Study of Meniscal Allografts

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01059409
• Date of registration: 28/01/2010
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Study of Meniscal Allografts ERAM
• Scientific title: The Clinical and Medico-economical Evaluation of Meniscal Allografts in the Sequelae of Total or Sub-total Meniscectomy.
• Date of first enrolment: September 2010
• Target sample size: 23
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01059409
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Patricia THOREUX, MD,PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age from 18 on

- Previous total or subtotal meniscectomy

- Medical insurance

- Female patients have to be under contraceptive treatment

- Sign consent form

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Meniscectomy Sequelae

Intervention(s)

Procedure: Meniscal Allograft

Primary Outcome(s)

"Function" Subscale in the Koos Scale (area under the curve) [Time Frame: 2 years follow up]

Secondary Outcome(s)

Post operative and late complications [Time Frame: At 2 years follow-up]

Clinical criteria: pain, quality of life, professional activity [Time Frame: At 2 years follow-up]

Secondary ID(s)

P070309 / IC0705

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ministry of Health, France