The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
Primary Purpose
Hallux Valgus, Hallux Rigidus
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
weightbearing
Sponsored by
About this trial
This is an interventional basic science trial for Hallux Valgus focused on measuring MTP Hallux rigidus Osteoarthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Weightbearing
Non weightbearing
Arm Description
Immediate weightbearing after surgery
nonweightbearing x 6 weeks post surgery
Outcomes
Primary Outcome Measures
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
Visual analogue scale(VAS)
patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain
Visual analogue scale(VAS)
patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain
Secondary Outcome Measures
Radiographic healing
Union is defined as new bone formation across the cortex of the fusion site
Full Information
NCT ID
NCT04473196
First Posted
July 7, 2020
Last Updated
July 14, 2020
Sponsor
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT04473196
Brief Title
The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
Official Title
Prospective, Randomized Trial to Evaluate the Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2020 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus, Hallux Rigidus
Keywords
MTP Hallux rigidus Osteoarthritis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Weightbearing
Arm Type
Active Comparator
Arm Description
Immediate weightbearing after surgery
Arm Title
Non weightbearing
Arm Type
Active Comparator
Arm Description
nonweightbearing x 6 weeks post surgery
Intervention Type
Other
Intervention Name(s)
weightbearing
Other Intervention Name(s)
nonweightbearing
Intervention Description
immediate weightbearing
Primary Outcome Measure Information:
Title
Foot and Ankle Ability Measure (FAAM)
Description
Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
Time Frame
pre op
Title
Foot and Ankle Ability Measure (FAAM)
Description
Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
Time Frame
6 months
Title
Visual analogue scale(VAS)
Description
patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain
Time Frame
pre op
Title
Visual analogue scale(VAS)
Description
patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Radiographic healing
Description
Union is defined as new bone formation across the cortex of the fusion site
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Francis, RN
Phone
9022250199
Email
francisp@nshealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Glazebrook, MD FRCS
Organizational Affiliation
NSHA\ Dalhousie UNiversity
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26320560
Citation
Rammelt S, Panzner I, Mittlmeier T. Metatarsophalangeal Joint Fusion: Why and How? Foot Ankle Clin. 2015 Sep;20(3):465-77. doi: 10.1016/j.fcl.2015.04.008. Epub 2015 Jun 10.
Results Reference
background
PubMed Identifier
24878413
Citation
Wood EV, Walker CR, Hennessy MS. First metatarsophalangeal arthrodesis for hallux valgus. Foot Ankle Clin. 2014 Jun;19(2):245-58. doi: 10.1016/j.fcl.2014.02.006. Epub 2014 Mar 21.
Results Reference
background
PubMed Identifier
24685193
Citation
Little JB. First metatarsophalangeal joint arthrodesis in the treatment of hallux valgus. Clin Podiatr Med Surg. 2014 Apr;31(2):281-9. doi: 10.1016/j.cpm.2013.12.009. Epub 2014 Feb 26.
Results Reference
background
Learn more about this trial
The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
We'll reach out to this number within 24 hrs