This clinical trial compared the prognosis of surgical and non-surgical treatment in patients with complete anterior cruciate ligament rupture
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Conservative treatment is required to use a curved splint for 6 weeks to keep the feet on the ground, bathing and sleeping without loosening the utensils and taking no steroids during the period. Physical examination and magnetic resonance imaging were performed after 6 weeks. If laxity remained unsatisfactory, the outcome was recorded as failure and surgery was changed.
The patient underwent knee arthroscopic anterior cruciate ligament surgery at the Institute of Sports Medicine of the Third Hospital of Peking University. The surgical methods were all anatomical single-bundle.
Institute of Sports Medicine, Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGInternational Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
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.
Time frame: At 6 months after intervention.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
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.
Time frame: At 12 months after intervention.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
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.
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Time frame: At 24 months after intervention.
Quadriceps strength
Side to side quadriceps strength assessed by Biodex arthrometer test
Time frame: At 24months after intervention.
Knee laxity （physical exam）
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.
Time frame: At 24months after intervention.
Knee laxity （KT-2000 arthrometer）
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.
Time frame: At 24months after intervention.
Magnetic resonance imaging (MRI)
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.
Time frame: At 24months after intervention.
Gender
Measuring whether gender is a risk factor for anterior cruciate ligament reconstruction failure.
Time frame: At baseline.
Age
Measuring whether age is a risk factor for anterior cruciate ligament reconstruction failure
Time frame: At baseline
BMI
Weight and height will be combined to report BMI in kg/m\^2. Measuring whether bmi is a risk factor for anterior cruciate ligament reconstruction failure
Time frame: At baseline
Single-Legged Hop Test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Time frame: At 6 months after intervention.
Single-Legged Hop Test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Time frame: At 12 months after intervention.
Single-Legged Hop Test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Time frame: At 24 months after intervention.
Triple hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Time frame: At 6 months after intervention.
Triple hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Time frame: At 12 months after intervention.
Triple hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Time frame: At 24 months after intervention.
Cross hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
Time frame: At 6 months after intervention.
Cross hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
Time frame: At 12 months after intervention.
Cross hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
Time frame: At 24 months after intervention.
6-m hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
Time frame: At 6 months after intervention.
6-m hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
Time frame: At 12 months after intervention.
6-m hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
Time frame: At 24 months after intervention.
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Time frame: At 6 months after intervention.
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Time frame: At 12 months after intervention.
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Time frame: At 24 months after intervention.
Knee laxity
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.
Time frame: At 12 months after intervention.
Knee laxity
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.
Time frame: At 6 months after intervention.
Quadriceps strength
Side to side quadriceps strength assessed by Biodex arthrometer test
Time frame: At 6 months after intervention.
Quadriceps strength
Side to side quadriceps strength assessed by Biodex arthrometer test
Time frame: At 12 months after intervention.
Lysholm score
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time frame: At 6 months after intervention.
Lysholm score
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time frame: At 12 months after intervention.
Lysholm score
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time frame: At 24 months after intervention.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time frame: At 6 months after intervention.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time frame: At 12 months after intervention.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time frame: At 24 months after intervention.
Tegner Score
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Time frame: At 6 months after intervention.
Tegner Score
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Time frame: At 12 months after intervention.
Tegner Score
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Time frame: At 24 months after intervention.
hort Form (SF)-36,The medical outcome study 36-items short form health survey (SF-36)
Patients will be asked to fill out the SF-36 to document the quality of life . General health-related quality of life: SF-36 physical component score (range 0 to 100; higher score = better health state) at 2 yearsTh minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time frame: At 6 months after intervention.
Magnetic resonance imaging (MRI)
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.
Time frame: At 6 months after intervention.
Magnetic resonance imaging (MRI)
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.
Time frame: At 12 months after intervention.
Knee laxity （KT-2000 arthrometer）
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.
Time frame: At 6 months after intervention.
Knee laxity （KT-2000 arthrometer）
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.
Time frame: At 12 months after intervention.