Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233305
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-01-22
Brief Title:
Effect of Physical Therapy andor Platelet Rich Plasma Injection in People With Knee Cruciate Ligament Injuries
Sponsor:
Taipei Hospital Ministry of Health and Welfare
Organization:
Taipei Hospital Ministry of Health and Welfare
Study Overview
Official Title:
Effect of Physical Therapy andor Platelet Rich Plasma Injection in People With Knee Cruciate Ligament Injuries an Observative Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
The anterior cruciate ligamentACL 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 PRPand 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
The anterior cruciate ligamentACL 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 PRPand 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None