Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04968665
Other study ID # M2019434
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date January 1, 2024

Study information

Verified date July 2021
Source Peking University Third Hospital
Contact Shuang Ren
Phone +8617610252992
Email xixishuang123@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Explore The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration


Description:

Cartilage degeneration in the medial tibiofemoral joint is common after anterior cruciate ligament reconstruction (ACLR), which may develop into knee osteoarthritis (disability rate 21.3%). Alterations in joint biomechanical properties play an important role in cartilage degeneration after ACLR. However, the mechanism remains unclear. Our research studied the joint kinematics and kinetics properties after ACLR and found significant changes in biomechanics in the ACLR knees. Therefore, this study will combine longitude biochemical changes in the cartilage to explore how the alterations in biomechanics would influence biochemical changes in the joint cartilage. This study will explore the joint biomechanical properties during functional activities by motion analysis, the effects of biomechanical properties on cartilage stress distribution by finite element analysis, the long-term biochemical changes in the joint cartilage by functional MRI. This study will establish prediction models for cartilage biomechanical changes in the mid-term based on joint biomechanical properties in the early stage after ACLR, and cartilage biomechanical changes in the long-term based on joint biomechanical properties in the mid-term after ACLR. The study aims to clarify the mechanism of cartilage degeneration after ACLR and search biomechanical risk factors, in order to provide methods for clinical prevention of cartilage degeneration after ACLR.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date January 1, 2024
Est. primary completion date January 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Unilateral ACL rupture of the knee Exclusion Criteria: concomitant with other ligament injury or rupture, with history of surgery or musculoskeletal system injury of the contralateral knee, and the time from injury to operation more than 8 weeks

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
gait testing, functional MRI
diagnostic tests including the gait testing and functional MRI

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary knee T1 rho value knee T1 rho value by functional MRI On the day of enrollment.
Primary knee T1 rho value knee T1 rho value by functional MRI At 6 months post operation.
Primary knee T1 rho value knee T1 rho value by functional MRI At 12 months post operation.
Primary knee T1 rho value knee T1 rho value by functional MRI At 2 years post operation.
Primary knee T2 value knee T1 rho value by functional MRI On the day of enrollment.
Primary knee T2 value knee T1 rho value by functional MRI At 6 months post operation.
Primary knee T2 value knee T1 rho value by functional MRI At 12 months post operation.
Primary knee T2 value knee T1 rho value by functional MRI At 2 years post operation.
Primary knee extension angles Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping On the day of enrollment.
Primary knee extension angles Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping At 6 months post operation.
Primary knee extension angles Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping At 12 months post operation.
Primary knee extension angles Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping At 2 years post operation.
Primary knee moments Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping On the day of enrollment.
Primary knee moments Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping At 6 months post operation.
Primary knee moments Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping At 12 months post operation.
Primary knee moments Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping At 2 years post operation.
Primary ground reaction force Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping On the day of enrollment.
Primary ground reaction force Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping At 6 months post operation.
Primary ground reaction force Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping At 12 months post operation.
Primary ground reaction force Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping At 2 years post operation.
Primary knee rotation angles Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping On the day of enrollment.
Primary knee rotation angles Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping At 6 months post operation.
Primary knee rotation angles Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping At 12 months post operation.
Primary knee rotation angles Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping At 2 years post operation.
See also
  Status Clinical Trial Phase
Recruiting NCT04062578 - Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players N/A
Recruiting NCT05461326 - Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT N/A
Completed NCT05109871 - Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque N/A
Completed NCT05504018 - Clinical and Radiological Evaluation of ACL Reconstruction Results N/A
Recruiting NCT06185231 - Investigation of the Effects of Vibration Therapy on Pain, Functionality, and Proprioception After ACL Injury N/A
Recruiting NCT03968913 - Biologic Therapy to Prevent Osteoarthritis After ACL Injury Early Phase 1
Completed NCT04408690 - Feasibility of a RCT That Compares Immediate Versus Optional Delayed Surgical Repair After ACL Injury Phase 3
Recruiting NCT06222814 - Evaluation of the Results of Two Different Methods in Management of Antero-lateral Instability of the Knee N/A
Recruiting NCT05614297 - Agreement Between Rolimeter and Lachmeter in Patients With ACL Injury
Active, not recruiting NCT05184023 - The Effect of PEMF for Patients With Quadriceps Muscle Weakness After ACLR N/A
Completed NCT04906538 - Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique Phase 2/Phase 3
Completed NCT05014009 - The Influence of Neuromuscular Training on Whole-body Movement Strategies and Knee Mechanics During Change-of-direction Tasks in Sports Science Students N/A
Not yet recruiting NCT06083818 - Anterior Cruciate Ligament Injury Prevention Protocol in Female Football Players With Dynamic Knee Valgus N/A
Recruiting NCT05584020 - Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury N/A
Completed NCT04580290 - Jewel ACL Post Market Clinical Follow Up Study
Recruiting NCT04888052 - Prolonged Preoperative Rehabilitation in ACL Rupture. N/A
Recruiting NCT06430775 - Exploring Prolonged AMR in ACL Reconstructed Patients
Not yet recruiting NCT05580133 - All-Inside Single-Bundle for Anterior Cruciate Ligament Reconstruction With Full Thickness of the Peroneus Longus Tendon Compared to the Six-strand-hamstring Autograft (ACL)
Recruiting NCT04162613 - Can Sensorimotor Function Predict Graft Rupture After ACL Reconstruction
Not yet recruiting NCT05619393 - Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People N/A