Anterior Cruciate Ligament TearNCT06233305
Effect of Physical Therapy and/or Platelet Rich Plasma Injection in People With Knee Cruciate Ligament Injuries
An observational study of Anterior Cruciate Ligament Tear and Posterior Cruciate Ligament Tear, run by Taipei Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
Trial summary
Background: The anterior cruciate ligament(ACL) , one of the major ligaments in the knee joint which connects the posterior aspect of the lateral femoral condyle to the anterior intercondylar area of the tibia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anterior Cruciate Ligament Tear, Posterior Cruciate Ligament Tear
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jan 2024to 27 Mar 2025
- 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 80 years
- All sexes
- Adult, Older adult
Study population: The study subjects were sampled from the Rehabilitation Department of the Taipei Hospital, Ministry of Health and Welfare, with an anticipated enrollment of 40 individuals with anterior cruciate ligament (ACL) knee injuries
Who may be able to join
- Age between 18 to 80 years old.
- Magnetic Resonance Imaging (MRI) shows partial tearing of the anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL), possibly combined with injuries to the medial collateral ligament (MCL) or meniscus.
- No surgical treatment has been undergone.
Who cannot join
- Had knee joint diseases or undergone knee joint surgery before the injury.
- Surgical intervention is required for severe damage to knee joint ligaments, meniscus, or articular tissues, such as complete rupture of lateral ligaments or full-thickness cartilage injuries.
- Suffers from diseases affecting physical activity function, such as stroke or nerve damage.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, 24213
Huan-Jui Yeh, Doctor, 886＋978079519, yetil102@hotmail.com
Fang-Ting Liu, 886+960305620, ltim712@gmail.com
About this study
Official title: Effect of Physical Therapy and/or Platelet Rich Plasma Injection in People With Knee Cruciate Ligament Injuries: an Observative Study
Background:
The anterior cruciate ligament(ACL) , one of the major ligaments in the knee joint which connects the posterior aspect of the lateral femoral condyle to the anterior intercondylar area of the tibia. It plays a crucial role in maintaining knee joint stability, preventing excessive rotation of the tibia, and controlling the angles of knee valgus and varus. Additionally, the ACL contains mechanoreceptors that contribute to proprioception input. Acute ACL injuries are characterized by joint effusion, instability, and reduced range of motion. In the chronic phase, instability and pain may occur during rotational and cutting movements.
Read more
Currently, regenerative injection therapies such as high-concentration platelet-rich plasma (PRP)and bone marrow concentrate (BMC) are being explored for ACL repair. Studies have found that postoperative administration of high-concentration PRP significantly reduces pain and improves knee joint function for a duration of 3 to 6 months, but these effects are not sustained beyond 12 months. In addition, some research indicates that high-concentration PRP does not enhance graft healing or improve knee joint stability.
Method:
This is a single-institution, single-blind, observational study conducted by the rehabilitation department of a public hospital. The study aims to recruit 40 participants with anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) injuries. The treatment intervention is collaboratively determined by the physician and the participant during the clinic visit. Subsequently, a therapist, unaware of the treatment details, conducts baseline assessments, including basic information collection, balance testing, gait analysis, timed up and go test, muscle strength evaluation, and subjective knee assessment questionnaire. Additionally, a physician, blinded to the treatment content, employs ultrasound to assess ligament elasticity. Follow-up assessments are conducted for the same parameters two months later.
- Keywords
- PRP, Therapeutic exercise, Modality physical therapy
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Sensing Test
Subjects were instructed to wear knee protectors(KNEESUP Care ) equipped with 3D gyroscopes which made from Conzion and subjects were asked to perform three trials of open-eye single-leg standing and three trials of closed-eye single-leg standing. The dynamic sensing system software recorded the time spent in single-leg standing and analyzed parameters such as balance area, anterior-posterior and medial-lateral displacement of the knee joint, and differences between the two feet.
Measured: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Gait Analysis
Subjects were instructed to wear knee protectors(KNEESUP Care ) equipped with 3D gyroscopes which made from Conzion. Gait analysis involves having the subjects walk back and forth for six meters while wearing the device, with the software analyzing differences in the gait of both feet.
Measured: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Time up and go test
Subjects were instructed to wear knee protectors(KNEESUP Care ) equipped with 3D gyroscopes which made from Conzion. The patient stand up from the chair, walking three meters forward, turn around, and return to the chair to sit down.The KNEESUP will calculate the total time needed
Measured: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Muscle Strength Test
Quantify muscle strength of knee extensors and knee flexors using a hand-held dynamometer(ISOFROCE GT-300) which made from OG WELLNESS
Measured: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
International Knee Documentation Committee
A total of 18 items were assessed, covering aspects such as symptoms, physical activity, and functionality. Each item was scored on a sequential scale, with higher scores indicating lower symptoms and higher functionality. The sum of all scores was calculated and then converted into a scale ranging from 0 to 100.
Measured: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Ligament elasticity
Utilizing shear wave elastography, elastic images are generated by inducing shear waves within the tissue using acoustic pressure waves. The propagation speed of these waves is directly proportional to the square root of the tissue's elastic modulus. The elasticity coefficient of the anterior cruciate ligament is measured in patients at various degrees of knee flexion.
