Effect of Physical Therapy and/or Platelet Rich Plasma Injection in People With Knee Cruciate Ligament Injuries

Anterior Cruciate Ligament Tear Clinical Trial

Official title:

Effect of Physical Therapy and/or Platelet Rich Plasma Injection in People With Knee Cruciate Ligament Injuries: an Observative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233305
• Other study ID #: 202414
• Status: Recruiting
• Start date: January 3, 2024
• Est. completion date: March 27, 2025

Study information

• Verified date: March 2024
• Source: Taipei Hospital, Ministry of Health and Welfare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 27, 2025
• Est. primary completion date: December 27, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age between 18 to 80 years old.

2. 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.

3. No surgical treatment has been undergone.

Exclusion Criteria:

1. Had knee joint diseases or undergone knee joint surgery before the injury.

2. 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.

3. Suffers from diseases affecting physical activity function, such as stroke or nerve damage.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Tear
• Posterior Cruciate Ligament Tear

Locations

Country	Name	City	State
Taiwan	Taipei Hospital, Ministry of Health and Welfare	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Hospital, Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Primary	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.	Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Primary	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	Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Primary	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	Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Primary	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.	Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Primary	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.	Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.