Clinical trial NCT03984474: The Clinical Outcome of Anterior Cruciate Ligament Reconstruction
Official title: Institute of Sports Medicine of Peking University Third Hospital, Beijing, China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Anterior Cruciate Ligament Reconstruction
Patient-reported outcome
Meniscus
Cartilage
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Inner Mongolia People's Hospital
name: Peking Union Medical College Hospital
First posted: 2019-06-13
Enrollment: 100
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the anterior cruciate ligament reconstruction in the Peking University Third Hospital during 1999-2017.

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.

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.

Eligibility criteria: Inclusion Criteria:

diagnosis of isolated anterior cruciate ligament rupture

Exclusion Criteria:

combined other ligament damage combined intraarticular injuries

Primary outcomes:
measure: International Knee Documentation Committee(IKDC) score
timeFrame: Preoperative
measure: International Knee Documentation Committee(IKDC) score
timeFrame: 2 years after surgery
measure: International Knee Documentation Committee(IKDC) score
timeFrame: 5-8 years after surgery
measure: International Knee Documentation Committee(IKDC) score
timeFrame: 10-15 years after surgery
measure: International Knee Documentation Committee(IKDC) score
timeFrame: an average of 20 year
measure: KT-2000 test
timeFrame: 2 years after surgery
measure: KT-2000 test
timeFrame: 5-8 years after surgery
measure: KT-2000 test
timeFrame: 10-15 years after surgery
measure: KT-2000 test
timeFrame: an average of 20 year
measure: Magnatic Resonance Imaging evaluation
timeFrame: Preoperative
measure: Magnatic Resonance Imaging evaluation
timeFrame: 2 years after surgery
measure: Magnatic Resonance Imaging evaluation
timeFrame: 5-8 years after surgery
measure: Magnatic Resonance Imaging evaluation
timeFrame: 10-15 years after surgery
measure: Magnatic Resonance Imaging evaluation
timeFrame: an average of 20 year
Secondary outcomes:
measure: Skeletal force line and various angles by X-ray evaluation
timeFrame: Preoperative
measure: Skeletal force line and various angles by X-ray evaluation
timeFrame: 2 years after surgery
measure: Skeletal force line and various angles by X-ray evaluation
timeFrame: 5-8 years after surgery
measure: Skeletal force line and various angles by X-ray evaluation
timeFrame: 10-15 years after surgery
measure: Skeletal force line and various angles by X-ray evaluation
timeFrame: an average of 20 year
Other outcomes:
measure: Biomechanical analysis of human gait
timeFrame: 2 years after surgery
measure: Biomechanical analysis of human gait
timeFrame: 5-8 years after surgery
measure: Biomechanical analysis of human gait
timeFrame: 10-15 years after surgery
measure: Biomechanical analysis of human gait
timeFrame: an average of 20 year
measure: Rotational torque of knee by Biodex system isokinetic testing
timeFrame: 2 years after surgery
measure: Rotational torque of knee by Biodex system isokinetic testing
timeFrame: 5-8 years after surgery
measure: Rotational torque of knee by Biodex system isokinetic testing
timeFrame: 10-15 years after surgery
measure: Rotational torque of knee by Biodex system isokinetic testing
timeFrame: an average of 20 year
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Jia-Kuo Yu, Doctor
role: STUDY_CHAIR
References:
citation: 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.