NCT00988338

Brief Summary

The purpose of this study is to utilize Trinity Evolution as a graft source in foot/ankle fusions and to follow the subjects to measure the clinical outcomes and fusion rate. The hypothesis of the study is that Trinity Evolution will result in fusion rates and clinical outcomes similar to those obtained from autograft and other routinely used allograft materials; these include: fusion, improvement in pain, improvement in function, and absence of adverse events related to the use of the graft source.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

10 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 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

3.3 years

First QC Date

September 29, 2009

Last Update Submit

October 21, 2021

Conditions

Tibiotalar ArthrodesisSubtalar ArthrodesisCalcaneocuboid ArthrodesisTalonavicular ArthrodesisDouble Arthrodesis (i.e. Calcaneocuboid and Talonavicular)Triple Arthrodesis (i.e. Subtalar, Calcaneocuboid, and Talonavicular)

Keywords

Trinity EvolutionArthrodesisFoot FusionAnkle FusionAllograft

Outcome Measures

Primary Outcomes (1)

  • Fusion Success

    12 months

Secondary Outcomes (1)

  • Improvement in scores: Ankle-Hindfoot Scale (AHS), Visual Analog Scale (VAS), and Health Survey (SF-36v2).

    12 months

Study Arms (1)

Trinity Evolution

Biological: Trinity Evolution

Interventions

Trinity EvolutionBIOLOGICAL

Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem and Osteoprogenitor Cells

Also known as: Allograft, Mesenchymal Stem Cells
Trinity Evolution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subject selection will be determined by orthopedic surgeon.

You may qualify if:

  • Foot and/or ankle pathology requiring fusion using open surgical technique with supplemental bone graft/substitute requiring one of the following procedures:
  • Ankle joint fusion
  • Subtalar fusion
  • Calcaneocuboid fusion
  • Talonavicular fusion
  • Double fusions (talonavicular and calcaneocuboid joints)
  • Triple fusions (subtalar, talonavicular, and calcaneocuboid joints)
  • At least 18 years of age
  • Willing and able to comply with the requirements of the protocol including follow-up requirements
  • Willing and able to sign a study-specific informed consent.

You may not qualify if:

  • Use of any other bone graft or bone graft substitute in addition to or in place of Trinity Evolution at the time of surgery
  • Use of adjunctive post-operative stimulation
  • Active local or systemic infection
  • Currently pregnant or considering becoming pregnant during the follow-up period
  • Active malignancy or having been on chemotherapy of any kind for a malignancy in the past 1 year
  • Immunosuppressive therapy of any kind within the past 1 year
  • Has a known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Orthopaedic Associates of South Broward, PA

Hollywood, Florida, 33021, United States

Location

Sinai Hospital of Baltimore / Rubin Institute for Advanced Orthopedics

Baltimore, Maryland, 21215, United States

Location

New Mexico Orthopedics

Albuquerque, New Mexico, 87106, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Ohio Orthopedic Center of Excellence

Upper Arlington, Ohio, 43220, United States

Location

The Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

Central Tennessee Foot and Ankle Center

Sparta, Tennessee, 38583, United States

Location

Franciscan Foot and Ankle Specialists

Burien, Washington, 98166, United States

Location

MeSH Terms

Conditions

Ankylosis

Interventions

Transplantation, Homologous

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Raymond J Linovitz, MD

    Orthofix Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2009

First Posted

October 2, 2009

Study Start

September 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

October 28, 2021

Record last verified: 2021-10

Locations

US(10)