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

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05924178
• Other study ID #: M2022837
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2023
• Source: Peking University Third Hospital
• Contact: Shuang Ren
• Phone: 17610252992
• Email: xixishuang123[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

Behavioral:
• exercise rehablitation
Preoperative exercise rehabilitation in experimental group was performed.
• routine treatment
The control group receives conventional treatment preoperative.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade of tendon bone healing	tendon bone healing by knee MRI	At 6 monthes post operation.
Primary	Grade of tendon bone healing	tendon bone healing by knee MRI	At 1 year post operation.
Primary	balanced capacity	Y balance test	At preoperative.
Primary	balanced capacity	Y balance test	At 6 monthes post operation.
Primary	balanced capacity	Y balance test	At 1 year post operation.
Primary	knee T1 rho value	knee T1 rho value by functional MRI	At 6 months post operation.
Primary	knee T1 rho value	knee T1 rho value by functional MRI	At 1 year post operation.
Primary	knee T2 value	knee T2 rho value by functional MRI	At 6 months post operation.
Primary	knee T2 value	knee T2 rho value by functional MRI	At 1 year post operation.
Primary	knee extension angles	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 6 months post operation.
Primary	knee extension angles	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 1 year post operation.
Primary	Graft maturity	tendon bone healing by knee MRI	At 6 monthes post operation.
Primary	Graft maturity	tendon bone healing by knee MRI	At 1 year post operation.
Primary	bone mineral density	bone mineral density by knee DEX	At preoperative.
Primary	bone mineral density	bone mineral density by knee DEX	At 6 monthes post operation.
Primary	bone mineral density	bone mineral density by knee DEX	At 1 year post operation.
Primary	isokinetic muscle strength	Knee isokinetic strength test	At preoperative.
Primary	isokinetic muscle strength	Knee isokinetic strength test	At 6 monthes post operation.
Primary	isokinetic muscle strength	Knee isokinetic strength test	At 1 year post operation.