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Trial registered on ANZCTR


Registration number
ACTRN12620001251910
Ethics application status
Approved
Date submitted
14/08/2020
Date registered
23/11/2020
Date last updated
1/12/2020
Date data sharing statement initially provided
23/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The pain relief and complications in metatarsalgia randomised controlled trial
Scientific title
A randomised controlled trial comparing flat-cut vs wedge-cut variants of the Weil osteotomy for the treatment of propulsive metatarsalgia.
Secondary ID [1] 301999 0
None
Universal Trial Number (UTN)
U1111-1256-7037
Trial acronym
Linked study record
This study is a sub-study of ACTRN12620000331932, incorporating a subset of the patients eligible for inclusion in the patient registry.

Health condition
Health condition(s) or problem(s) studied:
Propulsive metatarsalgia 318558 0
Condition category
Condition code
Musculoskeletal 316571 316571 0 0
Other muscular and skeletal disorders
Surgery 316572 316572 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Weil osteotomy is a distal oblique osteotomy procedure performed to treat lesser metatarsal deformities and alleviate metatarsalgia, by shortening the metatarsal in the transverse plane. While Weil osteotomies are commonly performed, complications include floating toe, joint stiffness, avascular necrosis, transfer of metatarsalgia to subsequent toes, and plantar flexion of the metatarsal. Wedge-cut osteotomy is a modification of the flat-cut Weil procedure, and includes a second incision to remove a slice of bone. The procedure is purported to reduce plantar translation of the metatarsal head, maintain the metatarsophalangeal (MTP) centre of rotation and improve intrinsic muscle function. However, there is limited in-vivo data for the clinical efficacy of this technique.

In the wedge-cut Weil osteotomy group (the “experimental” intervention), participants will receive two parallel distal oblique incisions in the dorsal aspect of the metatarsal head to remove a wedge of bone, in order to reduce plantar translation while shortening the metatarsal. The osteotomy is performed with or without the following adjunct procedures for lesser toe or soft tissue correction:

- Proximal interphalangeal arthrodesis
- First MTP joint fusion/arthrodesis
- Hallux valgus correction

Weil osteotomy surgery for both the intervention and control groups will typically take less than an hour, and will be performed by a fellowship trained orthopaedic surgeon who specialises in foot, ankle and trauma surgery. Adherence to the protocol will be assessed by comparing the patient osteotomy group allocation as identified in the operation report, to the trial master sheet with the allocation information.
Intervention code [1] 318298 0
Treatment: Surgery
Comparator / control treatment
In the flat-cut Weil osteotomy group (the “control” intervention), participants will receive a single distal oblique incision in the dorsal aspect of the metatarsal head to shorten the metatarsal, by translating the head by 5-10mm. The osteotomy is performed with or without the following adjunct procedures for toe correction:

- Proximal interphalangeal arthrodesis
- First MTP joint fusion/arthrodesis
- Hallux valgus correction

Weil osteotomy surgery for both the intervention and control groups will typically take less than an hour, and will be performed by a fellowship trained orthopaedic surgeon who specialises in foot, ankle and trauma surgery.
Control group
Active

Outcomes
Primary outcome [1] 324715 0
Patient-reported pain as assessed by the Foot and Ankle Outcome Score (FAOS) - Pain subscale.
Timepoint [1] 324715 0
At 12 months postoperatively
Secondary outcome [1] 385513 0
The incidence of procedure-specific complications (stiffness; floating toe; transfer metatarsalgia; non-union/malunion) at postoperative follow-up.

A floating toe is defined as a toe that is not in contact with the floor under weight-bearing conditions. It will be recorded using a weight-bearing coronal view static photograph and manually rated. Metatarsal osteotomy union will be defined using cortical continuity, with patients failing to show any healing (nonunion) and insufficient cortical continuity (delayed) by the postoperative review, identified in the trial data. A web-based form will be completed by the surgeon to log complications data during postoperative review. The data will be collated within the study database and assessed by the research team.
Timepoint [1] 385513 0
At any presentation timepoint, up to 12 months postoperatively

Eligibility
Key inclusion criteria
Patients presenting to the participating surgeons for treatment of propulsive metatarsalgia that are:
- Over 18 years of age
- Eligible for surgical intervention, having failed a minimum 6 months of conservative interventions
- Registered in the surgeons’ practice registry (ANZCTR Registration: ACTRN12620000331932)
- Have provided written informed consent to participation in the trial
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that:
- Require additional procedures involving the soft tissues of the foot-ankle complex
- Have had recent (<6 months) prior surgery to the affected forefoot
- Are judged by the participating surgeons as incapable to complete patient-reported outcome measures as required for the study, for example due to psychological impairment or insufficient English language capacity. (Patients with insufficient English may still be included if it is determined that a suitable translator is present and capable of relaying information to the patient during recruitment and data collection.)
- Have withdrawn consent for information usage in the practice registry
- Have cancelled their surgery booking with the participating surgeon

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly assigned to receive either a flat-cut Weil osteotomy (control group), or wedge-cut Weil osteotomy (experimental group) procedure using a central computer-based simple randomisation system, with a 1:1 allocation without blocking.

