The Clinical Outcome of Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Rupture Clinical Trial

— RCACLR  

Official title:

Institute of Sports Medicine of Peking University Third Hospital, Beijing, China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03984474
• Other study ID #: ACLR-YJK
• Status: Recruiting
• Start date: January 14, 2003
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2019
• Source: Peking University Third Hospital
• Contact: Jia-Kuo Yu, Doctor
• Phone: 861082267392
• Email: yujiakuo[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 65 Years

Eligibility

Inclusion Criteria:

diagnosis of isolated anterior cruciate ligament rupture

Exclusion Criteria:

combined other ligament damage combined intraarticular injuries

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Rupture

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University Third Hospital	Inner Mongolia People's Hospital, Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomechanical analysis of human gait	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 years after surgery
Other	Biomechanical analysis of human gait	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.	5-8 years after surgery
Other	Biomechanical analysis of human gait	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.	10-15 years after surgery
Other	Biomechanical analysis of human gait	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.	an average of 20 year
Other	Rotational torque of knee by Biodex system isokinetic testing	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.	2 years after surgery
Other	Rotational torque of knee by Biodex system isokinetic testing	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.	5-8 years after surgery
Other	Rotational torque of knee by Biodex system isokinetic testing	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.	10-15 years after surgery
Other	Rotational torque of knee by Biodex system isokinetic testing	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.	an average of 20 year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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 ?: normal (12), grade ?: nearly normal (8-11), grade ?: abnormal (4-7), grade ?: severely abnormal (1-3).	Preoperative
Primary	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 ?: normal (12), grade ?: nearly normal (8-11), grade ?: abnormal (4-7), grade ?: severely abnormal (1-3).	2 years after surgery
Primary	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 ?: normal (12), grade ?: nearly normal (8-11), grade ?: abnormal (4-7), grade ?: severely abnormal (1-3).	5-8 years after surgery
Primary	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 ?: normal (12), grade ?: nearly normal (8-11), grade ?: abnormal (4-7), grade ?: severely abnormal (1-3).	10-15 years after surgery
Primary	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 ?: normal (12), grade ?: nearly normal (8-11), grade ?: abnormal (4-7), grade ?: severely abnormal (1-3).	an average of 20 year
Secondary	Skeletal force line and various angles by X-ray evaluation	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.	Preoperative
Secondary	Skeletal force line and various angles by X-ray evaluation	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 years after surgery
Secondary	Skeletal force line and various angles by X-ray evaluation	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.	5-8 years after surgery
Secondary	Skeletal force line and various angles by X-ray evaluation	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.	10-15 years after surgery
Secondary	Skeletal force line and various angles by X-ray evaluation	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.	an average of 20 year