NCT02096146

Brief Summary

This study will compare TMT Fusion Plate versus two crossed screws for the fixation of first tarsometatarsal joint arthrodesis. Patients who meet eligibility criteria will be randomly assigned to one of these two treatment options.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
3 countries

5 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

March 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

1.8 years

First QC Date

March 21, 2014

Last Update Submit

August 11, 2020

Conditions

Clinical Indication for First Metatarsal Joint Arthrodesis

Keywords

PlateHallux valgusFoot deformityScrewTarsometatarsal angleCost effectiveness

Outcome Measures

Primary Outcomes (1)

  • Change in the patient-reported MOXFQ

    Outcome measures for the study focus on fully validated patient related outcome measures for the foot (MOXFQ).

    Up to 4 weeks pre-operative, Discharge (up to 1 week post-operative), 2 week FU, 6 week FU, 3 month FU, 6 month FU, 12 month FU

Secondary Outcomes (6)

  • Development of bone healing assessed based on x-rays

    6 and 12 weeks postoperative

  • Reconstruction of the joint position based on x-rays

    Pre-operative up to 4 weeks vs. post-operative up to 2 weeks

  • Change in quality of life (EQ-5D)

    Up to 4 weeks pre-operative, discharge (up to 1 week post-op), 2 weeks FU, 6 weeks FU, 3 months FU, 6 months FU, 12 months FU

  • Weekly assessed weight bearing during weeks 6-12

    3 months FU

  • Complications related to implant or surgery

    Starts with surgery and is continued until the end of the study (12 months FU)

  • +1 more secondary outcomes

Study Arms (2)

TMT Fusion Plate

OTHER

Patients are treated with TMT Fusion Plate to encourage bony fusion of the 1st TMT joint.

Procedure: TMT Fusion plate

Two crossed screws

OTHER

Patients are treated with two crossed screws.This procedure is a standard treatment for 1st TMT joint fusion .

Procedure: Two crossed screws

Interventions

TMT Fusion platePROCEDURE

Patients are treated with TMT Fusion Plate a post-market device to encourage bony fusion of the 1st TMT joint.

TMT Fusion Plate
Two crossed screwsPROCEDURE

Patients are treated with two crossed screws.This procedure is a standard treatment for 1st TMT joint fusion.

Two crossed screws

Eligibility Criteria

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

You may qualify if:

  • Age: between 18 and 65 years
  • At least one of the following:
  • st TMT arthritis
  • hallux valgus (intermetatarsal angle (IM) 1-2 angle \> 15° on plain x-ray)
  • st ray hypermobility with or without flat foot
  • Painful condition
  • Ability to understand the content of the patient information / Informed Consent Form
  • Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
  • Signed and dated IRB/EC-approved written informed consent

You may not qualify if:

  • Active infection
  • Previous surgery on the 1st ray of the same foot
  • Previous non-union on the 1st ray of the same foot
  • Clinical obvious arthritis in other joints of the lower extremities
  • Purely seeking plastic surgery
  • Peripheral vascular disease (e.g. advanced diabetes)
  • Peripheral sensory neuropathy (e.g. advanced diabetes)
  • Concurrent surgery of the contralateral foot
  • Any previously medically unmanaged severe systemic disease
  • Substance abuse that would preclude reliable assessment
  • Prisoner
  • Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Mid Michigan Orthopedic Institute - East Lansing

East Lansing, Michigan, 48823, United States

Location

Summit Orthopedics

Woodbury, Minnesota, 55125, United States

Location

NY Downtown Orthopedic Associates

New York, New York, 10038, United States

Location

Centro Médico Imbanaco Cali

Cali, 233, Colombia

Location

Ian Winson

Bristol, BS10 5NB, United Kingdom

Location

MeSH Terms

Conditions

Hallux ValgusFoot Deformities

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • Ian Winson, MB ChB, FRCS

    Southmead Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 26, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 13, 2020

Record last verified: 2020-08

Locations

GB(1)US(3)CO(1)