The Clinical Outcome of Anterior Cruciate Ligament Reconstruction

NCT03984474 | Unknown

• 1 other identifier: ACLR-YJK
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective cohort study. The investigators evaluated the early, middle and long term effects of different surgical methods of anterior cruciate ligament reconstruction on knee function. In the evaluation, the investigators focused on the differences between different age groups, different genders and different basic motor states, the differences between early reconstruction and non-early reconstruction, and the differences in clinical outcomes of different surgical methods.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Anterior Cruciate Ligament Reconstruction; Patient-reported outcome; Meniscus; Cartilage

Outcome Measures

Primary Outcomes (14)

• International Knee Documentation Committee(IKDC) score

  The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.

  Preoperative

• International Knee Documentation Committee(IKDC) score

  The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.

  2 years after surgery

• International Knee Documentation Committee(IKDC) score

  The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.

  5-8 years after surgery

• International Knee Documentation Committee(IKDC) score

  The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.

  10-15 years after surgery

• International Knee Documentation Committee(IKDC) score

  The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.

  an average of 20 year

• KT-2000 test

  It is a kind of joint measuring instrument used to determine the anteroposterior stability of knee joint. The contrast between the uninjured side and the surgical measurement showed that the difference of ≤3mm was considered excellent.

  2 years after surgery

• KT-2000 test

  It is a kind of joint measuring instrument used to determine the anteroposterior stability of knee joint. The contrast between the uninjured side and the surgical measurement showed that the difference of ≤3mm was considered excellent.

  5-8 years after surgery

• KT-2000 test

  It is a kind of joint measuring instrument used to determine the anteroposterior stability of knee joint. The contrast between the uninjured side and the surgical measurement showed that the difference of ≤3mm was considered excellent.

  10-15 years after surgery

• KT-2000 test

  It is a kind of joint measuring instrument used to determine the anteroposterior stability of knee joint. The contrast between the uninjured side and the surgical measurement showed that the difference of ≤3mm was considered excellent.

  an average of 20 year

• Magnatic Resonance Imaging evaluation

  All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).

  Preoperative

• Magnatic Resonance Imaging evaluation

  All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).

  2 years after surgery

• Magnatic Resonance Imaging evaluation

  All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).

  5-8 years after surgery

• Magnatic Resonance Imaging evaluation

  All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).

  10-15 years after surgery

• Magnatic Resonance Imaging evaluation

  All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).

  an average of 20 year

Secondary Outcomes (5)

• Skeletal force line and various angles by X-ray evaluation

  Preoperative

• Skeletal force line and various angles by X-ray evaluation

  2 years after surgery

• Skeletal force line and various angles by X-ray evaluation

  5-8 years after surgery

• Skeletal force line and various angles by X-ray evaluation

  10-15 years after surgery

• Skeletal force line and various angles by X-ray evaluation

  an average of 20 year

Other Outcomes (8)

• Biomechanical analysis of human gait

  2 years after surgery

• Biomechanical analysis of human gait

  5-8 years after surgery

• Biomechanical analysis of human gait

  10-15 years after surgery

Study Arms (2)

Single bundle group

Age 13-65 when enrolled. Only include isolated ACL rupture. Excluded revision surgery. Excluded bilateral ACL rupture. Excluded the contralateral ACL tear after surgery.

Double bundle group

Age 13-65 when enrolled. Only include isolated ACL rupture. Excluded revision surgery. Excluded bilateral ACL rupture. Excluded the contralateral ACL tear after surgery.

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with the anterior cruciate ligament reconstruction in the Peking University Third Hospital during 1999-2017.

You may qualify if:

• diagnosis of isolated anterior cruciate ligament rupture

You may not qualify if:

• combined other ligament damage combined intraarticular injuries

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Inner Mongolia People's Hospital: collaborator
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (1)

• Mao Z, Wang J, Wang Y, Jiang D, Wang X, Wang H, Lin L, Liu Y, Zeng L, Yu J. Double-bundle anterior cruciate ligament reconstruction technique has advantages in chondroprotection and knee laxity control compared with single-bundle technique : A long-term follow-up with a minimum of 12 years. Knee Surg Sports Traumatol Arthrosc. 2021 Sep;29(9):3105-3114. doi: 10.1007/s00167-020-06350-5. Epub 2020 Nov 20.

  PMID: 33216188 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Jia-Kuo Yu, Doctor

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Jia-Kuo Yu, Doctor

CONTACT

861082267392; yujiakuo@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of Institute of Sports Medicine of Peking University third hospital, Clinical Professor

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: June 13, 2019
• Study Start: January 14, 2003
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2021
• Last Updated: June 13, 2019

Record last verified: 2019-06

Locations

CN (1)