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

NCT ID: NCT06233305

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-03
• Study Completion Date: 2025-03-27

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.

Conditions

Anterior Cruciate Ligament Tear; Posterior Cruciate Ligament Tear

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Hospital, Ministry of Health and Welfare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Hospital, Ministry of Health and Welfare

New Taipei City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Huan-Jui Yeh, Doctor

Role: primary

yetil102@hotmail.com

886＋978079519

Fang-Ting Liu

Role: backup

ltim712@gmail.com

886+960305620

Other Identifiers

202414

Identifier Type: -

Identifier Source: org_study_id