A Cohort Study of Non-surgical Treatment and Exercise Rehabilitation in Patients With Anterior Cruciate Ligament Rupture

Osteoarthritis, Knee Clinical Trial

Official title:

A Cohort Study of Non-surgical Treatment and Exercise Rehabilitation in Patients -Chinese Population-based Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05403905
• Other study ID #: IRB00006761-M2022073
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2022
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Osteoarthritis, Knee
• Rupture

Intervention

Procedure:
• non surgical treatment
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.
• surgical treatment
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.

Locations

Country	Name	City	State
China	Institute of Sports Medicine, Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Epub 2005 Oct 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 6 months after intervention.
Primary	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.	At 12 months after intervention.
Primary	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.	At 24 months after intervention.
Primary	Quadriceps strength	Side to side quadriceps strength assessed by Biodex arthrometer test	At 24months after intervention.
Primary	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.	At 24months after intervention.
Primary	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.	At 24months after intervention.
Primary	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.	At 24months after intervention.
Secondary	Gender	Measuring whether gender is a risk factor for anterior cruciate ligament reconstruction failure.	At baseline.
Secondary	Age	Measuring whether age is a risk factor for anterior cruciate ligament reconstruction failure	At baseline
Secondary	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	At baseline
Secondary	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.	At 6 months after intervention.
Secondary	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.	At 12 months after intervention.
Secondary	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.	At 24 months after intervention.
Secondary	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.	At 6 months after intervention.
Secondary	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.	At 12 months after intervention.
Secondary	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.	At 24 months after intervention.
Secondary	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.	At 6 months after intervention.
Secondary	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.	At 12 months after intervention.
Secondary	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.	At 24 months after intervention.
Secondary	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.	At 6 months after intervention.
Secondary	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.	At 12 months after intervention.
Secondary	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.	At 24 months after intervention.
Secondary	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	At 6 months after intervention.
Secondary	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	At 12 months after intervention.
Secondary	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	At 24 months after intervention.
Secondary	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.	At 12 months after intervention.
Secondary	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.	At 6 months after intervention.
Secondary	Quadriceps strength	Side to side quadriceps strength assessed by Biodex arthrometer test	At 6 months after intervention.
Secondary	Quadriceps strength	Side to side quadriceps strength assessed by Biodex arthrometer test	At 12 months after intervention.
Secondary	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.	At 6 months after intervention.
Secondary	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.	At 12 months after intervention.
Secondary	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.	At 24 months after intervention.
Secondary	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.	At 6 months after intervention.
Secondary	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.	At 12 months after intervention.
Secondary	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.	At 24 months after intervention.
Secondary	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.	At 6 months after intervention.
Secondary	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.	At 12 months after intervention.
Secondary	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.	At 24 months after intervention.
Secondary	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.	At 6 months after intervention.
Secondary	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.	At 6 months after intervention.
Secondary	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.	At 12 months after intervention.
Secondary	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.	At 6 months after intervention.
Secondary	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.	At 12 months after intervention.