Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001342505p
Ethics application status
Not yet submitted
Date submitted
19/11/2015
Date registered
9/12/2015
Date last updated
9/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient-orientated outcomes following 1st metatarsophalangeal (MTP) joint surgery for hallux rigidus (stiff big toe)
Scientific title
Patient-oriented outcomes following 1st MTP joint arthrodesis for hallux rigidus
Secondary ID [1] 287915 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hallux rigidus surgical outcomes 296798 0
Condition category
Condition code
Surgery 297027 297027 0 0
Other surgery
Musculoskeletal 297081 297081 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients outcomes following 1st metatarsophalangeal (MTP) joint arthrodesis for hallux rigidus will be measured using a self-reported questionnaire of patient concerns using open ended questions, and the American Orthopaedic Foot and Ankle (AOFAS) Hallux Metatarsophalangeal-Interphalangeal (MTP-IP) scale. Participants will be assessed at two weeks, 6 weeks and three months following surgery.
Intervention code [1] 293364 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296629 0
The primary outcome of this study is to assess patient satisfaction with surgery. Patients will be free to respond to questionnaires without the restriction of closed-ended questions. The questionnaire was designed specifically for the study.
Timepoint [1] 296629 0
Patients participating in the study will be questioned two weeks post surgery, 6 weeks post surgery and 3 months after surgery.
Secondary outcome [1] 318957 0
Postoperative complications including symptomatic hardware removal, metatarsalgia or clawing, non union and interphalangeal joint pain can also be established as a result of the post operative questionnaire. The questionnaire was specifically developed for this study to enable patient to provide open answered responses.
Timepoint [1] 318957 0
two weeks post surgery, 6 weeks post surgery and 3 months post surgery.

Eligibility
Key inclusion criteria
Diagnosed with hallux rigidus of grade 1 or greater following plain film X-ray, identified as having undergone an isolated 1st MTP joint arthrodesis in the senior author's private foot and ankle practice within the previous two weeks, no other symptomatic condition of the foot or ankle, discharged from care following successful healing from surgery, consent to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with peripheral neuropathy, diabetes mellitus, inflammatory arthritis, neuromuscular disease, concomitant arthritis located elsewhere in the foot and those who had previously undergone arthrodesis surgery on the same joint

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Changes in mean AOFAS scores before and after surgery will be analysed using paired t-test on GraphPad software. The level of significance will be set at p<0.05. Since no other study of this kind has been performed we can not calculate the appropriate sample size for this study. Based on out bio-statistician's recommendations we estimate that 100 patients will be sufficient to appropriately power our statistical analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2016
Actual
Date of last participant enrolment
Anticipated
29/11/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4683 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 12262 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 292409 0
Charities/Societies/Foundations
Name [1] 292409 0
Norman Beischer Medical Research Foundation
Country [1] 292409 0
Australia
Primary sponsor type
Individual
Name
Mr Andrew Beischer
Address
Victorian Orthopaedic Foot and Ankle Clinic
The Epworth Centre
Level 6, Suite 6.3
32 Erin Street
Richmond
Victoria 3121
Country
Australia
Secondary sponsor category [1] 291097 0
Commercial sector/Industry
Name [1] 291097 0
Melbourne Orthotics
Address [1] 291097 0
44 highbury Road
Burwood
Victoria 3125
Country [1] 291097 0
Australia
Other collaborator category [1] 278707 0
Individual
Name [1] 278707 0
Dr Aileen Ibuki
Address [1] 278707 0
Melbourne Orthotics
44 Highbury Road
Burwood
Victoria, 3125
Country [1] 278707 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293876 0
Epworth Richmond
Ethics committee address [1] 293876 0
89 Bridge Road
Richmond
Vic 3121
Ethics committee country [1] 293876 0
Australia
Date submitted for ethics approval [1] 293876 0
03/02/2016
Approval date [1] 293876 0
Ethics approval number [1] 293876 0

Summary
Brief summary
Hallux Rigidus is the most common arthritic condition of the foot, causing pain and stiffness of the 1st metatarsophalangeal (MTP) joint. Consideration of surgical management following failure of nonoperative treatment is based on multiple factors including age and activity level of the patient, as well as the severity of the arthritis. An arthrodesis of this joint is regarded as the gold standard for treatment of end stage hallux rigidus. The goal of this procedure is to relieve pain and improve functional status. Our study aims to collect information regarding the outcomes of surgery from a patients perspective. This information will allow surgeons to ensure that patients are fully informed of the implications of surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61562 0
Mr Andrew Beischer
Address 61562 0
VOFAC
The Epworth Centre
Level 6, Suite 6.3
32 Erin Street
Richmond
Vic 3121
Country 61562 0
Australia
Phone 61562 0
+61 3 9428 9944
Fax 61562 0
+61 3 9428 9944
Email 61562 0
kate@footsurgeon.com.au
Contact person for public queries
Name 61563 0
Mrs Kate Claxton
Address 61563 0
VOFAC
The Epworth Centre
Level 6, Suite 6.3
32 Erin Street
Richmond
Vic 3121
Country 61563 0
Australia
Phone 61563 0
+61 3 9428 9944
Fax 61563 0
+61 3 9428 3444
Email 61563 0
kate@footsurgeon.com.au
Contact person for scientific queries
Name 61564 0
Mrs Kate Claxton
Address 61564 0
VOFAC
The Epworth Centre
Level 6, Suite 6.3
32 Erin Street
Richmond
Vic 3121
Country 61564 0
Australia
Phone 61564 0
+61 3 9428 9944
Fax 61564 0
+61 3 9428 3444
Email 61564 0
kate@footsurgeon.com.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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