NCT04455516

Brief Summary

Our study has explored the causes of failure of meniscus repair and investigated the clinical effects of partial meniscectomy when meniscus repair failed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

June 25, 2020

Last Update Submit

July 1, 2020

Conditions

Keywords

meniscusfailure of repairanterior cruciate ligament reconstructionarthroscopy

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • Lysholm scores

    The minimum is 0, the maximum is 100, and the higher the score, the better the result

    Two years after the surgery

Study Arms (3)

repair group

The first operation in these patients was meniscus repair

Procedure: Meniscus repair; partial meniscectomy

nonfailure group

These patients had a successful first operation

Procedure: Meniscus repair; partial meniscectomy

failure group

In these patients, the first meniscus repair operation failed

Procedure: Meniscus repair; partial meniscectomy

Interventions

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 groupnonfailure grouprepair group

Eligibility Criteria

Age13 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • ACL rupture associated with fracture, collateral ligament injury, or complex ligament injury;
  • a history of knee surgery;
  • a significant degree of osteoarthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2020

First Posted

July 2, 2020

Study Start

March 16, 2020

Primary Completion

April 16, 2020

Study Completion

May 16, 2020

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations