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

NCT05924178 | Recruiting

• 1 other identifier: M2022837
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (23)

• 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 6 months 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 6 months 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 Outcomes (7)

• The HU value of CT

  at pre-operation

• Thigh Circumference

  At 2 years post operation.

• Thigh Circumference

  At 1 year post operation.

• Thigh Circumference

  At 6 monthes post operation.

• Thigh Circumference

  At pre-operation.

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

exercise rehablitation BEHAVIORAL

Preoperative exercise rehabilitation in experimental group was performed.

experimental group

routine treatment BEHAVIORAL

The control group receives conventional treatment preoperative.

control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Be older than 40 years, or less than 18 years old
• Severe injury to other knee ligaments
• History of knee trauma

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Shuang Ren

CONTACT

17610252992; xixishuang123@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 29, 2023
• Study Start: July 10, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1/6/2025-1/9/2025
• Access Criteria: Relevant data on bone mineral density and physical function can be accessed through the ClinicalTrials.gov website.

Locations

CN (1)