The ACL RuptureNCT04455516
Meniscus Repair With Simultaneous ACL Reconstruction: Clinical Outcomes，Failure Rates And Subsequent Processing
An observational study of The ACL Rupture and Meniscus Injury, run by Peking University Third Hospital at 1 site in China.
Trial summary
Our study has explored the causes of failure of meniscus repair and investigated the clinical effects of partial meniscectomy when meniscus repair failed. Read more about this study
- Who is it for?
- Ages 13 to 60 years
- Conditions the study is for
- The ACL Rupture, Meniscus Injury
- What is being tested?
- Meniscus repair; partial meniscectomy
- Type of treatment
- Surgery or procedure
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2020to 16 May 2020
- 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 13 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This retrospective case series was conducted to evaluate the clinical outcomes and failure rates of primary meniscus repair with simultaneous ACL reconstruction in patients who were operated by the same physician at our institution.
Who may be able to join
- patients with intraoperatively confirmed ACL rupture combined with medial, lateral, or medial and lateral meniscal injury;
- age <60 years
- no history of previous ipsilateral knee meniscal injury.
Who cannot join
- ACL rupture associated with fracture, collateral ligament injury, or complex ligament injury;
- a history of knee surgery;
- a significant degree of osteoarthritis.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Our study has explored the causes of failure of meniscus repair and investigated the clinical effects of partial meniscectomy when meniscus repair failed.
Read the detailed description
Background: Meniscus repair performed during ACL reconstruction may fail and the subsequent treatment includes revision meniscal repair or partial meniscectomy.
Purpose: To retrospectively analyze the clinical outcomes of meniscus repair with simultaneous anterior cruciate ligament (ACL) reconstruction and explore the causes of failure of meniscus repair.
Methods: From May 2013 to July 2018, the clinical data of 165 patients who were treated with meniscus surgery and simultaneous ACL reconstruction by the same doctor, including 69 cases of meniscus repair (repair group) and 96 cases of partial meniscectomy (partial meniscectomy group), were retrospectively analyzed. The 69 patients of the repair group were divided into the nonfailure group (62 cases) and the failure group (7 cases) depending on the repair effect. The average follow-up period was 38 (±10.5) months. Postoperative outcomes of the repair group and the partial meniscectomy group were compared. General conditions and postoperative outcomes of the failure group and the nonfailure group were compared. Seven patients in the failure group who underwent second arthroscopy were followed up for 30 (±17.4) months, and their postoperative outcomes were summarized.
- Conditions
- The ACL Rupture, Meniscus Injury
- Being tested
- Meniscus repair; partial meniscectomy
- Keywords
- meniscus, failure of repair, anterior cruciate ligament reconstruction, arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meniscus repair; partial meniscectomyProcedure or surgery
69 cases of meniscus repair (repair group) and 96 cases of partial meniscectomy (partial meniscectomy group), were retrospectively analyzed. The 69 patients of the repair group were divided into the nonfailure group (62 cases) and the failure group (7 cases) depending on the repair effect.
| Study group | Role | What they receive |
|---|---|---|
| repair group | The first operation in these patients was meniscus repair Receives: Procedure: Meniscus repair; partial meniscectomy | |
| nonfailure group | These patients had a successful first operation Receives: Procedure: Meniscus repair; partial meniscectomy | |
| failure group | In these patients, the first meniscus repair operation failed Receives: Procedure: Meniscus repair; partial meniscectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The result of partial meniscus resection
Clinical signs were assessed after the surgery, including swelling of the joint, tenderness at the joint line, locked-in syndrome, and positive McMurray's sign.
Measured: Two years after the surgery
International Knee Documentation Committee（IKDC）scores
The minimum is 0, the maximum is 100, and the higher the score, the better the result
Measured: Two years after the surgery
Visual analog scale (VAS) scores
The minimum is 0, the maximum is 10, and the higher the score, the worse the result
Measured: Two years after the surgery
Lysholm scores
The minimum is 0, the maximum is 100, and the higher the score, the better the result
Measured: Two years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start16 Mar 2020
- Primary completion16 Apr 2020
- Study completion16 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The ACL 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 165 participants (actual)
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
- NCT04455516
- Sponsor's protocol ID
- M2020024
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meniscus Repair With Simultaneous ACL Reconstruction: Clinical Outcomes，Failure Rates And Subsequent Processing
- ClinicalTrials.gov ID
- NCT04455516
- Acronym / sponsor ID
- M2020024
- Conditions
- The ACL Rupture, Meniscus Injury
- Keywords
- meniscus, failure of repair, anterior cruciate ligament reconstruction, arthroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 16 May 2020 (actual)
- First posted
- 2 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.