Allocation concealment will be ensured, as the system will not release the randomisation code until the patient has been recruited into the trial, and only release it via electronic communication directly to the treating surgeon. The allocation will be embedded into the system created to generate surgical consult lists, and the research team will be able to view the allocation code, but will not receive the allocation key. A member of the research team will have access to the allocation groups, but will not be directly involved in the analysis of the data. The treatment evaluator will not have access to the allocation, and participants will not be told what group they have been allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation will be computer-generated using a random number generator function (Matlab 2018b, Mathworks Inc, USA) during the preparation of consult lists. The result will be transmitted to the treating surgeon using nondescript terms (e.g. Daisy for control group and Daffodil for intervention) , such that the grouping cannot be inferred from the label. The label key will be revealed to the surgeon via separate electronic communication and stored within the system with restricted access by the research team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size required for the primary outcome was established to provide adequate power to detect half an MCID difference (15.3/2) in the FAOS Pain score between the flat-cut and wedge-cut Weil groups, with an average estimated baseline standard deviation of 20.8. The MCID and baseline SD were derived from a previous study (Sierevelt et al. 2016) and 0.5MCID was determined to be a clinically important effect that would influence future clinical decision-making regarding technique selection. A mixed-effects model (analysis of covariance ANCOVA) was selected as the most appropriate to answer the question posed, with power at 0.9 and a of 0.05, with an allowance for a dropout rate of 10%. The required sample size was determined using GPower (Faul et al. 2007) to be N = 80 patients, with patient age at surgery, sex, body mass index, single/multiple procedures and adjunct procedures included as model covariates.

The sample size required for the secondary outcome was established to provide adequate power to detect a 15% reduction in complication incidence from a baseline of 60% incidence. The reduction in incidence was deemed to be the minimal amount of improvement that would influence future decision-making regarding technique selection in this patient population. A one-sided test within a logistic regression model was selected within GPower, with the R-squared for other predictors in the model (patient age at surgery, sex, body mass index, single/multiple procedures and adjunct procedures) set to 0.1. The required sample size was determined to N = 123 procedures.

The primary outcome of the trial will be postoperative pain at 12 months follow up represented by the pain subscale of the FAOS. A mixed-effects analysis of covariance (ANCOVA) will be used to test for differences between groups with the following factors and covariates included in the model:
- Patient ID (random factors)
- Baseline FAOS pain subscore (covariate)
- Age at surgery (covariate)
- Sex (covariate)
- Multiple procedures
- Adjunct procedures

The overall model fit will be assessed with partial eta-squared and beta coefficients with 95% confidence limits will describe the strength and direction of relationships between factors and the postoperative FAOS - Pain score. Post-hoc comparisons with Dunnett tests (against control) will be used to compare osteotomy groups. Cohen’s d will be used to report effect size of differences between groups. A Cohen’s d exceeding 0.36 will be deemed clinically significant.

The secondary outcome of the trial will be the incidence of procedure-specific complications by the end of the follow up period (12months). A binary logistic regression will be used to assess the effect of intervention allocation on complications incidence in a multivariable model containing confounders described above. Alpha will be set at 0.05 and partial eta-squared used to assess model fit. Odds ratios with 95% confidence limits will describe the strength and direction of relationships between model predictors and the probability of having a complication compared to not having one.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17243 0
St George Private Hospital - Kogarah
Recruitment hospital [2] 17244 0
North Shore Private Hospital - St Leonards
Recruitment hospital [3] 17245 0
Castlecrag Private Hospital - Castlecrag
Recruitment postcode(s) [1] 30952 0
2217 - Kogarah
Recruitment postcode(s) [2] 30953 0
2065 - St Leonards
Recruitment postcode(s) [3] 30954 0
2068 - Castlecrag

