NCT02291900

Brief Summary

The purpose of this study is to determine if surgical angiogenesis performed in talar avascular necrosis by free microvascular bone grafts from the femoral condyle is a superior technique compared to core decompression and nonvascularized osseous autografts.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

November 12, 2014

Last Update Submit

November 15, 2014

Conditions

Avascular Necrosis of Bone

Keywords

avascular necrosis, talus, medial femoral condyle

Outcome Measures

Primary Outcomes (1)

  • Pain reduction

    3, 6, 12 months post operation

Secondary Outcomes (3)

  • Lower Extremity Functional Scale

    pre operation; 3, 6, 12 month post operation

  • Revascularization (Association International de Recherche sur la Circulation Osseuse-Criteria)

    6 and 12 month postoperative

  • American Orthopaedic Foot and Ankle Society- Ankle and Hindfoot Score

    pre operation; 3, 6, 12 month post operation

Study Arms (2)

medial femoral condyle

ACTIVE COMPARATOR

Patients in this arm receive core decompression followed by free vascularized medial femoral condyle graft

Procedure: core decompression

core decompression

ACTIVE COMPARATOR

Patients in this arm receive core decompression followed by osseous autograft from the iliac crest

Procedure: core decompression

Interventions

core decompressionPROCEDURE

retrograd drilling of the avascular talar necrosis, followed by osseous autograft

core decompressionmedial femoral condyle

Eligibility Criteria

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

You may qualify if:

  • Avascular talar necrosis stage 2 and 3 (Ficat and Arlet)
  • signed patient consent form

You may not qualify if:

  • steroid or chemo therapy
  • participation in a different study
  • pregnancy
  • peripheral artery occlusive disease stage 3 and 4
  • avascular talar necrosis stage 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BG Trauma Center Ludwigshafen

Ludwigshafen am Rhein, Rhineland-Palatinate, 67071, Germany

RECRUITING

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ulrich Kneser, Phd, MD

    BG Trauma Center Ludwigshafen

    STUDY CHAIR

Central Study Contacts

Victoria F Struckmann, MD

CONTACT

0049-17663158299vfs@me.com

Thomas Kremer, PhD, MD

CONTACT

0049-162-68108913thomas.kremer@bgu-ludwigshafen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 17, 2014

Study Start

February 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2016

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

DE(1)