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Anterior Cruciate Ligament InjuriesNCT04961736

Ultrasound Evaluation of Hamstring Tendon Regeneration After ACL Reconstruction and Its Influence

An observational study of Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

High incidence rate of knee osteoarthritis and gait analysis are important for early assessment of biomechanics. ACL injury is an ideal clinical model for studying knee osteoarthritis. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Anterior Cruciate Ligament Injuries
How many people
110 participants
Where
1 siteChina
Study dates
2 Feb 2018to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Inclusion criteria: Age: 18-35 years old. Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital. With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures). All participants have no known disorders or diseases other than ACL rupture. Exclusion criteria: Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.

Who may be able to join

  • 18-35 years old
  • Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.
  • With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures).
  • All participants have no known disorders or diseases other than ACL rupture.

Who cannot join

  • Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking University Third Hospital

    Beijing, 100191

Other trials in China

About this study

Official title: Ultrasound Evaluation of Hamstring Tendon Regeneration After Anterior Cruciate Ligament Reconstruction and Its Influence on Gait Touch Information

High incidence rate of knee osteoarthritis and gait analysis are important for early assessment of biomechanics. ACL injury is an ideal clinical model for studying knee osteoarthritis.

To clarify the mechanism between the biomechanical status of knee joint and the change of gait touch information, and to provide scientific basis for quantifying and evaluating the biomechanical status of knee joint in dynamic load-bearing state.

Read the detailed description

Objective: to analyze the shape and function of the regenerated hamstring tendon within 2 years after the removal of the hamstring tendon in ACL reconstruction, reveal the change rule of the characteristics of hamstring tendon regeneration and its biomechanical changes, and guide the selection of operation and postoperative rehabilitation.

Methods: 55 healthy people and 55 male patients with ACL reconstruction were recruited. All completed the basic rehabilitation training under the guidance of the postoperative rehabilitation program. Using infrared motion capture system, three-dimensional force measuring platform, isokinetic muscle force testing system and ultrasound, the anterior cruciate ligament reconstruction patients were tested before operation, 2 weeks, 3 months, 6 months, 12 months after operation and 24 months after operation.

Outcome evaluation indicators and statistical methods: evaluation indicators: (1) three dimensional motion capture and analysis results: 1) peak ground reaction force; 2) three-dimensional angle and torque of hip, knee and ankle joints in different stages; (2) isokinetic muscle strength results: bilateral knee extension torque and knee flexion torque at different angles and angular velocities. (3)Ultrasound evaluation: the thickness, cross-sectional area and shear wave velocity of the semitendinosus were measured.

Statistical methods: ① repeated measurement analysis of variance (ANOVA) was used to test the effects of different time after operation on the three-dimensional gait characteristics, muscle strength and tendon regeneration characteristics. ② Independent sample t-test was used to test the three-dimensional characteristics, muscle strength and tendon condition of patients at different time points after operation. ③ The difference of three-dimensional gait characteristics, muscle strength and tendon between the healthy side and the affected side at different time points after operation were examined by paired sample t-test. ④ Bivariate correlation analysis was used to analyze whether the thickness, cross-sectional area, shear wave propagation velocity and postoperative time were related.

Being tested
no intervention
Keywords
anterior cruciate ligament, gait analysis, plantar pressure, Ultrasound evaluation
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no interventionOther

    This is an observation study, with no intervention

Study groups in NCT04961736
Study groupRoleWhat they receive
Anterior Cruciate Ligament injury and reconstruction groupAccording to the previous clinical diagnosis, volunteers who has never suffered the Anterior Cruciate Ligament injury.
Receives: Other: no intervention
normal control groupAccording to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.
Receives: Other: no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. peak ground reaction force

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: On the day of enrollment.

  2. peak ground reaction force

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 3 months after Anterior Cruciate Ligament reconstruction.

  3. peak ground reaction force

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 6 months after Anterior Cruciate Ligament reconstruction.

  4. peak ground reaction force

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 12 months after Anterior Cruciate Ligament reconstruction.

  5. peak ground reaction force

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 24 months after Anterior Cruciate Ligament reconstruction.

  6. angle of hip in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 24 months after Anterior Cruciate Ligament reconstruction.

  7. angle of hip in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: On the day of enrollment.

  8. angle of hip in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 3 months after Anterior Cruciate Ligament reconstruction.

  9. angle of hip in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 6 months after Anterior Cruciate Ligament reconstruction.

  10. angle of hip in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 12 months after Anterior Cruciate Ligament reconstruction.

  11. bilateral knee extension torque

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: On the day of enrollment.

  12. bilateral knee extension torque

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 3 months after Anterior Cruciate Ligament reconstruction.

  13. bilateral knee extension torque

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 6 months after Anterior Cruciate Ligament reconstruction.

  14. bilateral knee extension torque

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 12 months after Anterior Cruciate Ligament reconstruction.

  15. bilateral knee extension torque

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 24 months after Anterior Cruciate Ligament reconstruction.

  16. knee flexion torque at different angles

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: On the day of enrollment.

