5 kg/m2 - underweight; II : 18.5 - 24.9 kg/m2 - healthy weight; III : 25.0 - 29.9 kg/m2 - overweight; IV : 30.0 kg/m2 and above - obesity.
Body Mass Index (BMI)
Time frame: 3 months after procedure
BMI is interpreted using standard weight status categories: I : below 18.5 kg/m2 - underweight; II : 18.5 - 24.9 kg/m2 - healthy weight; III : 25.0 - 29.9 kg/m2 - overweight; IV : 30.0 kg/m2 and above - obesity.
Body Mass Index (BMI)
Time frame: 6 months after procedure
BMI is interpreted using standard weight status categories: I : below 18.5 kg/m2 - underweight; II : 18.5 - 24.9 kg/m2 - healthy weight; III : 25.0 - 29.9 kg/m2 - overweight; IV : 30.0 kg/m2 and above - obesity.
The American Orthopedic Foot and Ankle Score (AOFAS)
Time frame: 1 day
is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion.each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. Scores range from 0 to 100, with healthy ankles receiving 100 points.
The American Orthopedic Foot and Ankle Score (AOFAS)
Time frame: 3 month after procedure
is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion.each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. Scores range from 0 to 100, with healthy ankles receiving 100 points.
The American Orthopedic Foot and Ankle Score (AOFAS)
Time frame: 6 month after procedure
is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion.each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. Scores range from 0 to 100, with healthy ankles receiving 100 points.
Biomechanical examination
Time frame: 3 months after procedure
On the Biodex 3 System measuring device
Biomechanical examination
Time frame: 6 months after procedure
On the Biodex 3 System measuring device
Ultrasonography (USG)
Time frame: 6 months after procedure
Ultrasound examination on the apparatus with the option of elastometry
Magnetic resonance imaging (MRI)
Time frame: 6 months after procedure
1,5 Tesli
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice. and ACL Reconstruction using an autograph of Hamstrings muscle tendons. in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by eMKa MED Medical Center at 1 site in Poland.
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 6 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 13 Oct 2022. 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 Poland. 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 Maciej Kentel, MD PhD (+48518744908, emkamed.cm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score (VAS) (time frame: 1 day). The study lists 22 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 13 Oct 2022.