- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04455516
Meniscus Repair With Simultaneous ACL Reconstruction: Clinical Outcomes,Failure Rates And Subsequent Processing
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100191
- Peking University Third Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- ACL rupture associated with fracture, collateral ligament injury, or complex ligament injury;
- a history of knee surgery;
- a significant degree of osteoarthritis.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
repair group
The first operation in these patients was meniscus repair
|
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.
|
nonfailure group
These patients had a successful first operation
|
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.
|
failure group
In these patients, the first meniscus repair operation failed
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Two years after the surgery
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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
|
Two years after the surgery
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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
|
Two years after the surgery
|
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
|
Two years after the surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2020024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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