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

Not Applicable

Not yet recruiting

• Conditions: Anterior Cruciate Ligament Rupture
• Interventions: Behavioral: routine treatment; Behavioral: exercise rehablitation

• Registration Number: NCT05924178
• Lead Sponsor: Peking University Third Hospital

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.

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 Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-05-28
• Study First Submitted QC: 2023-06-27
• Last Update Submitted: 2023-06-27
• Study First Posted: 2023-06-29
• Last Update Posted: 2023-06-29
• Study Start: 2023-07-10
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	routine treatment	Regular rehabilitation training was not performed before ACL reconstruction, got regular treatment. The ACL reconstruction was followed by a 0.5 year rehabilitation.
experimental group	exercise rehablitation	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.

Primary Outcome Measures

Name	Time	Method
knee T1 rho value	At 1 year post operation.	knee T1 rho value by functional MRI
knee T2 value	At 1 year post operation.	knee T2 rho value by functional MRI
balanced capacity	At 1 year post operation.	Y balance test
Grade of tendon bone healing	At 1 year post operation.	tendon bone healing by knee MRI
knee extension angles	At 1 year post operation.	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Graft maturity	At 1 year post operation.	tendon bone healing by knee MRI
bone mineral density	At 1 year post operation.	bone mineral density by knee DEX
isokinetic muscle strength	At 1 year post operation.	Knee isokinetic strength test