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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Behavioral: exercise rehablitation; Behavioral: routine treatment

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuang Ren; Phone Number: 17610252992; Email: xixishuang123@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: ren shuang; Phone Number: xixishuang123@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knee T1 rho value	knee T1 rho value by functional MRI	At 6 months post operation.
knee extension angles	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 6 months post operation.
Grade of tendon bone healing	tendon bone healing by knee MRI	At 6 monthes post operation.
Grade of tendon bone healing	tendon bone healing by knee MRI	At 1 year post operation.
balanced capacity	Y balance test	At preoperative.
balanced capacity	Y balance test	At 6 monthes post operation.
balanced capacity	Y balance test	At 1 year post operation.
knee T1 rho value	knee T1 rho value by functional MRI	At 1 year post operation.
knee T2 value	knee T2 rho value by functional MRI	At 6 months post operation.
knee T2 value	knee T2 rho value by functional MRI	At 1 year post operation.
knee extension angles	Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping	At 1 year post operation.
Graft maturity	tendon bone healing by knee MRI	At 6 monthes post operation.
Graft maturity	tendon bone healing by knee MRI	At 1 year post operation.
bone mineral density	bone mineral density by knee DEX	At preoperative.
bone mineral density	bone mineral density by knee DEX	At 6 monthes post operation.
bone mineral density	bone mineral density by knee DEX	At 1 year post operation.
isokinetic muscle strength	Knee isokinetic strength test	At preoperative.
isokinetic muscle strength	Knee isokinetic strength test	At 6 monthes post operation.
isokinetic muscle strength	Knee isokinetic strength test	At 1 year post operation.
Grade of tendon bone healing	tendon bone healing by knee MRI	At 2 years post operation.
balanced capacity	Y balance test	At 2 years post operation.
Graft maturity	tendon bone healing by knee MRI	At 2 years post operation.
isokinetic muscle strength	Knee isokinetic strength test	At 2 years post operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The HU value of CT	CT test	at pre-operation
Thigh Circumference	the circumference of 15 cm above the superior aspect of the patella	At 2 years post operation.
Thigh Circumference	the circumference of 15 cm above the superior aspect of the patella	At 1 year post operation.
Thigh Circumference	the circumference of 15 cm above the superior aspect of the patella	At 6 monthes post operation.
Thigh Circumference	the circumference of 15 cm above the superior aspect of the patella	At pre-operation.
Single-Leg Hop	a maximal-distance hop	At 1 year post operation.
Single-Leg Hop	a maximal-distance hop	At 2 years post operation.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 28, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: M2022837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Can contact the author to communicate and obtain the corresponding data.
• IPD Sharing Time Frame: 1/6/2025-1/9/2025
• IPD Sharing Access Criteria: Relevant data on bone mineral density and physical function can be accessed through the ClinicalTrials.gov website.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No