Measured: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start3 Jan 2024
- Primary completion27 Dec 2024 (estimated)
- Study completion27 Mar 2025 (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 TearStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Hospital, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233305
- Sponsor's protocol ID
- 202414
- Status last verified
- Mar 2024
- First submitted
- 22 Jan 2024
- Last updated
- 5 Mar 2024
- Results posted
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Therapy and/or Platelet Rich Plasma Injection in People With Knee Cruciate Ligament Injuries: an Observative Study
- ClinicalTrials.gov ID
- NCT06233305
- Acronym / sponsor ID
- 202414
- Keywords
- PRP, Therapeutic exercise, Modality physical therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Hospital, Ministry of Health and WelfareUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 27 Dec 2024 (estimated)
- Study completion
- 27 Mar 2025 (estimated)
- First posted
- 31 Jan 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.
Background:
The anterior cruciate ligament(ACL) , one of the major ligaments in the knee joint which connects the posterior aspect of the lateral femoral condyle to the anterior intercondylar area of the tibia. It plays a crucial role in maintaining knee joint stability, preventing excessive rotation of the tibia, and controlling the angles of knee valgus and varus. Additionally, the ACL contains mechanoreceptors that contribute to proprioception input. Acute ACL injuries are characterized by joint effusion, instability, and reduced range of motion. In the chronic phase, instability and pain may occur during rotational and cutting movements.
Currently, regenerative injection therapies such as high-concentration platelet-rich plasma (PRP)and bone marrow concentrate (BMC) are being explored for ACL repair. Studies have found that postoperative administration of high-concentration PRP significantly reduces pain and improves knee joint function for a duration of 3 to 6 months, but these effects are not sustained beyond 12 months. In addition, some research indicates that high-concentration PRP does not enhance graft healing or improve knee joint stability.
Method:
This is a single-institution, single-blind, observational study conducted by the rehabilitation department of a public hospital. The study aims to recruit 40 participants with anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) injuries. The treatment intervention is collaboratively determined by the physician and the participant during the clinic visit. Subsequently, a therapist, unaware of the treatment details, conducts baseline assessments, including basic information collection, balance testing, gait analysis, timed up and go test, muscle strength evaluation, and subjective knee assessment questionnaire. Additionally, a physician, blinded to the treatment content, employs ultrasound to assess ligament elasticity. Follow-up assessments are conducted for the same parameters two months later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study subjects were sampled from the Rehabilitation Department of the Taipei Hospital, Ministry of Health and Welfare, with an anticipated enrollment of 40 individuals with anterior cruciate ligament (ACL) knee injuries
Key inclusion criteria (3 listed)
- Age between 18 to 80 years old.
- Magnetic Resonance Imaging (MRI) shows partial tearing of the anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL), possibly combined with injuries to the medial collateral ligament (MCL) or meniscus.
- No surgical treatment has been undergone.
Key exclusion criteria (3 listed)
- Had knee joint diseases or undergone knee joint surgery before the injury.
- Surgical intervention is required for severe damage to knee joint ligaments, meniscus, or articular tissues, such as complete rupture of lateral ligaments or full-thickness cartilage injuries.
- Suffers from diseases affecting physical activity function, such as stroke or nerve damage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Balance Sensing Test
Time frame: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Subjects were instructed to wear knee protectors(KNEESUP Care ) equipped with 3D gyroscopes which made from Conzion and subjects were asked to perform three trials of open-eye single-leg standing and three trials of closed-eye single-leg standing. The dynamic sensing system software recorded the time spent in single-leg standing and analyzed parameters such as balance area, anterior-posterior and medial-lateral displacement of the knee joint, and differences between the two feet.
Gait Analysis
Time frame: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Subjects were instructed to wear knee protectors(KNEESUP Care ) equipped with 3D gyroscopes which made from Conzion. Gait analysis involves having the subjects walk back and forth for six meters while wearing the device, with the software analyzing differences in the gait of both feet.
Time up and go test
Time frame: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Subjects were instructed to wear knee protectors(KNEESUP Care ) equipped with 3D gyroscopes which made from Conzion. The patient stand up from the chair, walking three meters forward, turn around, and return to the chair to sit down.The KNEESUP will calculate the total time needed
Muscle Strength Test
Time frame: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Quantify muscle strength of knee extensors and knee flexors using a hand-held dynamometer(ISOFROCE GT-300) which made from OG WELLNESS
International Knee Documentation Committee
Time frame: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
A total of 18 items were assessed, covering aspects such as symptoms, physical activity, and functionality. Each item was scored on a sequential scale, with higher scores indicating lower symptoms and higher functionality. The sum of all scores was calculated and then converted into a scale ranging from 0 to 100.
Ligament elasticity
Time frame: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Utilizing shear wave elastography, elastic images are generated by inducing shear waves within the tissue using acoustic pressure waves. The propagation speed of these waves is directly proportional to the square root of the tissue's elastic modulus. The elasticity coefficient of the anterior cruciate ligament is measured in patients at various degrees of knee flexion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- 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.
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan
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 Tear and Posterior Cruciate Ligament Tear, run by Taipei Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
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 3 inclusion and 3 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 5 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Sensing Test (time frame: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.). The study lists 6 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 5 Mar 2024.