NCT01059409

Brief Summary

Total or subtotal meniscectomies in young patients are currently responsible of pain and limitation of activities. There isn't any other treatment than meniscal replacement. But there is no randomized clinical trial on meniscal allograft to validate the efficiency of this treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

September 2, 2020

Status Verified

March 1, 2020

Enrollment Period

9.1 years

First QC Date

January 28, 2010

Last Update Submit

August 31, 2020

Conditions

Meniscectomy Sequelae

Keywords

Meniscal AllograftsOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • "Function" Subscale in the Koos Scale (area under the curve)

    Koos Scale

    2 years follow up

Secondary Outcomes (2)

  • Clinical criteria: pain, quality of life, professional activity

    At 2 years follow-up

  • Post operative and late complications

    At 2 years follow-up

Study Arms (1)

Meniscal Allograft

EXPERIMENTAL
Procedure: Meniscal Allograft

Interventions

Meniscal AllograftPROCEDURE

Meniscal Allograft

Meniscal Allograft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 18 on
  • Previous total or subtotal meniscectomy
  • Medical insurance
  • Female patients have to be under contraceptive treatment
  • Sign consent form

You may not qualify if:

  • Age \< 18 years
  • Pregnant or breast-feeding woman
  • Need of a simultaneous frontal osteotomy
  • Inflammatory disease
  • Septic background
  • Psychiatric background
  • Understanding difficulties or problems for follow-up
  • No consent
  • No medical insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

POTEL Jean-François, Clinique Medipole Garonne

Toulouse, 31036, France

Location

Hôpital Avicenne - Service de Chirurgie orthopédique

Bobigny, Île-de-France Region, 93009, France

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Patricia THOREUX, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2010

First Posted

January 29, 2010

Study Start

September 1, 2010

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

September 2, 2020

Record last verified: 2020-03

Locations

FR(2)