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

NCT ID: NCT05924178

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2026-06-01

Brief Summary

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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

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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.

Conditions

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Anterior Cruciate Ligament Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

exercise rehablitation

Intervention Type BEHAVIORAL

Preoperative exercise rehabilitation in experimental group was performed.

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.

Group Type ACTIVE_COMPARATOR

routine treatment

Intervention Type BEHAVIORAL

The control group receives conventional treatment preoperative.

Interventions

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exercise rehablitation

Preoperative exercise rehabilitation in experimental group was performed.

Intervention Type BEHAVIORAL

routine treatment

The control group receives conventional treatment preoperative.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Be older than 40 years, or less than 18 years old
2. Severe injury to other knee ligaments
3. History of knee trauma
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuang Ren

Role: CONTACT

17610252992

Facility Contacts

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ren shuang

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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M2022837

Identifier Type: -

Identifier Source: org_study_id

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