Funding & Sponsors
Funding source category [1] 306419 0
Self funded/Unfunded
Name [1] 306419 0
Dr Andrew Wines
Address [1] 306419 0
The Mater Clinic
Suite 2, 25 Rocklands Road Wollstonecraft NSW 2065
Country [1] 306419 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Wines
Address
The Mater Clinic
Suite 2, 25 Rocklands Road Wollstonecraft NSW 2065
Country
Australia
Secondary sponsor category [1] 306930 0
Individual
Name [1] 306930 0
Dr Michael Symes
Address [1] 306930 0
St George Private Hospital Specialist Consulting Suites
Suite 201, 131 Princess Highway, Kogarah, NSW, 2217
Country [1] 306930 0
Australia
Other collaborator category [1] 281423 0
Individual
Name [1] 281423 0
Dr Corey Scholes
Address [1] 281423 0
EBM Analytics
119 Willoughby Road, Crows Nest NSW 2065
Country [1] 281423 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306616 0
Ramsay Health Care NSW/VIC Human Research Ethics Committee
Ethics committee address [1] 306616 0
2 Frederick St, St Leonards NSW 2065
Ethics committee country [1] 306616 0
Australia
Date submitted for ethics approval [1] 306616 0
21/07/2020
Approval date [1] 306616 0
19/11/2020
Ethics approval number [1] 306616 0
2020-007

Summary
Brief summary
Propulsive metatarsalgia involves pain under the metatarsal heads during the “third rocker” phase of the gait cycle. Weil osteotomy is used to surgically treat metatarsalgia, by shortening the metatarsal via a distal oblique cut. Adjunct procedures are performed for lesser toe correction when required. While Weil osteotomies are commonly performed, complications include floating toe, joint stiffness and recurrence or transfer of metatarsalgia. “Wedge” osteotomy is a modification of Weil, involving a second incision to remove a slice of bone. The procedure purportedly reduces plantar translation of the metatarsal head, maintains metatarsophalangeal centre of rotation and improves intrinsic muscle function. However, in-vivo data for the clinical efficacy of this technique is limited.

This study aims to investigate whether a wedge-cut Weil osteotomy compared to the traditional flat-cut technique is associated with increased pain relief and fewer complications up to 12 months postoperatively in patients presenting with propulsive metatarsalgia.

Patients will be recruited into an existing patient registry (ACTRN12620000331932) and will be randomised into the flat-cut or wedge-cut (control) Weil osteotomy groups prior to surgery. They will subsequently undergo standard of care consultation for diagnosis and treatment, including the collection of demographic data, patient medical history, radiological findings and pathology. Data collection will be completed routinely at the consulting rooms for the principal investigators.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104478 0
Dr Andrew Wines
Address 104478 0
North Sydney Orthopaedic and Sports Medicine Centre

Suite 2, Mater Clinic
25 Rocklands Road, Wollstonecraft NSW 2065
Country 104478 0
Australia
Phone 104478 0
+61294090563
Fax 104478 0
Email 104478 0
apw1307@bigpond.com
Contact person for public queries
Name 104479 0
Dr Michael Symes
Address 104479 0
Sydney Orthopaedic Trauma & Reconstructive Surgery

Suite 201
131 Princess Highway, Kogarah NSW 2217
Country 104479 0
Australia
Phone 104479 0
+61295874720
Fax 104479 0
Email 104479 0
drmichaelsymes@gmail.com
Contact person for scientific queries
Name 104480 0
Dr Corey Scholes
Address 104480 0
EBM Analytics
119 Willoughby Road, Crows Nest, NSW, 2065
Country 104480 0
Australia
Phone 104480 0
+61299563800
Fax 104480 0
Email 104480 0
cscholes@ebma.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
A completely de-identified data set to an appropriate data archive for sharing purposes. This may coincide with the submission of a manuscript to a peer-reviewed journal for broader dissemination of the trial findings, or it may be submitted as a standalone work.
When will data be available (start and end dates)?
Data will be available no later than 1 year after the collection of the 1-year post randomisation follow up; no end date determined.
Available to whom?
Peers where the interest is academic and not for commercial uses, under appropriate licensing arrangements of de-identified data.
Available for what types of analyses?
Potential uses of the datasets generated during the current study may include subsequent analysis of subgroups for investigation of surgical/management and patient centred outcomes for internal clinic purposes. Any future studies requesting use of this data within allied health networks or collaborations with other research groups will seek appropriate amendment of the relevant ethical approval.
How or where can data be obtained?
Corresponding author details will be supplied on peer-reviewed manuscripts, abstracts and presentations. The corresponding author (Principal Investigator) can be contacted directly via email to request data, subject to approval (where the interest is academic and not for commercial uses):

Dr Andrew Wines
apw1307@bigpond.com
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 8770 0
Study protocol
Citation [1] 8770 0
Link [1] 8770 0
Email [1] 8770 0
Other [1] 8770 0
Link to protocol manuscript will be made available, once published.
Attachment [1] 8770 0
Type [2] 8771 0
Ethical approval
Citation [2] 8771 0
Link [2] 8771 0
Email [2] 8771 0
Other [2] 8771 0
Ethical approval number will be made available, once approved.
Attachment [2] 8771 0
Summary results
No Results