The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion

July 14, 2020 updated by: Mark Glazebrook, Nova Scotia Health Authority

Prospective, Randomized Trial to Evaluate the Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion

randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this prospective, randomized controlled trial is to determine if there are any adverse outcomes associated with immediate weight bearing as compared to non-weight bearing following first MTP joint fusion. The primary outcome measures will look at patient reported outcomes of pain and function. The secondary outcome measures will be the difference in the incidence of non-union, as well as adverse events/complications (malunion, wound complications, hardware complications, infection, stress fracture).

Study Type

Interventional

Enrollment (Anticipated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or great
  • Medically fit for surgery
  • Patients diagnosed with condition for which a 1st MTP joint fusion is a surgical management option based on clinical examination and radiographs
  • Failed non-operative management (orthotics, bracing, Tylenol, NSAIDs, shoe-wear modification)
  • Surgery is for an isolated 1st MTP fusion
  • Able and willing to comply with follow up schedule and requirements
  • Capable of providing informed consent

Exclusion Criteria:

  • Age <18 years old
  • Surgical booking is for more than just 1st MTP fusion
  • Unable to comply with follow up schedule and requirements
  • Unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Weightbearing
Immediate weightbearing after surgery
Other: weightbearing
immediate weightbearing
Other Names:
  • nonweightbearing
Active Comparator: Non weightbearing
nonweightbearing x 6 weeks post surgery
Other: weightbearing
immediate weightbearing
Other Names:
  • nonweightbearing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot and Ankle Ability Measure (FAAM)
Time Frame: pre op
Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
pre op
Foot and Ankle Ability Measure (FAAM)
Time Frame: 6 months
Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
6 months
Visual analogue scale(VAS)
Time Frame: pre op
patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain
pre op
Visual analogue scale(VAS)
Time Frame: 12 weeks
patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic healing
Time Frame: 6 weeks
Union is defined as new bone formation across the cortex of the fusion site
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Mark Glazebrook, MD FRCS, NSHA\ Dalhousie UNiversity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 30, 2020

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTC 2020-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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