NCT04210440

Brief Summary

This retrospective study evaluates 52 cases of avascular necrosis of femoral head (AVN) treated by core decompression, bone chips allograft, fibrin platelet rich-plasma (PRF) and concentrated autologous mesenchymal stromal cells (MSCs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

8 years

First QC Date

December 21, 2019

Last Update Submit

December 21, 2019

Conditions

Hip NecrosisHip Injuries

Keywords

hip avascular necrosiship conservative surgery

Outcome Measures

Primary Outcomes (1)

  • Avoiding arthroplasty

    The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR)

    24 months after surgery

Secondary Outcomes (4)

  • Harris Hip Score

    6 weeks after surgery

  • Harris Hip Score

    3 months after surgery

  • Harris Hip Score

    6 months after surgery

  • Harris Hip Score

    12 months after surgery

Study Arms (1)

Hip avascular necrosis

EXPERIMENTAL

patients affected by avascular necrosis of the Hip classified by Japanese Investigation Committee criteria

Procedure: Core decompression procedure

Interventions

Core decompression procedurePROCEDURE

Core Decompression with Bone Chips Allograft adjuvanted by Fibrin Platelet Rich-plasma (PRP) and Concentrated Autologous Mesenchymal Stromal Cells (MSCS), isolated from Bone Marrow

Hip avascular necrosis

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- hip avascular necrosis

You may not qualify if:

  • protrusio acetabuli
  • concentric femoral head migration;
  • presence of extensive surgery of the reference joint (osteotomies around the hip, open or arthroscopic osteochondroplasty for femoral-acetabular impingement)
  • presence of excessive deformity (acetabular or femoral head dysplasia; collapse deformity and deformed femoral head sequelae of Perthes);
  • concomitant rheumatic diseases;
  • bone tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

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

Study Record Dates

First Submitted

December 21, 2019

First Posted

December 24, 2019

Study Start

March 1, 2003

Primary Completion

March 1, 2011

Study Completion

March 1, 2012

Last Updated

December 24, 2019

Record last verified: 2019-12

Locations

IT(1)