Hallux ValgusNCT04473196
The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
A study testing weightbearing in people with Hallux Valgus and Hallux Rigidus, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus, Hallux Rigidus
- What is being tested?
- weightbearing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2020to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia, B3h1V7
Trish Francis, trish.francis@nshealth.ca
About this study
Official title: 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
Read the 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).
- Conditions
- Hallux Valgus, Hallux Rigidus
- Being tested
- weightbearing
- Keywords
- MTP Hallux rigidus Osteoarthritis
- Medical subject headings
- Hallux Valgus, Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weightbearingOther
Also called nonweightbearing
immediate weightbearing
| Study group | Role | What they receive |
|---|---|---|
| Weightbearing | Active comparator | Immediate weightbearing after surgery Receives: Other: weightbearing |
| Non weightbearing | Active comparator | nonweightbearing x 6 weeks post surgery Receives: Other: weightbearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
Measured: pre op
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
Measured: 6 months
Visual analogue scale(VAS)
patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain
Measured: pre op
Visual analogue scale(VAS)
patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain
Measured: 12 weeks
Secondary outcomes (1)
Radiographic healing
Union is defined as new bone formation across the cortex of the fusion site
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start30 Sep 2020
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Glazebrook, MD FRCS, Principal investigator, NSHA\ Dalhousie UNiversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473196
- Sponsor's protocol ID
- PTC 2020-01
- Status last verified
- Aug 2024
- First submitted
- 7 Jul 2020
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26320560Wood 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.
PubMed 24878413Little 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.
PubMed 24685193Purdie SD, Glazebrook HM, Dissanayake R, Burgesson BN, Morash JG, Glazebrook MA. To Walk or Not? A Prospective, Randomised Controlled Trial to Evaluate the Effect of Weightbearing on Patient Outcomes Following First Metatarsophalangeal Joint Fusion. Foot Ankle Int. 2026 Oct 9:10711007261481828. doi: 10.1177/10711007261481828. Online ahead of print.
PubMed 42852924
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial to Evaluate the Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
- ClinicalTrials.gov ID
- NCT04473196
- Acronym / sponsor ID
- PTC 2020-01
- Conditions
- Hallux Valgus, Hallux Rigidus
- Keywords
- MTP Hallux rigidus Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weightbearing | Active comparator | Other: weightbearingImmediate weightbearing after surgery |
| Non weightbearing | Active comparator | Other: weightbearingnonweightbearing x 6 weeks post surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weightbearingAlso: nonweightbearingimmediate weightbearing | Other | Non weightbearing, Weightbearing |
Primary outcome
Foot and Ankle Ability Measure (FAAM)
Time frame: pre op
Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
Foot and Ankle Ability Measure (FAAM)
Time frame: 6 months
Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
Visual analogue scale(VAS)
Time frame: pre op
patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain
Visual analogue scale(VAS)
Time frame: 12 weeks
patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain
1 secondary outcome
Radiographic healing
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 26320560Rammelt 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.
- Background: PubMed 24878413Wood 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.
- Background: PubMed 24685193Little 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.
- Derived from this study: PubMed 42852924Purdie SD, Glazebrook HM, Dissanayake R, Burgesson BN, Morash JG, Glazebrook MA. To Walk or Not? A Prospective, Randomised Controlled Trial to Evaluate the Effect of Weightbearing on Patient Outcomes Following First Metatarsophalangeal Joint Fusion. Foot Ankle Int. 2026 Oct 9:10711007261481828. doi: 10.1177/10711007261481828. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Hallux Valgus
Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
RecruitingObservational study
A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
Hallux Valgus
Active, not recruiting
The Hyalex MTP Study
Hallux Valgus, Hallux Limitus
Not yet recruitingObservational study
Incidence and Risk Factors of Postoperative Chronic Pain in Patients Who Have Undergone Hallux Valgus Surgery
Postoperative Chronic Pain, Hallux Valgus Surgery
Recruiting
A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery
Hallux Valgus, Orthopedic Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Glazebrook, MD FRCS principal investigator
NSHA\ Dalhousie UNiversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weightbearing in people with Hallux Valgus and Hallux Rigidus, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Francis, RN (9022250199, francisp@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and Ankle Ability Measure (FAAM) (time frame: pre op). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04473196, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.