Hammer ToeNCT04610437
Intramedullary Resorbable Fixation System Versus K-wire for the Treatment of Lesser Toe Deformities
A study testing Arthrodesis interphalangeal with intramedullary resorbable fixation system in people with Hammer Toe and Surgery, run by University of Seville at 1 site in Spain.
Trial summary
Hammertoe deformity is one of the most common deformities in the foot and is characterized by dorsiflexion of the proximal phalanx at the metatarsal-phalangeal joint and a plantarflexion of the middle phalanx at the proximal interphalangeal joint. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hammer Toe, Surgery, Deformity of Toe
- What is being tested?
- Arthrodesis interphalangeal with intramedullary resorbable fixation system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2019to 30 Sep 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiological evidence of rigid hammer toe.
- Non-smoking patient.
- Have no previous surgical episode or known trauma to the foot or ankle of the same limb.
- Not have any significant medical comorbidity:
- Uncontrolled hypertension.
- Previous myocardial infarction.
Show all 19Show fewer
- Neoplasms.
- Chronic obstructive pulmonary disease.
- Arrhythmias.
- Morbid obesity.
- Uncontrolled diabetes mellitus.
- Peripheral vascular disease.
- Peripheral neuropathy.
- Lumbar disc herniation.
- Any neuro-muscular alteration.
- That the patient present:
- Palpable peripheral pulses through the posterior tibial artery and pedia.
- Ankle-brachial index or YAO between 1-1.2.
- Partial oxygen saturation> or = 95%.
Who cannot join
- That the patient has undergone another previous surgical procedure on the same foot.
- Known trauma to the foot to be intervened.
- History of sensitivity to local anesthetics.
- Pregnant or lactating women.
- Follow-up time less than 90 days.
- Patients with any systemic pathology or in chronic treatment that could interfere with the favorable evolution of the process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fixation of Digital Arthrodesis With Percutaneous Kirschner Wire Versus Intramedullary Fixation With Resorbable Polylactic Acid Needle: A Comparative Study
Hammertoe deformity is one of the most common deformities in the foot and is characterized by dorsiflexion of the proximal phalanx at the metatarsal-phalangeal joint and a plantarflexion of the middle phalanx at the proximal interphalangeal joint. Surgical intervention for this type of deformity is indicated when the symptoms progress and conservative treatments are not enough, that is, when we are faced with a rigid painful deformity.Arthrodesis of the proximal interphalangeal joint temporarily fixed with a Kirschner wire is the most commonly used techniques.
Therefore, intramedullary fixation with a PLLA needle may be a good alternative. The use of biomaterial is gaining relevance in foot surgery, with polylactic acid being the most widely used due to its strength. Its total biodegradation requires a time of 16-24 months. No cases of foreign body reaction have been described with this type of osteosynthesis material, due to its characteristics similar to those of bone. Its only drawbacks are that it increases the complexity of the technique and that it increases the cost of the procedure. Being a flexible needle, it allows to leave a functional intraoperative claw. It maintains the functionality of the distal interphalangeal joint and carries a lower risk of infection by carrying osteosynthesis material on the outside.
The purpose of the present study is to prospectively collect clinical and radiographic outcomes of operative correction of hammertoe deformity using a fixation system of intramedullary device of polylactic acid versus a kirschner wire.
Read the detailed description
A comparative, prospective, randomised study.
- Conditions
- Hammer Toe, Surgery, Deformity of Toe, Phalanx; Dislocation Toe(S)
- Being tested
- Arthrodesis interphalangeal with intramedullary resorbable fixation system
- Keywords
- arthodesis, kirschner wire, PLLA
- Medical subject headings
- Hammer Toe Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrodesis interphalangeal with intramedullary resorbable fixation systemProcedure or surgery
Also called Arthrodesis interphalangeal with kirschner wire fixation system
Interphalangeal arthrodesis of lesser toes with two different fixation systems.
| Study group | Role | What they receive |
|---|---|---|
| intramedullary reabsorbable fixation system PLLA. | Active comparator | Arthrodesis interphalangeal with intramedullary reabsorbable fixation system PLLA. Receives: Procedure: Arthrodesis interphalangeal with intramedullary resorbable fixation system |
| K-wire | Placebo comparator | Arthrodesis interphalangeal with kirschner wire Receives: Procedure: Arthrodesis interphalangeal with intramedullary resorbable fixation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of AOFAS MTP-IP for the lesser toes
Each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points.
Measured: baseline, 6 weeks, 6 months
Secondary outcomes (4)
Change of Finger alignment.
X-ray in dorsal-plantar projection in load to measure the angle formed between the longitudinal axes of the proximal and middle phalanges. Good: 0-10º. (tb smartoe vs kw buried and the other from smartoe); Enough: 11-20º; or Bad:> 20º.
Measured: Baseline, 6 weeks, 6 months
Change of visual analog scale
Heel pain intensity was referred to as 0-10, in which 0= no pain at all and 10= the worst pain possible
Measured: Baseline, 6 weeks, 6 months
Level of Satisfaction
Satisfaction assessed by the scale.This is a self-administered scale of satisfaction with the procedure with 4 categories. The response categories consisting of very satisfied (4 points), somewhat satisfied (3 points), somewhat dissatisfied ( 2 points), and very dissatisfied (1 points).
Measured: Baseline, 6 weeks, 6 months
Change of Foot health status questionnaire
Foot Health Status Questionnaire: The questionnaire to measure foot health related quality of life. The Foot Health Status Questionnaire Data Analysis Software obtain the scale scores for the domains of; Foot Pain, Foot Function, Footwear, General Foot Health Perceptions from respondent's answers on the questionnaire.The questionnaire does not providean overall score. To obtain these indexes, the responsesare analysed through computer software (FHSQ, version1.03). After processing the data, the software produces ascore ranging from 0 to 100. The maximum score is in-dicative of a person with excellent foot health, no painor discomfort and no difficulty or limitations in puttingon shoes, performing activities of daily life or work, with adequate functional capacity; a score of zero representsthe worst state of health for the foot.
Measured: Baseline, 6 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 May 2019
- Primary completion23 May 2019
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hammer ToeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Coheña-Jiménez, University of Seville
- Investigators
- Pedro Montaño Jiménez, PhD, Study director, University of SevilleLuis María Gordillo Fernández, PhD, Study director, University of SevilleJuan Manuel Muriel Sánchez, Principal investigator, University of SevilleManuel Coheña Jiménez, PhD, Study director, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610437
- Sponsor's protocol ID
- University of Seville-USeville
- Status last verified
- Nov 2020
- First submitted
- 22 Oct 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation of Digital Arthrodesis With Percutaneous Kirschner Wire Versus Intramedullary Fixation With Resorbable Polylactic Acid Needle: A Comparative Study
- ClinicalTrials.gov ID
- NCT04610437
- Acronym / sponsor ID
- University of Seville-USeville
- Conditions
- Hammer Toe, Surgery, Deformity of Toe, Phalanx; Dislocation Toe(S)
- Keywords
- arthodesis, kirschner wire, PLLA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 30 Oct 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.
Hammertoe deformity is one of the most common deformities in the foot and is characterized by dorsiflexion of the proximal phalanx at the metatarsal-phalangeal joint and a plantarflexion of the middle phalanx at the proximal interphalangeal joint. Surgical intervention for this type of deformity is indicated when the symptoms progress and conservative treatments are not enough, that is, when we are faced with a rigid painful deformity.Arthrodesis of the proximal interphalangeal joint temporarily fixed with a Kirschner wire is the most commonly used techniques.
Therefore, intramedullary fixation with a PLLA needle may be a good alternative. The use of biomaterial is gaining relevance in foot surgery, with polylactic acid being the most widely used due to its strength. Its total biodegradation requires a time of 16-24 months. No cases of foreign body reaction have been described with this type of osteosynthesis material, due to its characteristics similar to those of bone. Its only drawbacks are that it increases the complexity of the technique and that it increases the cost of the procedure. Being a flexible needle, it allows to leave a functional intraoperative claw. It maintains the functionality of the distal interphalangeal joint and carries a lower risk of infection by carrying osteosynthesis material on the outside.
The purpose of the present study is to prospectively collect clinical and radiographic outcomes of operative correction of hammertoe deformity using a fixation system of intramedullary device of polylactic acid versus a kirschner wire.
Detailed description
A comparative, prospective, randomised study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intramedullary reabsorbable fixation system PLLA. | Active comparator | Procedure: Arthrodesis interphalangeal with intramedullary resorbable fixation systemArthrodesis interphalangeal with intramedullary reabsorbable fixation system PLLA. |
| K-wire | Placebo comparator | Procedure: Arthrodesis interphalangeal with intramedullary resorbable fixation systemArthrodesis interphalangeal with kirschner wire |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Clinical and radiological evidence of rigid hammer toe.
- Non-smoking patient.
- Have no previous surgical episode or known trauma to the foot or ankle of the same limb.
- Not have any significant medical comorbidity:
- Uncontrolled hypertension.
Key exclusion criteria (6 listed)
- That the patient has undergone another previous surgical procedure on the same foot.
- Known trauma to the foot to be intervened.
- History of sensitivity to local anesthetics.
- Pregnant or lactating women.
- Follow-up time less than 90 days.
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 |
|---|---|---|
| Arthrodesis interphalangeal with intramedullary resorbable fixation systemAlso: Arthrodesis interphalangeal with kirschner wire fixation systemInterphalangeal arthrodesis of lesser toes with two different fixation systems. | Procedure or surgery | K-wire, intramedullary reabsorbable fixation system PLLA. |
Primary outcome
Change of AOFAS MTP-IP for the lesser toes
Time frame: baseline, 6 weeks, 6 months
Each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points.
4 secondary outcomes
Change of Finger alignment.
Time frame: Baseline, 6 weeks, 6 months
Change of visual analog scale
Time frame: Baseline, 6 weeks, 6 months
Level of Satisfaction
Time frame: Baseline, 6 weeks, 6 months
Change of Foot health status questionnaire
Time frame: Baseline, 6 weeks, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Hammer Toe
Not yet recruitingPhase 3
Study to Assess the Long-term Safety of KN3835 in the Treatment and Retreatment of Flexible/Semi-Flexible Hammertoe (HMT)
Flexible Hammertoe, Semi-flexible Hammertoe
RecruitingPhase 3
Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT)
Flexible Hammertoe, Semi-flexible Hammertoe
Recruiting
Treatment Effects on Gait in Hammertoe Patients
Hammertoe
Not yet recruiting
Mg Alloy DrillPins in Hammertoe Deformity Correction
Hammertoe, Hammer Toe Syndrome
Recruiting
Flexor Tenotomy and Ulcer Recurrence
Hammer Toe Syndrome, Foot Ulcer, Diabetic
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.
Pedro Montaño Jiménez, PhD study director
University of Seville
Luis María Gordillo Fernández, PhD study director
University of Seville
Juan Manuel Muriel Sánchez principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrodesis interphalangeal with intramedullary resorbable fixation system in people with Hammer Toe and Surgery, run by University of Seville at 1 site in Spain.
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 19 inclusion and 6 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: finished, as of the sponsor's last update on 17 Nov 2020. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of AOFAS MTP-IP for the lesser toes (time frame: baseline, 6 weeks, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2020.