Study of Meniscal Allografts

Meniscectomy Sequelae Clinical Trial

— ERAM  

Official title:

The Clinical and Medico-economical Evaluation of Meniscal Allografts in the Sequelae of Total or Sub-total Meniscectomy.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01059409
• Other study ID #: P070309 / IC0705
• Status: Terminated
• Phase: N/A
• Start date: September 2010
• Est. completion date: September 30, 2019

Study information

• Verified date: March 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Meniscal allograft is done through United States and Europe since the last fifteen years. Operative technique has regularly improved, especially because of new arthroscopic devices. The meniscal allografts to be used are taken from dead donors and then frozen according to all the reglementary aspects of tissue bank.

The graft has to be ordered as soon as the patient is randomized ; the sizing of the graft ordered is important depending on the gender size and height of the patient and on the measures of the tibial plateau on X Rays.

The arthroscopic procedure is done under general or loco-regional anesthesia. The graft has to be prepared with bone blocks attached to the anterior and posterior horn of the meniscal graft. These bone blocks will be fixed through bone tunnels and the meniscus itself will be sutured on the peripheral meniscus synovial rim.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meniscectomy Sequelae

Intervention

Procedure:
• Meniscal Allograft
Meniscal Allograft

Locations

Country	Name	City	State
France	Hôpital Avicenne - Service de Chirurgie orthopédique	Bobigny	Ile De France
France	POTEL Jean-François, Clinique Medipole Garonne	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Function" Subscale in the Koos Scale (area under the curve)	Koos Scale	2 years follow up
Secondary	Clinical criteria: pain, quality of life, professional activity	Pain, quality of life, professional activity	At 2 years follow-up
Secondary	Post operative and late complications	Post operative complications	At 2 years follow-up