Clinical trial NCT06233305: Effect of Physical Therapy and/or Platelet Rich Plasma Injection in People With Knee Cruciate Ligament Injuries
Official title: Effect of Physical Therapy and/or Platelet Rich Plasma Injection in People With Knee Cruciate Ligament Injuries: an Observative Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Cruciate Ligament Tear
Posterior Cruciate Ligament Tear
Keywords: PRP
Therapeutic exercise
Modality physical therapy
Lead sponsor: Taipei Hospital, Ministry of Health and Welfare
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Balance Sensing Test
timeFrame: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
measure: Gait Analysis
timeFrame: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
measure: Time up and go test
timeFrame: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
measure: Muscle Strength Test
timeFrame: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
measure: International Knee Documentation Committee
timeFrame: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
measure: Ligament elasticity
timeFrame: Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Hospital, Ministry of Health and Welfare
Study officials:
References: