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The Clinical Outcome of Anterior Cruciate Ligament Reconstruction (RCACLR)

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ClinicalTrials.gov Identifier: NCT03984474
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborators:
Inner Mongolia People's Hospital
Peking Union Medical College Hospital
Information provided by (Responsible Party):
Jia-kuo yu, Peking University Third Hospital

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.


Condition or disease
Anterior Cruciate Ligament Rupture

Detailed Description:
Age 13-65 included. Only include isolated anterior cruciate ligament(ACL) rupture. Excluded revision surgery. Excluded bilateral ACL rupture. Excluded the contralateral ACL tear after surgery. 40 patients at least in each group.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Institute of Sports Medicine of Peking University Third Hospital, Beijing, China
Actual Study Start Date : January 14, 2003
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. International Knee Documentation Committee(IKDC) score [ Time Frame: Preoperative ]
    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. International Knee Documentation Committee(IKDC) score [ Time Frame: 2 years after surgery ]
    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.

  3. International Knee Documentation Committee(IKDC) score [ Time Frame: 5-8 years after surgery ]
    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.

  4. International Knee Documentation Committee(IKDC) score [ Time Frame: 10-15 years after surgery ]
    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. International Knee Documentation Committee(IKDC) score [ Time Frame: an average of 20 year ]
    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.

  6. KT-2000 test [ Time Frame: 2 years after surgery ]
    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.

  7. KT-2000 test [ Time Frame: 5-8 years after surgery ]
    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.

  8. KT-2000 test [ Time Frame: 10-15 years after surgery ]
    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.

  9. KT-2000 test [ Time Frame: an average of 20 year ]
    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. Magnatic Resonance Imaging evaluation [ Time Frame: Preoperative ]
    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).

  11. Magnatic Resonance Imaging evaluation [ Time Frame: 2 years after surgery ]
    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).

  12. Magnatic Resonance Imaging evaluation [ Time Frame: 5-8 years after surgery ]
    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).

  13. Magnatic Resonance Imaging evaluation [ Time Frame: 10-15 years after surgery ]
    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).

  14. Magnatic Resonance Imaging evaluation [ Time Frame: an average of 20 year ]
    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).


Secondary Outcome Measures :
  1. Skeletal force line and various angles by X-ray evaluation [ Time Frame: Preoperative ]
    X-ray was used to evaluate the skeletal force line and various angles of patients. Use Qvadriceps Angle to evaluate quadriceps force line and patellar ligament force line. The normal Angle is 18-22° for the adult standing position.Above or below this range is considered abnormal.

  2. Skeletal force line and various angles by X-ray evaluation [ Time Frame: 2 years after surgery ]
    X-ray was used to evaluate the skeletal force line and various angles of patients. Use Qvadriceps Angle to evaluate quadriceps force line and patellar ligament force line. The normal Angle is 18-22° for the adult standing position.Above or below this range is considered abnormal.

  3. Skeletal force line and various angles by X-ray evaluation [ Time Frame: 5-8 years after surgery ]
    X-ray was used to evaluate the skeletal force line and various angles of patients. Use Qvadriceps Angle to evaluate quadriceps force line and patellar ligament force line. The normal Angle is 18-22° for the adult standing position.Above or below this range is considered abnormal.

  4. Skeletal force line and various angles by X-ray evaluation [ Time Frame: 10-15 years after surgery ]
    X-ray was used to evaluate the skeletal force line and various angles of patients. Use Qvadriceps Angle to evaluate quadriceps force line and patellar ligament force line. The normal Angle is 18-22° for the adult standing position.Above or below this range is considered abnormal.

  5. Skeletal force line and various angles by X-ray evaluation [ Time Frame: an average of 20 year ]
    X-ray was used to evaluate the skeletal force line and various angles of patients. Use Qvadriceps Angle to evaluate quadriceps force line and patellar ligament force line. The normal Angle is 18-22° for the adult standing position.Above or below this range is considered abnormal.


Other Outcome Measures:
  1. Biomechanical analysis of human gait [ Time Frame: 2 years after surgery ]
    Biomechanical analysis of human gait was performed in all patients under load and no load conditions. Step length, cadence, speed and Angle of patients were evaluated, and then the assessment reports were summarized into "similar" or "abnormal" ones with normal people.

  2. Biomechanical analysis of human gait [ Time Frame: 5-8 years after surgery ]
    Biomechanical analysis of human gait was performed in all patients under load and no load conditions. Step length, cadence, speed and Angle of patients were evaluated, and then the assessment reports were summarized into "similar" or "abnormal" ones with normal people.

  3. Biomechanical analysis of human gait [ Time Frame: 10-15 years after surgery ]
    Biomechanical analysis of human gait was performed in all patients under load and no load conditions. Step length, cadence, speed and Angle of patients were evaluated, and then the assessment reports were summarized into "similar" or "abnormal" ones with normal people.

  4. Biomechanical analysis of human gait [ Time Frame: an average of 20 year ]
    Biomechanical analysis of human gait was performed in all patients under load and no load conditions. Step length, cadence, speed and Angle of patients were evaluated, and then the assessment reports were summarized into "similar" or "abnormal" ones with normal people.

  5. Rotational torque of knee by Biodex system isokinetic testing [ Time Frame: 2 years after surgery ]
    Use Biodex system(BIODEXMEDICALSYSTEMS,INC) to assess the increase or decrease in the amount of rotational torque applied to the patient's limb velocity as it accelerates and decelerates. The equal-velocity quadriceps moment of the operating leg up to 85% of the uninjured side is considered normal.

  6. Rotational torque of knee by Biodex system isokinetic testing [ Time Frame: 5-8 years after surgery ]
    Use Biodex system(BIODEXMEDICALSYSTEMS,INC) to assess the increase or decrease in the amount of rotational torque applied to the patient's limb velocity as it accelerates and decelerates. The equal-velocity quadriceps moment of the operating leg up to 85% of the uninjured side is considered normal.

  7. Rotational torque of knee by Biodex system isokinetic testing [ Time Frame: 10-15 years after surgery ]
    Use Biodex system(BIODEXMEDICALSYSTEMS,INC) to assess the increase or decrease in the amount of rotational torque applied to the patient's limb velocity as it accelerates and decelerates. The equal-velocity quadriceps moment of the operating leg up to 85% of the uninjured side is considered normal.

  8. Rotational torque of knee by Biodex system isokinetic testing [ Time Frame: an average of 20 year ]
    Use Biodex system(BIODEXMEDICALSYSTEMS,INC) to assess the increase or decrease in the amount of rotational torque applied to the patient's limb velocity as it accelerates and decelerates. The equal-velocity quadriceps moment of the operating leg up to 85% of the uninjured side is considered normal.



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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with the anterior cruciate ligament reconstruction in the Peking University Third Hospital during 1999-2017.
Criteria

Inclusion Criteria:

diagnosis of isolated anterior cruciate ligament rupture

Exclusion Criteria:

combined other ligament damage combined intraarticular injuries


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984474


Contacts
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Contact: Jia-Kuo Yu, Doctor 861082267392 yujiakuo@126.com

Locations
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China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Jia-Kuo Yu, Doctor    86-10-82267392    yujiakuo@126.com   
Contact: Zi-Mu Mao, Doctor    8613716437053    mzm@pku.edu.cn   
Principal Investigator: Jia-Kuo Yu, Doctor         
Sub-Investigator: Zi-Mu Mao, Doctor         
Sponsors and Collaborators
Peking University Third Hospital
Inner Mongolia People's Hospital
Peking Union Medical College Hospital
Investigators
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Study Chair: Jia-Kuo Yu, Doctor Peking University Third Hospital

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Responsible Party: Jia-kuo yu, Deputy director of Institute of Sports Medicine of Peking University third hospital, Clinical Professor, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03984474     History of Changes
Other Study ID Numbers: ACLR-YJK
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jia-kuo yu, Peking University Third Hospital:
Anterior Cruciate Ligament Reconstruction
Patient-reported outcome
Meniscus
Cartilage

Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries