Clinical trial NCT05403905: A Cohort Study of Non-surgical Treatment and Exercise Rehabilitation in Patients With Anterior Cruciate Ligament Rupture
Official title: A Cohort Study of Non-surgical Treatment and Exercise Rehabilitation in Patients -Chinese Population-based Cohort
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Osteoarthritis, Knee
Keywords: Anterior cruciate ligament (ACL)
OA
non-surgical treatment
rehabilitation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients who were diagnosed with complete rupture of the ACL in the outpatient department of Peking University Third Hospital, the sports medicine doctor explained in detail (1) the way of conservative treatment, (2) the ruptured anterior cruciate ligament has the possibility of healing after fixation and (3) Willing to join the cohort study after enrollment. There were 60 subjects in the non-surgical treatment group and 60 in the surgical treatment group, for a total of 120 subjects.
Primary purpose: TREATMENT

Brief summary: This clinical trial compared the prognosis of surgical and non-surgical treatment in patients with complete anterior cruciate ligament rupture

Detailed description: Anterior cruciate ligament injury is a common neuromuscular injury to the knee joint. The incidence rate is gradually increasing. There are 400,000 ACL reconstruction operations in the United States every year. The population of my country is equivalent to 4.3 times that of the United States. The potential economic burden of cruciate ligament reconstruction surgery on the country cannot be ignored. Anterior cruciate ligament reconstruction is seen as an effective treatment for this disease, avoiding secondary meniscus damage and knee degeneration, but the failure rate is still as high as 20%. In addition, problems such as poor bending angle caused by postoperative adhesions that may occur after surgery, atrophy of the quadriceps muscle of the patient's affected leg, and overstrain of the healthy leg caused by psychological factors may affect the quality of life after surgery. Reasons that prevent return to sports. The use of conservative treatment instead of surgery after recent ACL injury has received high attention, and a large number of RCTs have compared the benefits of surgery and conservative treatment.

Some reviews pointed out that the clinical outcomes of surgical treatment and conservative treatment are not much different, and even questioned the prognosis after anterior cruciate ligament reconstruction. Individual differentiated treatment is necessary.

Eligibility criteria: Inclusion Criteria:

* 1) Age 8-45 years old 2) Complete rupture of unilateral anterior cruciate ligament (ACL) (with/without partial meniscus tear) 3) The history of ACL injury should not be more than 2 months before enrollment 4) Complete rupture of the ACL as determined by clinical examination and MRI 5) Activity level scale 5-9 (Tegner activity score) 6) Degeneration of knee joint \<KL II degree, intraoperative cartilage injury \< ICRS III degree.

  7) The reason for the rupture of the anterior cruciate ligament is sports trauma.

  8) Complete rupture of the ACL meets the MRI indications: (1) The signal changes, deforms, and thickens on imaging, and is completely broken but not separated; (2) There is no sagging and separation of the broken ends; (3) The synovial image is continuous.

  9) The physical examination of complete ACL rupture meets the following indications: (1) Lachman (-) or ADT (-) has one of them; (2) or both are slightly loose, and the slack is not more than 10mm; (3) vertical Leg position ADT (-) or slack \<5mm.

Exclusion Criteria:

* 1) Used in the previous 12 months 1. Intra-articular injection 2. Physical therapy 2) Those who broke again after surgery and underwent knee surgery in other hospitals 3) Previous knee surgery (except diagnostic arthroscopy) 4) Active infection of the knee joint within the past 12 months 5) Informed consent cannot be given 6) History of knee gout 7) Include one or more of the following knee-related injuries: 8) Unstable meniscus tears requiring repair or post-operative changes in rehabilitation Bicompartmental wide meniscectomy Total collateral ligament rupture full thickness cartilage lesions 9) History of rheumatoid arthritis or similar rheumatic diseases 10) The discovery of rheumatoid arthritis, rheumatoid arthritis pigment villonodular synovitis and other joint diseases during the postoperative follow-up period may impair the ability to participate in the study 11) Unable to speak/understand the research content, lack of autonomy, unable to walk, or unable to participate in follow-up 12) Participate in any drug trials during and after the disease 13) Any other medical condition that considers the longest survival time to be less than 2 years 14) Immunodeficiency or HIV positive 15) Illegal drug use or chronic alcoholism or total daily alcohol intake \> 50 g/d 16) Pregnancy/planning pregnancy 17) There are contraindications such as current or previous history of neurological disease, cerebrovascular and serious cardiovascular disease, including coronary heart disease (angina pectoris, myocardial infarction, coronary angiogenesis process or abnormal electrocardiogram Q wave appearance (ECG)), Stroke (ischemic or hemorrhagic, including transient ischemic attack), peripheral arterial disease diagnosed by angiography 18) No imaging diagnosis 19) History of deep vein thrombosis (DVT) or blood system 20) There is a systemic disease that affects physical function, or there is any other condition or treatment that prevents the completion of the trial, including patients with metal devices or movement disorders

