NCT02289976

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 medial 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

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

9 months

First QC Date

November 10, 2014

Last Update Submit

November 12, 2014

Conditions

Avascular Necrosis of Bone

Keywords

talar avascular necrosisosteochondrosis dissecansfemoral condyle

Outcome Measures

Primary Outcomes (1)

  • Pain reduction

    measured by visual anloge scale

    pre operation; 3, 6, 12 months post operation

Secondary Outcomes (3)

  • Revascularization of the talus in the MRI

    6, 12 month post operation

  • Lower Extremity Functional Scale

    pre operation; 3, 6, 12 month post operation

  • American Orthopaedic Foot and Ankle Society (AOFAS-) Ankle-Hindfoot-Score

    pre operation; 3, 6, 12 month post operation

Study Arms (2)

femoral condyle

ACTIVE COMPARATOR

Core decompression of the talar avascular necrosis followed by free microvascular femoral condyle grafting

Procedure: core decompression

core decompression

ACTIVE COMPARATOR

Core decompression and nonvascularized autograft from the iliac crest

Procedure: core decompression

Interventions

core decompressionPROCEDURE

Drilling of the avascular necrosis of the talus by 10mm drill under x-ray control

core decompressionfemoral condyle

Eligibility Criteria

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

You may qualify if:

  • patients with talar avascular necrosis without response to non-surgical treatment (immobilization) and with need for surgical intervention (Ficat and Arlet stage II and III; Berndt and Harty stage II and III)

You may not qualify if:

  • talar avascular necrosis stage I (without need for surgical intervention)
  • surgical revascularization in the past
  • participation in a different study
  • pregnancy
  • peripheral artery occlusive disease
  • drug associated talar avascular necrosis
  • ongoing steroid therapy or chemo therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BG Trauma Center Ludwigshafen

Ludwigshafen am Rhein, Rhineland-Palatinate, 67071, Germany

RECRUITING

Related Publications (4)

  • Ficat RP. Idiopathic bone necrosis of the femoral head. Early diagnosis and treatment. J Bone Joint Surg Br. 1985 Jan;67(1):3-9. doi: 10.1302/0301-620X.67B1.3155745. No abstract available.

    PMID: 3155745BACKGROUND

  • BERNDT AL, HARTY M. Transchondral fractures (osteochondritis dissecans) of the talus. J Bone Joint Surg Am. 1959 Sep;41-A:988-1020. No abstract available.

    PMID: 13849029BACKGROUND

  • Doi K, Sakai K. Vascularized periosteal bone graft from the supracondylar region of the femur. Microsurgery. 1994;15(5):305-15. doi: 10.1002/micr.1920150505.

    PMID: 7934797RESULT

  • Hussl H, Sailer R, Daniaux H, Pechlaner S. Revascularization of a partially necrotic talus with a vascularized bone graft from the iliac crest. Arch Orthop Trauma Surg. 1989;108(1):27-9. doi: 10.1007/BF00934153.

    PMID: 2643938RESULT

MeSH Terms

Conditions

OsteonecrosisOsteochondritis Dissecans

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsOsteochondritis

Study Officials

  • Thomas Kremer, Phd, MD

    BG Trauma Center Ludwigshafen

    STUDY DIRECTOR

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 10, 2014

First Posted

November 13, 2014

Study Start

February 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2016

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

DE(1)