Anterior Cruciate Ligament RuptureRCACLRNCT03984474
The Clinical Outcome of Anterior Cruciate Ligament Reconstruction
An observational study of Anterior Cruciate Ligament Rupture, run by Peking University Third Hospital at 1 site in China.
Trial summary
Retrospective cohort study. The investigators evaluated the early, middle and long term effects of different surgical methods of anterior cruciate ligament reconstruction on knee function. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2003to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with the anterior cruciate ligament reconstruction in the Peking University Third Hospital during 1999-2017.
Who may be able to join
- diagnosis of isolated anterior cruciate ligament rupture
Who cannot join
- combined other ligament damage combined intraarticular injuries
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Jia-Kuo Yu, Doctor, 86-10-82267392, yujiakuo@126.com
Zi-Mu Mao, Doctor, 8613716437053, mzm@pku.edu.cn
About this study
Official title: Institute of Sports Medicine of Peking University Third Hospital, Beijing, China
Retrospective cohort study. The investigators evaluated the early, middle and long term effects of different surgical methods of anterior cruciate ligament reconstruction on knee function.
In the evaluation, the investigators focused on the differences between different age groups, different genders and different basic motor states, the differences between early reconstruction and non-early reconstruction, and the differences in clinical outcomes of different surgical methods.
Read the detailed description
Age 13-65 included. Only include isolated anterior cruciate ligament(ACL) rupture. Excluded revision surgery. Excluded bilateral ACL rupture. Excluded the contralateral ACL tear after surgery. 40 patients at least in each group.
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Anterior Cruciate Ligament Reconstruction, Patient-reported outcome, Meniscus, Cartilage
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single bundle group | Age 13-65 when enrolled. Only include isolated ACL rupture. Excluded revision surgery. Excluded bilateral ACL rupture. Excluded the contralateral ACL tear after surgery. | |
| Double bundle group | Age 13-65 when enrolled. Only include isolated ACL rupture. Excluded revision surgery. Excluded bilateral ACL rupture. Excluded the contralateral ACL tear after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee(IKDC) score
The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.
Measured: Preoperative
International Knee Documentation Committee(IKDC) score
The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.
Measured: 2 years after surgery
International Knee Documentation Committee(IKDC) score
The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.
Measured: 5-8 years after surgery
International Knee Documentation Committee(IKDC) score
The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.
Measured: 10-15 years after surgery
International Knee Documentation Committee(IKDC) score
The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.
Measured: an average of 20 year
KT-2000 test
It is a kind of joint measuring instrument used to determine the anteroposterior stability of knee joint. The contrast between the uninjured side and the surgical measurement showed that the difference of ≤3mm was considered excellent.
Measured: 2 years after surgery
KT-2000 test
It is a kind of joint measuring instrument used to determine the anteroposterior stability of knee joint. The contrast between the uninjured side and the surgical measurement showed that the difference of ≤3mm was considered excellent.
Measured: 5-8 years after surgery
KT-2000 test
It is a kind of joint measuring instrument used to determine the anteroposterior stability of knee joint. The contrast between the uninjured side and the surgical measurement showed that the difference of ≤3mm was considered excellent.
Measured: 10-15 years after surgery
KT-2000 test
It is a kind of joint measuring instrument used to determine the anteroposterior stability of knee joint. The contrast between the uninjured side and the surgical measurement showed that the difference of ≤3mm was considered excellent.
Measured: an average of 20 year
Magnatic Resonance Imaging evaluation
All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).
Measured: Preoperative
Magnatic Resonance Imaging evaluation
All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).
Measured: 2 years after surgery
Magnatic Resonance Imaging evaluation
All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).
Measured: 5-8 years after surgery
Magnatic Resonance Imaging evaluation
All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).
Measured: 10-15 years after surgery
Magnatic Resonance Imaging evaluation
All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).
Measured: an average of 20 year
Secondary outcomes (5)
Skeletal force line and various angles by X-ray evaluation
X-ray was used to evaluate the skeletal force line and various angles of patients. Use Qvadriceps Angle to evaluate quadriceps force line and patellar ligament force line. The normal Angle is 18-22° for the adult standing position.Above or below this range is considered abnormal.
Measured: Preoperative
Skeletal force line and various angles by X-ray evaluation
X-ray was used to evaluate the skeletal force line and various angles of patients. Use Qvadriceps Angle to evaluate quadriceps force line and patellar ligament force line. The normal Angle is 18-22° for the adult standing position.Above or below this range is considered abnormal.
Measured: 2 years after surgery
Skeletal force line and various angles by X-ray evaluation
X-ray was used to evaluate the skeletal force line and various angles of patients. Use Qvadriceps Angle to evaluate quadriceps force line and patellar ligament force line. The normal Angle is 18-22° for the adult standing position.Above or below this range is considered abnormal.
Measured: 5-8 years after surgery
Skeletal force line and various angles by X-ray evaluation
X-ray was used to evaluate the skeletal force line and various angles of patients. Use Qvadriceps Angle to evaluate quadriceps force line and patellar ligament force line. The normal Angle is 18-22° for the adult standing position.Above or below this range is considered abnormal.
Measured: 10-15 years after surgery
Skeletal force line and various angles by X-ray evaluation
X-ray was used to evaluate the skeletal force line and various angles of patients. Use Qvadriceps Angle to evaluate quadriceps force line and patellar ligament force line. The normal Angle is 18-22° for the adult standing position.Above or below this range is considered abnormal.
