Clinical trial NCT05924178: Effects of Preoperative Rehabilitation on Tendon Healing and Bone Mineral Density After ACLR
Official title: A Study on the Effect of Exercise Rehabilitation on Bone Mineral Density and Reconstruction Ligament Tendon Bone Healing After ACL Rupture
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Grade of tendon bone healing
timeFrame: At 6 monthes post operation.
measure: Grade of tendon bone healing
timeFrame: At 1 year post operation.
measure: balanced capacity
timeFrame: At preoperative.
measure: balanced capacity
timeFrame: At 6 monthes post operation.
measure: balanced capacity
timeFrame: At 1 year post operation.
measure: knee T1 rho value
timeFrame: At 6 months post operation.
measure: knee T1 rho value
timeFrame: At 1 year post operation.
measure: knee T2 value
timeFrame: At 6 months post operation.
measure: knee T2 value
timeFrame: At 1 year post operation.
measure: knee extension angles
timeFrame: At 6 months post operation.
measure: knee extension angles
timeFrame: At 1 year post operation.
measure: Graft maturity
timeFrame: At 6 monthes post operation.
measure: Graft maturity
timeFrame: At 1 year post operation.
measure: bone mineral density
timeFrame: At preoperative.
measure: bone mineral density
timeFrame: At 6 monthes post operation.
measure: bone mineral density
timeFrame: At 1 year post operation.
measure: isokinetic muscle strength
timeFrame: At preoperative.
measure: isokinetic muscle strength
timeFrame: At 6 monthes post operation.
measure: isokinetic muscle strength
timeFrame: At 1 year post operation.
Secondary outcomes:
Other outcomes:
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