  17. knee flexion torque at different angles

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 3 months after Anterior Cruciate Ligament reconstruction.

  18. knee flexion torque at different angles

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 6 months after Anterior Cruciate Ligament reconstruction.

  19. knee flexion torque at different angles

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 12 months after Anterior Cruciate Ligament reconstruction.

  20. knee flexion torque at different angles

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 24 months after Anterior Cruciate Ligament reconstruction.

  21. angular velocities

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: On the day of enrollment.

  22. angular velocities

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 3 months after Anterior Cruciate Ligament reconstruction.

  23. angular velocities

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 6 months after Anterior Cruciate Ligament reconstruction.

  24. angular velocities

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 12 months after Anterior Cruciate Ligament reconstruction.

  25. angular velocities

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 24 months after Anterior Cruciate Ligament reconstruction.

  26. the thickness of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: On the day of enrollment.

  27. the cross-sectional area of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: On the day of enrollment.

  28. the thickness of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 2 weeks after Anterior Cruciate Ligament reconstruction.

  29. the cross-sectional area of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 2 weeks after Anterior Cruciate Ligament reconstruction.

  30. the thickness of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 3 months after Anterior Cruciate Ligament reconstruction.

  31. the cross-sectional area of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 3 months after Anterior Cruciate Ligament reconstruction.

  32. the thickness of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 6 months after Anterior Cruciate Ligament reconstruction.

  33. the cross-sectional area of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 6 months after Anterior Cruciate Ligament reconstruction.

  34. the thickness of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 12 months after Anterior Cruciate Ligament reconstruction.

  35. the cross-sectional area of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 12 months after Anterior Cruciate Ligament reconstruction.

  36. the thickness of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 24 months after Anterior Cruciate Ligament reconstruction.

  37. the cross-sectional area of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 24 months after Anterior Cruciate Ligament reconstruction.

  38. shear wave velocity of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: On the day of enrollment.

  39. shear wave velocity of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 3 months after Anterior Cruciate Ligament reconstruction.

  40. shear wave velocity of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 6 months after Anterior Cruciate Ligament reconstruction.

  41. shear wave velocity of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 12 months after Anterior Cruciate Ligament reconstruction.

  42. shear wave velocity of the semitendinosus

    Ultrasound evaluation was made by Ultrasonic detector.

    Measured: At 24 months after Anterior Cruciate Ligament reconstruction.

  43. torque of hip, knee and ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 24 months after Anterior Cruciate Ligament reconstruction.

  44. torque of hip, knee and ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: On the day of enrollment.

  45. torque of hip, knee and ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 3 months after Anterior Cruciate Ligament reconstruction.

  46. torque of hip, knee and ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 6 months after Anterior Cruciate Ligament reconstruction.

  47. torque of hip, knee and ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 12 months after Anterior Cruciate Ligament reconstruction.

  48. angle of knee joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: On the day of enrollment.

  49. angle of knee joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 3 months after Anterior Cruciate Ligament reconstruction.

  50. angle of knee joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 6 months after Anterior Cruciate Ligament reconstruction.

  51. angle of knee joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 12 months after Anterior Cruciate Ligament reconstruction.

  52. angle of knee joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 24 months after Anterior Cruciate Ligament reconstruction.

  53. angle of ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: On the day of enrollment.

  54. angle of ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 3 months after Anterior Cruciate Ligament reconstruction.

  55. angle of ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 6 months after Anterior Cruciate Ligament reconstruction.

  56. angle of ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 12 months after Anterior Cruciate Ligament reconstruction.

  57. angle of ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 24 months after Anterior Cruciate Ligament reconstruction.

  58. torque of knee joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: On the day of enrollment.

  59. torque of knee joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 3 months after Anterior Cruciate Ligament reconstruction.

  60. torque of knee joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 6 months after Anterior Cruciate Ligament reconstruction.

  61. torque of knee joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 12 months after Anterior Cruciate Ligament reconstruction.

  62. torque of knee joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 24 months after Anterior Cruciate Ligament reconstruction.

  63. torque of ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: On the day of enrollment.

  64. torque of ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 3 months after Anterior Cruciate Ligament reconstruction.

  65. torque of ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 6 months after Anterior Cruciate Ligament reconstruction.

  66. torque of ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 12 months after Anterior Cruciate Ligament reconstruction.

  67. torque of ankle joints in different stages

    Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping.

    Measured: At 24 months after Anterior Cruciate Ligament reconstruction.

Secondary outcomes (1)
  1. The International Knee Documentation Committee (IKDC) score

    The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.

    Measured: On the day of enrollment, at 3 months, 6 months, 12 months after operation and 24 months after Anterior Cruciate Ligament reconstruction.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2021
  2. Study start2 Feb 2018
  3. Primary completion8 Jan 2020
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04961736
Sponsor's protocol ID
OR005
Status last verified
Jul 2020
First submitted
29 Jun 2020
Last updated
14 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

peak ground reaction force (time frame: On the day of enrollment.). The study lists 67 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.

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