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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04455516
Other study ID # M2020024
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 16, 2020
Est. completion date May 16, 2020

Study information

Verified date July 2020
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 165
Est. completion date May 16, 2020
Est. primary completion date April 16, 2020
Accepts healthy volunteers No
Gender All
Age group 13 Years to 60 Years
Eligibility Inclusion Criteria:

1. patients with intraoperatively confirmed ACL rupture combined with medial, lateral, or medial and lateral meniscal injury;

2. age <60 years

3. no history of previous ipsilateral knee meniscal injury.

Exclusion Criteria:

1. ACL rupture associated with fracture, collateral ligament injury, or complex ligament injury;

2. a history of knee surgery;

3. a significant degree of osteoarthritis.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Meniscus repair; partial meniscectomy
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.

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Two years after the surgery
Primary International Knee Documentation Committee(IKDC)scores The minimum is 0, the maximum is 100, and the higher the score, the better the result Two years after the surgery
Primary Visual analog scale (VAS) scores The minimum is 0, the maximum is 10, and the higher the score, the worse the result Two years after the surgery
Primary Lysholm scores 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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