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

March 3, 2024 updated by: Taipei Hospital, Ministry of Health and Welfare

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.

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 24213
        • Recruiting
        • Taipei Hospital, Ministry of Health and Welfare
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
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.
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
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
Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
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
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
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.
Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.
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.
Pre-treatment assessment, approximately one month later perform a mid-term assessment, and two months later, conduct a post-treatment assessment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Hospital, Ministry of Health and Welfare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2024

Primary Completion (Estimated)

December 27, 2024

Study Completion (Estimated)

March 27, 2025

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202414

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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