Comparison Study of Biofoam Porous Metal Versus Allograft to Treat Adult Acquired Flatfoot

This study has been withdrawn prior to enrollment.
(Funding terminated)
Sponsor:
Collaborator:
Wright Medical Technology
Information provided by:
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00949897
First received: July 29, 2009
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to compare the clinical and radiographic outcomes of a randomized, consecutive series of adult patients, with an acquired flatfoot, treated with a lateral column lengthening using an allograft bone wedge versus a titanium porous metal implant (Biofoam, Wright Medical).

Null hypothesis: At six months postoperatively, there is no difference in the degree of correction as measured by the talonavicular coverage angle between patients randomized to allograft and Biofoam.

Alternative hypothesis: At six months postoperatively, the degree of correction as measured by the talonavicular coverage angle will be less in patients randomized to allograft than the degree of correction in patients randomized to Biofoam.


Condition Intervention Phase
Adult Acquired Flatfoot
Device: Biofoam
Other: Iliac Crest Allograft with locked plate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Controlled Trial for Lateral Column Lengthening in Adult Acquired Flatfoot Using Biofoam Porous Metal Compared With Allograft

Resource links provided by NLM:


Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • The degree of correction as measured by talonavicular coverage angle, which is used to quantify the degree of deformity. Degree of correction is defined as the difference between the preoperative and postoperative talonavicular coverage angle. [ Time Frame: 2 weeks, 6 weeks, 12 weeks, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score [ Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Foot Function Index (FFI) Score [ Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Pain Visual Analog Scale (VAS) [ Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Implant failure [ Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Biofoam Device: Biofoam
Device
Other Name: 510(k) Number: K073535
Active Comparator: Iliac Crest Allograft with locked plate Other: Iliac Crest Allograft with locked plate
Other Name: Iliac Crest Allograft

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 25-75
  • Unresponsive to conservative treatment
  • Patient with acquired flatfoot deformity, who is a candidate for lateral column lengthening (Stage IIB) = (greater than > 40% uncoverage of talar head by navicular on standing AP radiograph)

Exclusion Criteria:

  • Less than 25 years of age and greater than 75 years
  • Pre-existing infection
  • Peripheral neuropathy
  • Charcot arthropathy
  • Peripheral vascular disease
  • Rhematoid Arthritis (RA) or inflammatory arthropathy
  • Metal allergy or sensitivity to metal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949897

Locations
United States, North Carolina
OrthoCarolina, P.A.
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Wright Medical Technology
Investigators
Principal Investigator: Robert B Anderson, MD OrthoCarolina, P.A.
  More Information

No publications provided

Responsible Party: Anne J. Schwoebel, Executive Director, OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00949897     History of Changes
Other Study ID Numbers: 120813B
Study First Received: July 29, 2009
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by OrthoCarolina Research Institute, Inc.:
Adult Acquired Flatfoot
Biofoam Porous Metal Implant
Allograft Bone Wedge

Additional relevant MeSH terms:
Flatfoot
Foot Deformities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 26, 2014