the Posterolateral Structure of the Knee JointNCT04461431
Clinical Study of Posterolateral Structure of Knee Joint Under Arthroscopy
A study testing Arthroscopic anatomical reconstruction of the posterolateral structure of the knee in people with the Posterolateral Structure of the Knee Joint and Arthroscopy, run by Peking University Third Hospital at 1 site in China.
Trial summary
Objective: To study the clinical effect of anatomical reconstruction of the posterolateral structure of the knee joint under arthroscopy. Methods: The patients who were admitted to hospital for the treatment of posterolateral structural injuries of the knee joint, including those with other ligament injuries (combined… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- the Posterolateral Structure of the Knee Joint, Arthroscopy, Anatomical Reconstruction
- What is being tested?
- Arthroscopic anatomical reconstruction of the posterolateral structure of the knee
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jan 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age <70 years old
- Those without avulsion of the affected biceps femoris tendon or iliac tibial bundle
- Those without avulsion fracture of the fibular stop of the lateral collateral ligament
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
Beijing, Beijing Municipality, 100191
Ping Liu
About this study
Official title: Clinical Study of Anatomical Reconstruction Technique of Posterolateral Structure of Knee Joint Under Arthroscopy
Objective: To study the clinical effect of anatomical reconstruction of the posterolateral structure of the knee joint under arthroscopy.
Methods: The patients who were admitted to hospital for the treatment of posterolateral structural injuries of the knee joint, including those with other ligament injuries (combined with anterior and posterior cruciate ligament injuries and medial collateral ligament injuries) were subjected to arthroscopic reconstruction of the posterolateral structures. Carry out preoperative and postoperative evaluations, and conduct preoperative and postoperative comparative studies to clarify the clinical effect of the procedure.
Read more
Expected results: The anatomical reconstruction technique of the posterolateral structure of the knee joint under arthroscopy may effectively restore the stability and motor function of the knee joint.
Expected conclusion: Arthroscopic anatomical reconstruction of the posterolateral structure of the knee is an effective minimally invasive technique.
- Being tested
- Arthroscopic anatomical reconstruction of the posterolateral structure of the knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic anatomical reconstruction of the posterolateral structure of the kneeProcedure or surgery
Arthroscopic anatomical reconstruction of the posterolateral structure of the knee for patients with injury of the posterolateral structure of the knee
| Study group | Role | What they receive |
|---|---|---|
| Knee joint lateral reconstruction group | Experimental | Not described Receives: Procedure: Arthroscopic anatomical reconstruction of the posterolateral structure of the knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
KT2000
Using KT2000 to detect the backward stability of the knee joint after operation, and compare it with the healthy leg
Measured: 1 year after operation
Lysholm
The Lysholm score consists of eight items including limping, locking, pain, stair climbing, use of supports, instability, swelling, and squatting. The higher values represent a better outcome.
Measured: 1 year after operation
Tegner
The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome.
Measured: 1 year after operation
IKDC
International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.
Measured: 1 year after operation
Secondary outcomes (1)
MRI
Using MRI to exam the healing of the posterolateral ligament reconstructed 1 year after surgery
Measured: 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Jan 2020
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Posterolateral Structure of the Knee JointStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461431
- Sponsor's protocol ID
- 2014185
- Status last verified
- Jul 2020
- First submitted
- 26 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Anatomical Reconstruction Technique of Posterolateral Structure of Knee Joint Under Arthroscopy
- ClinicalTrials.gov ID
- NCT04461431
- Acronym / sponsor ID
- 2014185
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 8 Jul 2020 (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.
Objective: To study the clinical effect of anatomical reconstruction of the posterolateral structure of the knee joint under arthroscopy.
Methods: The patients who were admitted to hospital for the treatment of posterolateral structural injuries of the knee joint, including those with other ligament injuries (combined with anterior and posterior cruciate ligament injuries and medial collateral ligament injuries) were subjected to arthroscopic reconstruction of the posterolateral structures. Carry out preoperative and postoperative evaluations, and conduct preoperative and postoperative comparative studies to clarify the clinical effect of the procedure.
Expected results: The anatomical reconstruction technique of the posterolateral structure of the knee joint under arthroscopy may effectively restore the stability and motor function of the knee joint.
Expected conclusion: Arthroscopic anatomical reconstruction of the posterolateral structure of the knee is an effective minimally invasive technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee joint lateral reconstruction group | Experimental | Procedure: Arthroscopic anatomical reconstruction of the posterolateral structure of the knee |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age <70 years old
- Those without avulsion of the affected biceps femoris tendon or iliac tibial bundle
- Those without avulsion fracture of the fibular stop of the lateral collateral ligament
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic anatomical reconstruction of the posterolateral structure of the kneeArthroscopic anatomical reconstruction of the posterolateral structure of the knee for patients with injury of the posterolateral structure of the knee | Procedure or surgery | Knee joint lateral reconstruction group |
Primary outcome
KT2000
Time frame: 1 year after operation
Using KT2000 to detect the backward stability of the knee joint after operation, and compare it with the healthy leg
Lysholm
Time frame: 1 year after operation
The Lysholm score consists of eight items including limping, locking, pain, stair climbing, use of supports, instability, swelling, and squatting. The higher values represent a better outcome.
Tegner
Time frame: 1 year after operation
The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome.
IKDC
Time frame: 1 year after operation
International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.
1 secondary outcome
MRI
Time frame: 1 year after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic anatomical reconstruction of the posterolateral structure of the knee in people with the Posterolateral Structure of the Knee Joint and Arthroscopy, 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 3 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 8 Jul 2020. 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 Ping Liu (13683670396, bjusm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KT2000 (time frame: 1 year after operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2020.