NCT03325504

Brief Summary

ORTHOUNION is a multi-centre, open, comparative, randomized, clinical trial with three parallel arms that aims to compare the efficacy of three treatments to enhance bone healing in patients with long bone non-union.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_3

Geographic Reach
4 countries

19 active sites

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

September 5, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

5.1 years

First QC Date

October 25, 2017

Last Update Submit

December 2, 2024

Conditions

Non Union Fracture

Keywords

Non-unionAdvanced therapiesMesenchymal stem cellsLong bone

Outcome Measures

Primary Outcomes (1)

  • Bone consolidation

    The percentage of bone consolidation in the comparator treatment arm ( iliac crest autograft) and experimental treatment arm (mesenchymal cells).

    12 months after treatment

Secondary Outcomes (5)

  • Bone consolidation

    6 and 24 months

  • Radiological Bone consolidation

    6, 12 and 24 months

  • Level of Pain

    6, 12 and 24 months

  • Complications

    6, 12 and 24 months

  • Health status

    6, 12 and 24 months

Study Arms (3)

hBM-MSCs-Low Dose

EXPERIMENTAL

Autologous Cultured Mesenchymal Stem Cells +Biomaterial (Low Dose): 100x106 cells

Biological: Cultured Mesenchymal Stem Cells

hBM-MSCs-High Dose

EXPERIMENTAL

Autologous Cultured Mesenchymal Stem Cells+Biomaterial (High Dose): 200x106 cells

Biological: Cultured Mesenchymal Stem Cells

Autologous iliac crest graft

ACTIVE COMPARATOR

Autologous Iliac Crest Grafting

Procedure: Autologous iliac crest graft

Interventions

Cultured Mesenchymal Stem CellsBIOLOGICAL

Cultured Mesenchymal Stem Cells obtained from expanded bone marrow

hBM-MSCs-High DosehBM-MSCs-Low Dose
Autologous iliac crest graftPROCEDURE

Autologous iliac crest grafting

Autologous iliac crest graft

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and older, both sexes
  • Traumatic isolated closed or open Gustilo I and II, IIIA and IIIB humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture with a status of atrophic, oligotrophic or normotrophic non-union.
  • Able to understand, accept and sign informed consent
  • Medical health coverage
  • Able to understand and accept the study constraints

You may not qualify if:

  • Hypertrophic non-unions
  • Segmental bone loss requiring specific therapy (bone transport, vascularized graft, large structural allograft, megaprosthesis, etc)
  • Unrecovered vascular or neural injury
  • Other fractures causing interference with weight bearing
  • Visceral injuries or diseases interfering with callus formation (severe cranioencephalic trauma, etc.)
  • Active infection of any location and aetiology
  • Surgical contraindication of any cause
  • Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control.
  • Malignant tumour (past history or concurrent disease)(except carcinoma in situ or basalioma in remission)
  • History of bone harvesting on iliac crest contraindicating new iliac crest bone graft harvesting or bone marrow collection
  • Insulin dependent diabetes
  • Any evidence (confirmed by PCR) of active infection with HIV, Hepatitis B or Hepatitis C infection
  • Any evidence of Syphilis
  • Known allergies to products involved in the production process of MSC
  • Autoimmune inflammatory disease
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Department of Orthopaedic Surgery, Hospital Henri Mondor

Créteil, France

Location

Department of Orthopaedic Surgery, CHU Nantes

Nantes, France

Location

Department of Orthopaedic Surgery Toulouse University Hospital

Toulouse, France

Location

Department of Orthopaedic Surgery, CHU Tours

Tours, 37044, France

Location

Universitätsklinikum Frankfurt, Department of Trauma, Hand and Reconstructive Surgery

Frankfurt, Germany

Location

Universitätsklinikum Freiburg, Klinik für Orthopädie und Unfallchirurgie

Freiburg im Breisgau, Germany

Location

Universitätsklinikum München

Munich, Germany

Location

Department of Orthopaedic Trauma, University of Ulm

Ulm, 8907581, Germany

Location

Istituto Ortopedico Rizzoli, SSD Fisiopatologia Ortopedica e Medicina Rigenerativa

Bologna, 40136, Italy

Location

Arienda Spedali Civili di Brescia II Ortopedia e Traumatologia

Brescia, Italy

Location

Istituto Ortopedico Galeazzi, Chirugia dell´Anca l

Milan, Italy

Location

Hospital U. Puerta de Hierro-Majadahonda, Servicio de Cirugía Ortopédica y Traumatología

Majadahonda, Madrid, Spain

Location

Hospital Clínica San Carlos, Servicio de Cirugía Ortopédica y Traumatología

Madrid, Spain

Location

Hospital U. 12 de Octubre, Servicio de Cirugía Ortopédica y Traumatología

Madrid, Spain

Location

Hospital U. Gregorio Marañon, Servicio de Cirugía Ortopédica y Traumatología

Madrid, Spain

Location

Hospital U. La Princesa, Servicio de CirugíaOrtopédica y Traumatología

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz

Madrid, Spain

Location

Related Publications (1)

  • Gomez-Barrena E, Padilla-Eguiluz NG, Avendano-Sola C, Payares-Herrera C, Velasco-Iglesias A, Torres F, Rosset P, Gebhard F, Baldini N, Rubio-Suarez JC, Garcia-Rey E, Cordero-Ampuero J, Vaquero-Martin J, Chana F, Marco F, Garcia-Coiradas J, Caba-Dessoux P, de la Cuadra P, Hernigou P, Flouzat-Lachaniette CH, Gouin F, Mainard D, Laffosse JM, Kalbitz M, Marzi I, Sudkamp N, Stockle U, Ciapetti G, Donati DM, Zagra L, Pazzaglia U, Zarattini G, Capanna R, Catani F. A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol. Stem Cells Int. 2018 Feb 22;2018:6025918. doi: 10.1155/2018/6025918. eCollection 2018.

    PMID: 29535772BACKGROUND

Related Links

MeSH Terms

Conditions

Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Enrique Gomez-Barrena, Prof

    Universidad Autonoma de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor and Chair of orthopaedic surgery

Study Record Dates

First Submitted

October 25, 2017

First Posted

October 30, 2017

Study Start

September 5, 2017

Primary Completion

October 17, 2022

Study Completion

December 15, 2023

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations

ES(7)DE(4)IT(3)FR(5)