Our study has explored the causes of failure of meniscus repair and investigated the clinical effects of partial meniscectomy when meniscus repair failed.
Detailed description
Background: Meniscus repair performed during ACL reconstruction may fail and the subsequent treatment includes revision meniscal repair or partial meniscectomy.
Purpose: To retrospectively analyze the clinical outcomes of meniscus repair with simultaneous anterior cruciate ligament (ACL) reconstruction and explore the causes of failure of meniscus repair.
Methods: From May 2013 to July 2018, the clinical data of 165 patients who were treated with meniscus surgery and simultaneous ACL reconstruction by the same doctor, including 69 cases of meniscus repair (repair group) and 96 cases of partial meniscectomy (partial meniscectomy group), were retrospectively analyzed. The 69 patients of the repair group were divided into the nonfailure group (62 cases) and the failure group (7 cases) depending on the repair effect. The average follow-up period was 38 (±10.5) months. Postoperative outcomes of the repair group and the partial meniscectomy group were compared. General conditions and postoperative outcomes of the failure group and the nonfailure group were compared. Seven patients in the failure group who underwent second arthroscopy were followed up for 30 (±17.4) months, and their postoperative outcomes were summarized.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| repair group | – | Procedure: Meniscus repair; partial meniscectomyThe first operation in these patients was meniscus repair |
| nonfailure group | – | Procedure: Meniscus repair; partial meniscectomyThese patients had a successful first operation |
| failure group | – | Procedure: Meniscus repair; partial meniscectomyIn these patients, the first meniscus repair operation failed |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This retrospective case series was conducted to evaluate the clinical outcomes and failure rates of primary meniscus repair with simultaneous ACL reconstruction in patients who were operated by the same physician at our institution.
Key inclusion criteria (3 listed)
- patients with intraoperatively confirmed ACL rupture combined with medial, lateral, or medial and lateral meniscal injury;
- age <60 years
- no history of previous ipsilateral knee meniscal injury.
Key exclusion criteria (3 listed)
- ACL rupture associated with fracture, collateral ligament injury, or complex ligament injury;
- a history of knee surgery;
- a significant degree of osteoarthritis.
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 |
|---|---|---|
| Meniscus repair; partial meniscectomy69 cases of meniscus repair (repair group) and 96 cases of partial meniscectomy (partial meniscectomy group), were retrospectively analyzed. The 69 patients of the repair group were divided into the nonfailure group (62 cases) and the failure group (7 cases) depending on the repair effect. | Procedure or surgery | failure group, nonfailure group, repair group |
Primary outcome
The result of partial meniscus resection
Time frame: Two years after the surgery
Clinical signs were assessed after the surgery, including swelling of the joint, tenderness at the joint line, locked-in syndrome, and positive McMurray's sign.
International Knee Documentation Committee（IKDC）scores
Time frame: Two years after the surgery
The minimum is 0, the maximum is 100, and the higher the score, the better the result
Visual analog scale (VAS) scores
Time frame: Two years after the surgery
The minimum is 0, the maximum is 10, and the higher the score, the worse the result
Lysholm scores
Time frame: Two years after the surgery
The minimum is 0, the maximum is 100, and the higher the score, the better the result
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for The ACL Rupture
Recruiting
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
ACL - Anterior Cruciate Ligament Rupture
Active, not recruiting
Over-the-Top vs. Anteromedial ACLR With Lateral Extraarticular Tenodesis
Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries
Recruiting
Comparison of Video Based Phone App vs. Supervised Preoperative Exercise for ACL Reconstruction
Anterior Cruciate Ligament (ACL) Rupture, Anterior Cruciate Ligament (ACL) Reconstruction
Not yet recruiting
Correlation Study Between the Classification of Arthrogenic Motor Inhibition (AMI) and Clinical Assessment After ACL Rupture
ACL - Anterior Cruciate Ligament Rupture
Recruiting
Microbiological Molecular Profile of the Knee Joint During Primary Reconstruction or Revision Surgery of the ACL
ACL - Anterior Cruciate Ligament Rupture
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.
The record lists no contact. Use the official record to reach the sponsor.
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 The ACL Rupture and Meniscus Injury, 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 3 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: finished, as of the sponsor's last update on 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The result of partial meniscus resection (time frame: Two years after the surgery). 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 7 Jul 2020.