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

NCT05403905 | Unknown

• 1 other identifier: IRB00006761-M2022073
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anterior Cruciate Ligament Rupture; Osteoarthritis, Knee

Keywords

Anterior cruciate ligament (ACL); OA; non-surgical treatment; rehabilitation

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• Quadriceps strength

  Side to side quadriceps strength assessed by Biodex arthrometer test

  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.

  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.

  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.

  At 24months after intervention.

Secondary Outcomes (36)

• Gender

  At baseline.

• Age

  At baseline

• BMI

  At baseline

• Single-Legged Hop Test

  At 6 months after intervention.

• Single-Legged Hop Test

  At 12 months after intervention.

Study Arms (2)

non-surgical treatment

EXPERIMENTAL

The patient who was diagnosed with complete rupture of the ACL in the Institute of Sports Medicine of the Third Hospital of Peking University was informed by the doctor that there is a chance that the ACL may grow back after 6 weeks of strict bracing.

Procedure: non surgical treatment

surgical treatment

ACTIVE COMPARATOR

The patient who was diagnosed with complete rupture of the ACL in the Institute of Sports Medicine of the Third Hospital of Peking University was informed by the doctor that there is a chance that after 6 weeks of strict brace immobilization, the ACL may grow back without surgery. However, the choice was still made for immediate ACL reconstruction. This group of patients underwent anterior cruciate ligament reconstruction surgery in the Third Hospital of Peking University.

Procedure: surgical treatment

Interventions

non surgical treatment PROCEDURE

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.

non-surgical treatment

surgical treatment PROCEDURE

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.

surgical treatment

Eligibility Criteria

• Age: 8 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Institute of Sports Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related 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. doi: 10.1177/0363546505280214. Epub 2005 Oct 11.

  PMID: 16219941 RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Osteoarthritis, Knee

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: June 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)