Effects of Preoperative Rehabilitation on Tendon Healing and Bone Mineral Density After ACLR

Sponsor
Peking University Third Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05924178
Collaborator
(none)
60
2
31.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: exercise rehablitation
  • Behavioral: routine treatment
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Study on the Effect of Exercise Rehabilitation on Bone Mineral Density and Reconstruction Ligament Tendon Bone Healing After ACL Rupture
Anticipated Study Start Date :
Jul 10, 2023
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

Before ACL reconstruction,40 minutes of rehabilitation training was performed 3 times a week for 6 weeks, and gotted regular treatment. The ACL reconstruction was followed by a 0.5 year rehabilitation.

Behavioral: exercise rehablitation
Preoperative exercise rehabilitation in experimental group was performed.

Active Comparator: control group

Regular rehabilitation training was not performed before ACL reconstruction, got regular treatment. The ACL reconstruction was followed by a 0.5 year rehabilitation.

Behavioral: routine treatment
The control group receives conventional treatment preoperative.

Outcome Measures

Primary Outcome Measures

  1. Grade of tendon bone healing [At 6 monthes post operation.]

    tendon bone healing by knee MRI

  2. Grade of tendon bone healing [At 1 year post operation.]

    tendon bone healing by knee MRI

  3. balanced capacity [At preoperative.]

    Y balance test

  4. balanced capacity [At 6 monthes post operation.]

    Y balance test

  5. balanced capacity [At 1 year post operation.]

    Y balance test

  6. knee T1 rho value [At 6 months post operation.]

    knee T1 rho value by functional MRI

  7. knee T1 rho value [At 1 year post operation.]

    knee T1 rho value by functional MRI

  8. knee T2 value [At 6 months post operation.]

    knee T2 rho value by functional MRI

  9. knee T2 value [At 1 year post operation.]

    knee T2 rho value by functional MRI

  10. knee extension angles [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 [At 1 year post operation.]

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

  12. Graft maturity [At 6 monthes post operation.]

    tendon bone healing by knee MRI

  13. Graft maturity [At 1 year post operation.]

    tendon bone healing by knee MRI

  14. bone mineral density [At preoperative.]

    bone mineral density by knee DEX

  15. bone mineral density [At 6 monthes post operation.]

    bone mineral density by knee DEX

  16. bone mineral density [At 1 year post operation.]

    bone mineral density by knee DEX

  17. isokinetic muscle strength [At preoperative.]

    Knee isokinetic strength test

  18. isokinetic muscle strength [At 6 monthes post operation.]

    Knee isokinetic strength test

  19. isokinetic muscle strength [At 1 year post operation.]

    Knee isokinetic strength test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age 18~40 years old, diagnosed ACL rupture by MRI;

  2. The first unilateral ACL rupture requires reconstruction at our hospital;

  3. Greater than 6 weeks from trauma and within 6 months.

Exclusion Criteria:
  1. Be older than 40 years, or less than 18 years old

  2. Within 8 weeks of the onset of the trauma, or more than 1 year

  3. Severe injury to other knee ligaments

  4. History of knee trauma

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT05924178
Other Study ID Numbers:
  • M2022837
First Posted:
Jun 29, 2023
Last Update Posted:
Jun 29, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2023