Measured: an average of 20 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start14 Jan 2003
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Inner Mongolia People's Hospital, Peking Union Medical College Hospital
- Responsible party
- Principal investigator, Jia-kuo yu, Peking University Third Hospital
- Investigators
- Jia-Kuo Yu, Doctor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984474
- Sponsor's protocol ID
- ACLR-YJK
- Acronym
- RCACLR
- Status last verified
- Jun 2019
- First submitted
- 29 Apr 2019
- Last updated
- 13 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mao Z, Wang J, Wang Y, Jiang D, Wang X, Wang H, Lin L, Liu Y, Zeng L, Yu J. Double-bundle anterior cruciate ligament reconstruction technique has advantages in chondroprotection and knee laxity control compared with single-bundle technique : A long-term follow-up with a minimum of 12 years. Knee Surg Sports Traumatol Arthrosc. 2021 Sep;29(9):3105-3114. doi: 10.1007/s00167-020-06350-5. Epub 2020 Nov 20.
PubMed 33216188
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institute of Sports Medicine of Peking University Third Hospital, Beijing, China
- ClinicalTrials.gov ID
- NCT03984474
- Acronym / sponsor ID
- RCACLR / ACLR-YJK
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Anterior Cruciate Ligament Reconstruction, Patient-reported outcome, Meniscus, Cartilage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Inner Mongolia People's Hospital, Peking Union Medical College Hospital
- Study start
- 14 Jan 2003 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective cohort study. The investigators evaluated the early, middle and long term effects of different surgical methods of anterior cruciate ligament reconstruction on knee function.
In the evaluation, the investigators focused on the differences between different age groups, different genders and different basic motor states, the differences between early reconstruction and non-early reconstruction, and the differences in clinical outcomes of different surgical methods.
Detailed description
Age 13-65 included. Only include isolated anterior cruciate ligament(ACL) rupture. Excluded revision surgery. Excluded bilateral ACL rupture. Excluded the contralateral ACL tear after surgery. 40 patients at least in each group.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single bundle group | – | –Age 13-65 when enrolled. Only include isolated ACL rupture. Excluded revision surgery. Excluded bilateral ACL rupture. Excluded the contralateral ACL tear after surgery. |
| Double bundle group | – | –Age 13-65 when enrolled. Only include isolated ACL rupture. Excluded revision surgery. Excluded bilateral ACL rupture. Excluded the contralateral ACL tear after surgery. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with the anterior cruciate ligament reconstruction in the Peking University Third Hospital during 1999-2017.
Key inclusion criteria (1 listed)
- diagnosis of isolated anterior cruciate ligament rupture
Key exclusion criteria (1 listed)
- combined other ligament damage combined intraarticular injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
International Knee Documentation Committee(IKDC) score
Time frame: Preoperative
The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.
International Knee Documentation Committee(IKDC) score
Time frame: 2 years after surgery
The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.
International Knee Documentation Committee(IKDC) score
Time frame: 5-8 years after surgery
The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.
International Knee Documentation Committee(IKDC) score
Time frame: 10-15 years after surgery
The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.
International Knee Documentation Committee(IKDC) score
Time frame: an average of 20 year
The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.
KT-2000 test
Time frame: 2 years after surgery
It is a kind of joint measuring instrument used to determine the anteroposterior stability of knee joint. The contrast between the uninjured side and the surgical measurement showed that the difference of ≤3mm was considered excellent.
KT-2000 test
Time frame: 5-8 years after surgery
It is a kind of joint measuring instrument used to determine the anteroposterior stability of knee joint. The contrast between the uninjured side and the surgical measurement showed that the difference of ≤3mm was considered excellent.
KT-2000 test
Time frame: 10-15 years after surgery
It is a kind of joint measuring instrument used to determine the anteroposterior stability of knee joint. The contrast between the uninjured side and the surgical measurement showed that the difference of ≤3mm was considered excellent.
KT-2000 test
Time frame: an average of 20 year
It is a kind of joint measuring instrument used to determine the anteroposterior stability of knee joint. The contrast between the uninjured side and the surgical measurement showed that the difference of ≤3mm was considered excellent.
Magnatic Resonance Imaging evaluation
Time frame: Preoperative
All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).
Magnatic Resonance Imaging evaluation
Time frame: 2 years after surgery
All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).
Magnatic Resonance Imaging evaluation
Time frame: 5-8 years after surgery
All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).
Magnatic Resonance Imaging evaluation
Time frame: 10-15 years after surgery
All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).
Magnatic Resonance Imaging evaluation
Time frame: an average of 20 year
All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).
5 secondary outcomes
Skeletal force line and various angles by X-ray evaluation
Time frame: Preoperative
Skeletal force line and various angles by X-ray evaluation
Time frame: 2 years after surgery
Skeletal force line and various angles by X-ray evaluation
Time frame: 5-8 years after surgery
Skeletal force line and various angles by X-ray evaluation
Time frame: 10-15 years after surgery
Skeletal force line and various angles by X-ray evaluation
Time frame: an average of 20 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Derived from this study: PubMed 33216188Mao Z, Wang J, Wang Y, Jiang D, Wang X, Wang H, Lin L, Liu Y, Zeng L, Yu J. Double-bundle anterior cruciate ligament reconstruction technique has advantages in chondroprotection and knee laxity control compared with single-bundle technique : A long-term follow-up with a minimum of 12 years. Knee Surg Sports Traumatol Arthrosc. 2021 Sep;29(9):3105-3114. doi: 10.1007/s00167-020-06350-5. Epub 2020 Nov 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia-Kuo Yu, Doctor study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Rupture, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia-Kuo Yu, Doctor (861082267392, yujiakuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee(IKDC) score (time frame: Preoperative). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03984474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.