NCT03932838

Brief Summary

Evaluation of clinical results and postoperative laxity after single-stage reconstruction of multiligamentous lesions of the knee. Comparison of two types of transplant: allograft versus autograft. There is currently little data in the clinical outcome literature after allograft reconstruction. There is one study reporting postoperative laxity assessed by dynamic radiography in the four planes (anterior, posterior, varus, valgus). No study compares postoperative laxity after allograft versus autograft reconstruction.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
110mo left

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress48%
Dec 2017Jun 2035

Study Start

First participant enrolled

December 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
15.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2035

Expected
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

April 12, 2019

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Joint mobility of both knees

    Postoperative knee function assessed by clinical examination

    2 years

  • Postoperative laxity in varus, valgus, anterior and posterior drawer

    Postoperative knee function assessed by clinical examination

    2 years

  • Postoperative knee function assessed by scores

    2 years

Study Arms (1)

clinical and radiologic evaluation

EXPERIMENTAL

Follow up post surgery: clinical and radiologic evaluation

Other: Clinical and radiologic evaluation

Interventions

Follow up post surgery: clinical and radiologic evaluation

clinical and radiologic evaluation

Eligibility Criteria

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

You may qualify if:

  • Patients operated for one-time allograft or autograft reconstruction of multiligamentous knee injury
  • \>18 years old

You may not qualify if:

  • Neurological or vascular injury during trauma.
  • Fracture of the femur or both bones of the leg.
  • Ligamentous lesion on the contralateral knee.
  • History of surgery on the affected knee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH de Versailles

Le Chesnay, France

RECRUITING

MeSH Terms

Conditions

Knee Injuries

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigateur

Study Record Dates

First Submitted

April 12, 2019

First Posted

May 1, 2019

Study Start

December 1, 2017

Primary Completion

December 1, 2019

Study Completion (Estimated)

June 1, 2035

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations