Acquired Deformities of ToePhase 4NCT01927952
A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes
A Phase 4 study testing Kirschner wire, Integra IPP-On PIP Fusion System and Stryker Smart-Toe Implant in people with Acquired Deformities of Toe, run by Susan Hassenbein at 1 site in United States.
Trial summary
The purpose of this research project is to compare three different methods for fixation of hammertoe deformities: (1) Kirschner wire; (2) Integra IPP-ON PIP Fusion System; and (3) Stryker Smart-Toe implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Deformities of Toe
- What is being tested?
- Kirschner wire, Integra IPP-On PIP Fusion System and Stryker Smart-Toe Implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2016
- Phase
- Phase 4
- 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
- Adult subjects (greater than or equal to 18 years of age) diagnosed with hammertoe deformity, acquired (ICD9 734.5) requiring surgical fixation
- Subject has given voluntary, written informed consent to participate in this clinical investigation.
- Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits
- Subject must be comfortable with speaking, reading, and understanding questions and providing responses in an available translated language.
Who cannot join
- Subjects less than 18 years of age
- Subjects with peripheral or central neurologic disease causing neurologic symptoms, including pain, dysthesia, or numbness of the operative leg
- Subjects diagnosed with complicated diabetes mellitus with noted neuropathy, diagnosed by the 10-g monofilament test
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
The purpose of this research project is to compare three different methods for fixation of hammertoe deformities: (1) Kirschner wire; (2) Integra IPP-ON PIP Fusion System; and (3) Stryker Smart-Toe implant.
Read the detailed description
This is a prospective, randomized study and will assist us in ascertaining which of the three tested interventions has the most beneficial outcome.
- Conditions
- Acquired Deformities of Toe
- Being tested
- Kirschner wire, Integra IPP-On PIP Fusion System, Stryker Smart-Toe Implant
- Keywords
- hammertoe
- 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.
Kirschner wireProcedure or surgery
Surgical fixation utiliziing Kirschner wire
Integra IPP-On PIP Fusion SystemProcedure or surgery
surgical fixation utilizing the Integra IPP-On PIP Fusion System
Stryker Smart-Toe ImplantProcedure or surgery
surgical fixation utilizing the Stryker Smart-Toe Implant
| Study group | Role | What they receive |
|---|---|---|
| Kirschner wire | Active comparator | surgical fixation using a Kirschner wire Receives: Procedure: Kirschner wire |
| Integra IPP-On PIP Fusion System | Active comparator | surgical fixation utilizing the Integra IPP-On PIP Fusion System Receives: Procedure: Integra IPP-On PIP Fusion System |
| Stryker Smart-Toe implant | Active comparator | surgical fixation utilizing the Stryker Smart-Toe implant Receives: Procedure: Stryker Smart-Toe Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Will look at number of participants with complications/adverse events including: floating toe, recurrence of hammertoe, soft tissue infection, medial/lateral mal-alignment at PIP joint, plantar flexion/hyperextension mal-alignment at DIP joint, rotation of toe and need for revision surgery.
Measured: change from baseline to 12 weeks
Secondary outcomes (2)
Functional Outcome
Will look at functional outcomes of patients as reported in the Foot and Ankle Ability Measure (FAAM) questionnaire administered to patients to assess their function pre- and post-surgery.
Measured: change from baseline to 12 weeks
Patient Satisfaction
Will look at overall patient satisfaction with surgical care via a questionnaire administered to patients.
Measured: change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Study withdrawn from IRB approval process by PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acquired Deformities of 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susan Hassenbein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Susan Hassenbein, Milton S. Hershey Medical Center
- Investigators
- Umur Aydogan, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927952
- Sponsor's protocol ID
- IRB - 43245
- Status last verified
- Dec 2013
- First submitted
- 19 Aug 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Coughlin MJ, Dorris J, Polk E. Operative repair of the fixed hammertoe deformity. Foot Ankle Int. 2000 Feb;21(2):94-104. doi: 10.1177/107110070002100202.
PubMed 10694020Reece AT, Stone MH, Young AB. Toe fusion using Kirschner wire. A study of the postoperative infection rate and related problems. J R Coll Surg Edinb. 1987 Jun;32(3):158-9. No abstract available.
PubMed 3656240Zingas C, Katcherian DA, Wu KK. Kirschner wire breakage after surgery of the lesser toes. Foot Ankle Int. 1995 Aug;16(8):504-9. doi: 10.1177/107110079501600809.
PubMed 8520664Klammer G, Baumann G, Moor BK, Farshad M, Espinosa N. Early complications and recurrence rates after Kirschner wire transfixion in lesser toe surgery: a prospective randomized study. Foot Ankle Int. 2012 Feb;33(2):105-12. doi: 10.3113/FAI.2012.0105.
PubMed 22381341Lehman DE, Smith RW. Treatment of symptomatic hammertoe with a proximal interphalangeal joint arthrodesis. Foot Ankle Int. 1995 Sep;16(9):535-41. doi: 10.1177/107110079501600904.
PubMed 8563920Caterini R, Farsetti P, Tarantino U, Potenza V, Ippolito E. Arthrodesis of the toe joints with an intramedullary cannulated screw for correction of hammertoe deformity. Foot Ankle Int. 2004 Apr;25(4):256-61. doi: 10.1177/107110070402500411.
PubMed 15132935Sarrafian SK. Correction of fixed hammertoe deformity with resection of the head of the proximal phalanx and extensor tendon tenodesis. Foot Ankle Int. 1995 Jul;16(7):449-51. doi: 10.1177/107110079501600714.
PubMed 7550962Konkel KF, Sover ER, Menger AG, Halberg JM. Hammer toe correction using an absorbable pin. Foot Ankle Int. 2011 Oct;32(10):973-8. doi: 10.3113/FAI.2011.0973.
PubMed 22224327Gadkari K, et al. A Prospective Comparison of a Permanent Intramedullary Device to K-Wire Fixation for Proximal Interphalangeal Joint Fusion: Early Results. Presented at AAOS Annual Meeting 2013, AOFAS Specialty Day
Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.
PubMed 16309613
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes
- ClinicalTrials.gov ID
- NCT01927952
- Acronym / sponsor ID
- IRB - 43245
- Conditions
- Acquired Deformities of Toe
- Keywords
- hammertoe
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn from IRB approval process by PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Susan HassenbeinUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 23 Aug 2013 (estimated)
- 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.
The purpose of this research project is to compare three different methods for fixation of hammertoe deformities: (1) Kirschner wire; (2) Integra IPP-ON PIP Fusion System; and (3) Stryker Smart-Toe implant.
Detailed description
This is a prospective, randomized study and will assist us in ascertaining which of the three tested interventions has the most beneficial outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kirschner wire | Active comparator | Procedure: Kirschner wiresurgical fixation using a Kirschner wire |
| Integra IPP-On PIP Fusion System | Active comparator | Procedure: Integra IPP-On PIP Fusion Systemsurgical fixation utilizing the Integra IPP-On PIP Fusion System |
| Stryker Smart-Toe implant | Active comparator | Procedure: Stryker Smart-Toe Implantsurgical fixation utilizing the Stryker Smart-Toe implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult subjects (greater than or equal to 18 years of age) diagnosed with hammertoe deformity, acquired (ICD9 734.5) requiring surgical fixation
- Subject has given voluntary, written informed consent to participate in this clinical investigation.
- Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits
- Subject must be comfortable with speaking, reading, and understanding questions and providing responses in an available translated language.
Key exclusion criteria (4 listed)
- Subjects less than 18 years of age
- Subjects with peripheral or central neurologic disease causing neurologic symptoms, including pain, dysthesia, or numbness of the operative leg
- Subjects diagnosed with complicated diabetes mellitus with noted neuropathy, diagnosed by the 10-g monofilament test
- Inability 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 |
|---|---|---|
| Kirschner wireSurgical fixation utiliziing Kirschner wire | Procedure or surgery | Kirschner wire |
| Integra IPP-On PIP Fusion Systemsurgical fixation utilizing the Integra IPP-On PIP Fusion System | Procedure or surgery | Integra IPP-On PIP Fusion System |
| Stryker Smart-Toe Implantsurgical fixation utilizing the Stryker Smart-Toe Implant | Procedure or surgery | Stryker Smart-Toe implant |
Primary outcome
Complications
Time frame: change from baseline to 12 weeks
Will look at number of participants with complications/adverse events including: floating toe, recurrence of hammertoe, soft tissue infection, medial/lateral mal-alignment at PIP joint, plantar flexion/hyperextension mal-alignment at DIP joint, rotation of toe and need for revision surgery.
2 secondary outcomes
Functional Outcome
Time frame: change from baseline to 12 weeks
Patient Satisfaction
Time frame: change from baseline to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Background: PubMed 10694020Coughlin MJ, Dorris J, Polk E. Operative repair of the fixed hammertoe deformity. Foot Ankle Int. 2000 Feb;21(2):94-104. doi: 10.1177/107110070002100202.
- Background: PubMed 3656240Reece AT, Stone MH, Young AB. Toe fusion using Kirschner wire. A study of the postoperative infection rate and related problems. J R Coll Surg Edinb. 1987 Jun;32(3):158-9. No abstract available.
- Background: PubMed 8520664Zingas C, Katcherian DA, Wu KK. Kirschner wire breakage after surgery of the lesser toes. Foot Ankle Int. 1995 Aug;16(8):504-9. doi: 10.1177/107110079501600809.
- Background: PubMed 22381341Klammer G, Baumann G, Moor BK, Farshad M, Espinosa N. Early complications and recurrence rates after Kirschner wire transfixion in lesser toe surgery: a prospective randomized study. Foot Ankle Int. 2012 Feb;33(2):105-12. doi: 10.3113/FAI.2012.0105.
- Background: PubMed 8563920Lehman DE, Smith RW. Treatment of symptomatic hammertoe with a proximal interphalangeal joint arthrodesis. Foot Ankle Int. 1995 Sep;16(9):535-41. doi: 10.1177/107110079501600904.
- Background: PubMed 15132935Caterini R, Farsetti P, Tarantino U, Potenza V, Ippolito E. Arthrodesis of the toe joints with an intramedullary cannulated screw for correction of hammertoe deformity. Foot Ankle Int. 2004 Apr;25(4):256-61. doi: 10.1177/107110070402500411.
- Background: PubMed 7550962Sarrafian SK. Correction of fixed hammertoe deformity with resection of the head of the proximal phalanx and extensor tendon tenodesis. Foot Ankle Int. 1995 Jul;16(7):449-51. doi: 10.1177/107110079501600714.
- Background: PubMed 22224327Konkel KF, Sover ER, Menger AG, Halberg JM. Hammer toe correction using an absorbable pin. Foot Ankle Int. 2011 Oct;32(10):973-8. doi: 10.3113/FAI.2011.0973.
- BackgroundGadkari K, et al. A Prospective Comparison of a Permanent Intramedullary Device to K-Wire Fixation for Proximal Interphalangeal Joint Fusion: Early Results. Presented at AAOS Annual Meeting 2013, AOFAS Specialty Day
- Background: PubMed 16309613Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.
Related trials for Acquired Deformities of Toe
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Medial Malleolus Fracture, Lisfranc Injury
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.
Umur Aydogan, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kirschner wire, Integra IPP-On PIP Fusion System and Stryker Smart-Toe Implant in people with Acquired Deformities of Toe, run by Susan Hassenbein at 1 site in United States.
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 4 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: withdrawn, as of the sponsor's last update on 4 Dec 2013. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Complications (time frame: change from baseline to 12 weeks). 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 NCT01927952, which also lists 10 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 4 Dec 2013.