Primary outcomes:
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
timeFrame: At 6 months after intervention.
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
timeFrame: At 12 months after intervention.
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
timeFrame: At 24 months after intervention.
measure: Quadriceps strength
timeFrame: At 24months after intervention.
measure: Knee laxity （physical exam）
timeFrame: At 24months after intervention.
measure: Knee laxity （KT-2000 arthrometer）
timeFrame: At 24months after intervention.
measure: Magnetic resonance imaging (MRI)
timeFrame: At 24months after intervention.
Secondary outcomes:
measure: Gender
timeFrame: At baseline.
measure: Age
timeFrame: At baseline
measure: BMI
timeFrame: At baseline
measure: Single-Legged Hop Test
timeFrame: At 6 months after intervention.
measure: Single-Legged Hop Test
timeFrame: At 12 months after intervention.
measure: Single-Legged Hop Test
timeFrame: At 24 months after intervention.
measure: Triple hop test
timeFrame: At 6 months after intervention.
measure: Triple hop test
timeFrame: At 12 months after intervention.
measure: Triple hop test
timeFrame: At 24 months after intervention.
measure: Cross hop test
timeFrame: At 6 months after intervention.
measure: Cross hop test
timeFrame: At 12 months after intervention.
measure: Cross hop test
timeFrame: At 24 months after intervention.
measure: 6-m hop test
timeFrame: At 6 months after intervention.
measure: 6-m hop test
timeFrame: At 12 months after intervention.
measure: 6-m hop test
timeFrame: At 24 months after intervention.
measure: Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
timeFrame: At 6 months after intervention.
measure: Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
timeFrame: At 12 months after intervention.
measure: Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
timeFrame: At 24 months after intervention.
measure: Knee laxity
timeFrame: At 12 months after intervention.
measure: Knee laxity
timeFrame: At 6 months after intervention.
measure: Quadriceps strength
timeFrame: At 6 months after intervention.
measure: Quadriceps strength
timeFrame: At 12 months after intervention.
measure: Lysholm score
timeFrame: At 6 months after intervention.
measure: Lysholm score
timeFrame: At 12 months after intervention.
measure: Lysholm score
timeFrame: At 24 months after intervention.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At 6 months after intervention.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At 12 months after intervention.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At 24 months after intervention.
measure: Tegner Score
timeFrame: At 6 months after intervention.
measure: Tegner Score
timeFrame: At 12 months after intervention.
measure: Tegner Score
timeFrame: At 24 months after intervention.
measure: hort Form (SF)-36,The medical outcome study 36-items short form health survey (SF-36)
timeFrame: At 6 months after intervention.
measure: Magnetic resonance imaging (MRI)
timeFrame: At 6 months after intervention.
measure: Magnetic resonance imaging (MRI)
timeFrame: At 12 months after intervention.
measure: Knee laxity （KT-2000 arthrometer）
timeFrame: At 6 months after intervention.
measure: Knee laxity （KT-2000 arthrometer）
timeFrame: At 12 months after intervention.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine, Peking University Third Hospital
state: Beijing
Study officials:
References:
citation: Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. Am J Sports Med. 2006 Jan;34(1):128-35. doi: 10.1177/0363546505280214. Epub 2005 Oct 11.