A Cohort Study of Non-surgical Treatment and Exercise Rehabilitation in Patients -Chinese Population-based Cohort
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anterior Cruciate Ligament Rupture
- Sponsor
- Peking University Third Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •The reason for the rupture of the anterior cruciate ligament is sports trauma.
- •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.
- •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
- •Used in the previous 12 months
- •Intra-articular injection
- •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
Outcomes
Primary Outcomes
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Time Frame: At 12 months after intervention.
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.The role of IKDC2000 is not only to compare the prognosis of the knee joint between the surgical group and the non-surgical group, but also to the normal population we mentioned in the article according to The International Knee Documentation Committee Subjective Knee Evaluation Form Normative Data Allen F. Anderson,\*† AJSM The IKDC2000 values of different genders and ages were used to judge whether the two groups of patients reached the standard of normal people after surgery.
Knee laxity （KT-2000 arthrometer）
Time Frame: At 24months after intervention.
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) \< - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) \> 5 mm. The back-pushing KT-2000 is also divided into side to side differences as (A) \< - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) \> 1 mm.
Knee laxity （physical exam）
Time Frame: At 24months after intervention.
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1\~2mm(0+), grade B: 3\~5mm (1+), grade C: 6\~10mm (2+) and D Grade: \>10mm(3+) assessed by Lachman test of physical examination.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Time Frame: At 24 months after intervention.
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.The role of IKDC2000 is not only to compare the prognosis of the knee joint between the surgical group and the non-surgical group, but also to the normal population we mentioned in the article according to The International Knee Documentation Committee Subjective Knee Evaluation Form Normative Data Allen F. Anderson,\*† AJSM The IKDC2000 values of different genders and ages were used to judge whether the two groups of patients reached the standard of normal people after surgery.
Quadriceps strength
Time Frame: At 24months after intervention.
Side to side quadriceps strength assessed by Biodex arthrometer test
Magnetic resonance imaging (MRI)
Time Frame: At 24months after intervention.
Magnetic resonance imaging was used to compare lateral comparisons of ligament healing and ACL graft healing after conservative treatment, meniscal damage and knee cartilage damage after intervention.
Secondary Outcomes
- Age(At baseline)
- BMI(At baseline)
- Cross hop test(At 24 months after intervention.)
- Gender(At baseline.)
- 6-m hop test(At 24 months after intervention.)
- Tegner Score(At 24 months after intervention.)
- Triple hop test(At 24 months after intervention.)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(At 24 months after intervention.)
- Knee laxity （KT-2000 arthrometer）(At 12 months after intervention.)
- hort Form (SF)-36,The medical outcome study 36-items short form health survey (SF-36)(At 6 months after intervention.)
- Single-Legged Hop Test(At 24 months after intervention.)
- Magnetic resonance imaging (MRI)(At 12 months after intervention.)
- Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale(At 24 months after intervention.)
- Knee laxity(At 6 months after intervention.)
- Quadriceps strength(At 12 months after intervention.)
- Lysholm score(At 24 months after intervention.)