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NCT Number: NCT05924178

Effects of Preoperative Rehabilitation on Tendon Healing, Bone Mineral Density, and Cartilage After ACLR and Patellar Dislocation

To explore the effect of preoperative exercise rehabilitation on bone mineral density, tendon bone healing, change of cartilage, and gait feature in patients with anterior cruciate ligament rupture.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, China

Location status: Recruiting

Location contact

ren shuang

CONTACT

[email protected]

About this study

Anterior Cruciate Ligament (ACL) injury is one of the most common sports injuries. It is a serious knee injury. The fracture of ACL can cause functional instability of knee joint, damage of meniscus and articular cartilage, and even induce knee osteoarthritis and other diseases. It has great influence on knee joint and even lower limb function of patients. Arthroscopic ACL reconstruction has become the first choice in clinical treatment of ACL fracture.

ACL fracture can cause local knee joint osteoporosis, and reconstruction surgery can also affect tendon bone healing, bone canal enlargement, rehabilitation period, gait, articular cartilage degradation, etc.

This study intends to conduct preoperative rehabilitation intervention for young people with anterior fork rupture, and explore the effects of exercise rehabilitation on knee bone mineral density, muscle strength, proprioceptive ability and other aspects after ACL rupture, as well as the effects of knee bone mineral density, tendon bone healing, bone tunnel aperture, motor function, gait characteristics and cartilage degradation after reconstruction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18~40 years old, diagnosed ACL rupture or Patellar Dislocation by MRI;
  • The first unilateral ligamenta reconstruction at our hospital;

Exclusion criteria

  • Be older than 40 years, or less than 18 years old
  • Severe injury to other knee ligaments
  • History of knee trauma

Treatment and study plan

exercise rehablitation

Behavioral

Preoperative exercise rehabilitation in experimental group was performed.

Routine Treatment

Behavioral

The control group receives conventional treatment preoperative.

Primary outcomes

  1. Grade of tendon bone healing

    Time frame: At 6 monthes post operation.

    tendon bone healing by knee MRI

  2. Grade of tendon bone healing

    Time frame: At 1 year post operation.

    tendon bone healing by knee MRI

  3. balanced capacity

    Time frame: At preoperative.

    Y balance test

  4. balanced capacity

    Time frame: At 6 monthes post operation.

    Y balance test

  5. balanced capacity

    Time frame: At 1 year post operation.

    Y balance test

  6. knee T1 rho value

    Time frame: At 6 months post operation.

    knee T1 rho value by functional MRI

  7. knee T1 rho value

    Time frame: At 1 year post operation.

    knee T1 rho value by functional MRI

  8. knee T2 value

    Time frame: At 6 months post operation.

    knee T2 rho value by functional MRI

  9. knee T2 value

    Time frame: At 1 year post operation.

    knee T2 rho value by functional MRI

  10. knee extension angles

    Time frame: At 6 months post operation.

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

  11. knee extension angles

    Time frame: At 1 year post operation.

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

  12. Graft maturity

    Time frame: At 6 monthes post operation.

    tendon bone healing by knee MRI

  13. Graft maturity

    Time frame: At 1 year post operation.

    tendon bone healing by knee MRI

  14. bone mineral density

    Time frame: At preoperative.

    bone mineral density by knee DEX

  15. bone mineral density

    Time frame: At 6 monthes post operation.

    bone mineral density by knee DEX

  16. bone mineral density

    Time frame: At 1 year post operation.

    bone mineral density by knee DEX

  17. isokinetic muscle strength

    Time frame: At preoperative.

    Knee isokinetic strength test

  18. isokinetic muscle strength

    Time frame: At 6 monthes post operation.

    Knee isokinetic strength test

  19. isokinetic muscle strength

    Time frame: At 1 year post operation.

    Knee isokinetic strength test

  20. Grade of tendon bone healing

    Time frame: At 2 years post operation.

    tendon bone healing by knee MRI

  21. balanced capacity

    Time frame: At 2 years post operation.

    Y balance test

  22. Graft maturity

    Time frame: At 2 years post operation.

    tendon bone healing by knee MRI

  23. isokinetic muscle strength

    Time frame: At 2 years post operation.

    Knee isokinetic strength test

Secondary outcomes

  1. The HU value of CT

    Time frame: at pre-operation

    CT test

  2. Thigh Circumference

    Time frame: At 2 years post operation.

    the circumference of 15 cm above the superior aspect of the patella

  3. Thigh Circumference

    Time frame: At 1 year post operation.

    the circumference of 15 cm above the superior aspect of the patella

  4. Thigh Circumference

    Time frame: At 6 monthes post operation.

    the circumference of 15 cm above the superior aspect of the patella

  5. Thigh Circumference

    Time frame: At pre-operation.

    the circumference of 15 cm above the superior aspect of the patella

  6. Single-Leg Hop

    Time frame: At 1 year post operation.

    a maximal-distance hop

  7. Single-Leg Hop

    Time frame: At 2 years post operation.

    a maximal-distance hop

Study contacts

Contact information is provided by the study sponsor or research team.

Shuang Ren

CONTACT

[email protected]

17610252992

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

A Study on the Effect of Exercise Rehabilitation on Bone Mineral Density, Reconstruction Ligament Tendon Bone Healing and Cartilage After ACL Rupture and Patellar Dislocation

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2023
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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