Hallux LimitusNCT01048450
Surgical Treatment for Hallux Rigidus
A study testing Joint Resection- Keller Procedure, Joint Fusion and Hemi-metallic Joint Implant in people with Hallux Limitus and Hallux Rigidus, run by American College of Foot and Ankle Surgeons at 6 sites in United States.
Trial summary
The purpose of this study is to examine the long-term outcomes for the surgical treatment of end stage degeneration in the big toe joint. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hallux Limitus, Hallux Rigidus
- What is being tested?
- Joint Resection- Keller Procedure, Joint Fusion and Hemi-metallic Joint Implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2009to Jun 2011
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage hallux limitus/rigidus
- Status post 1 year since having the surgery
- Must have had a joint resection, fusion, or hemi-metallic implant
Who cannot join
- History of seropositive or seronegative arthritis
- Have had a primary surgery before then had one of the above surgeries performed
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Capitol Orthopaedics & SPorts Medicine
Des Moines, Iowa, 50325
Foot & Ankle Center of Northern Colorado
Greeley, Colorado, 80634
Scituate Podiatry Group
Scituate, Massachusetts, 02066
Marc Kravettte
Seattle, Washington, 98101
Michigan Foot & Ankle Center
Southfield, Michigan, 48034
Ankle and Foot Care Centers
Youngstown, Ohio, 44512
About this study
Official title: A Multi-Center Retrospective Review of Resectional Arthroplasty, Arthrodesis and, Hemi-Metallic Joint Implants in the Surgical Treatment of End Stage Hallux Rigidus
The purpose of this study is to examine the long-term outcomes for the surgical treatment of end stage degeneration in the big toe joint.
Read the detailed description
Hallux rigidus is a degenerative process that occurs in the first metatarsophalangeal joint (MTPJ). There are a variety of surgical treatment options available for its treatment including joint sparing and joint destructive procedures. Patients with end stage arthritis are often given several surgical options for the treatment of the first MTPJ. The procedures are correlated to the patient's age, type of shoe gear, activity level, Body Mass Index, degree of arthritis, desire for joint mobility and bone density. This proposal outlines a retrospective study on the long-term efficacy of joint resection, joint fusion, and hemi-metallic first MTPJ implants. A multi-center study of 300 subjects who received surgical repair for end stage arthritis of the first MTPJ will be evaluated. Subjective assessment for pain, function and alignment as well as objective radiographic evaluation will be performed. Further, the frequency and types of adverse events associated with the three surgical techniques will be assessed. The results of this study will provide valuable information to foot and ankle surgeons in making appropriate decisions regarding the treatment options for end stage hallux rigidus.
- Conditions
- Hallux Limitus, Hallux Rigidus
- Being tested
- Joint Resection- Keller Procedure, Joint Fusion, Hemi-metallic Joint Implant
- Keywords
- arthritis, degeneration
- Medical subject headings
- Hallux Limitus, Hallux Rigidus, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint Resection- Keller ProcedureRadiation
Also called Keller Arthoplasty
These subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux
Joint FusionProcedure or surgery
Also called Arthrodesis
Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.
Hemi-metallic Joint ImplantProcedure or surgery
Also called Joint Implant
Those who had a surgical procedure of a hemi-metallic joint implant
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Those who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint) Receives: Radiation: Joint Resection- Keller Procedure; Procedure: Joint Fusion; Procedure: Hemi-metallic Joint Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective: pain, function, alignment
Measured: At least 1 year after surgical intervention
Secondary outcomes (2)
Frequency and types of undesired effects
Measured: At least 1 year after surgical intervention
Demographic data and trends
Measured: At least 1 year after surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJul 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hallux LimitusStudies 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- American College of Foot and Ankle Surgeons
- Sponsor type
- University, hospital or other
- Investigators
- Paul J Kim, DPM, Study director, American College of Foot & Ankle Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048450
- Sponsor's protocol ID
- 0709-1
- Status last verified
- Jan 2010
- First submitted
- 11 Jan 2010
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Gibson JN, Thomson CE. Arthrodesis or total replacement arthroplasty for hallux rigidus: a randomized controlled trial. Foot Ankle Int. 2005 Sep;26(9):680-90. doi: 10.1177/107110070502600904.
PubMed 16174497Raikin SM, Ahmad J. Comparison of arthrodesis and metallic hemiarthroplasty of the hallux metatarsophalangeal joint. Surgical technique. J Bone Joint Surg Am. 2008 Oct;90 Suppl 2 Pt 2:171-80. doi: 10.2106/JBJS.H.00368.
PubMed 18829931
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Retrospective Review of Resectional Arthroplasty, Arthrodesis and, Hemi-Metallic Joint Implants in the Surgical Treatment of End Stage Hallux Rigidus
- ClinicalTrials.gov ID
- NCT01048450
- Acronym / sponsor ID
- 0709-1
- Conditions
- Hallux Limitus, Hallux Rigidus
- Keywords
- arthritis, degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- American College of Foot and Ankle SurgeonsUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Jan 2010 (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 study is to examine the long-term outcomes for the surgical treatment of end stage degeneration in the big toe joint.
Detailed description
Hallux rigidus is a degenerative process that occurs in the first metatarsophalangeal joint (MTPJ). There are a variety of surgical treatment options available for its treatment including joint sparing and joint destructive procedures. Patients with end stage arthritis are often given several surgical options for the treatment of the first MTPJ. The procedures are correlated to the patient's age, type of shoe gear, activity level, Body Mass Index, degree of arthritis, desire for joint mobility and bone density. This proposal outlines a retrospective study on the long-term efficacy of joint resection, joint fusion, and hemi-metallic first MTPJ implants. A multi-center study of 300 subjects who received surgical repair for end stage arthritis of the first MTPJ will be evaluated. Subjective assessment for pain, function and alignment as well as objective radiographic evaluation will be performed. Further, the frequency and types of adverse events associated with the three surgical techniques will be assessed. The results of this study will provide valuable information to foot and ankle surgeons in making appropriate decisions regarding the treatment options for end stage hallux rigidus.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: Joint Resection- Keller Procedure, Procedure: Joint Fusion, Procedure: Hemi-metallic Joint ImplantThose who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- End stage hallux limitus/rigidus
- Status post 1 year since having the surgery
- Must have had a joint resection, fusion, or hemi-metallic implant
Key exclusion criteria (2 listed)
- History of seropositive or seronegative arthritis
- Have had a primary surgery before then had one of the above surgeries performed
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 |
|---|---|---|
| Joint Resection- Keller ProcedureAlso: Keller ArthoplastyThese subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux | Radiation | Treatment |
| Joint FusionAlso: ArthrodesisThose who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint. | Procedure or surgery | Treatment |
| Hemi-metallic Joint ImplantAlso: Joint ImplantThose who had a surgical procedure of a hemi-metallic joint implant | Procedure or surgery | Treatment |
Primary outcome
Subjective: pain, function, alignment
Time frame: At least 1 year after surgical intervention
2 secondary outcomes
Frequency and types of undesired effects
Time frame: At least 1 year after surgical intervention
Demographic data and trends
Time frame: At least 1 year after surgical intervention
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 19 Aug 2011.
- Background: PubMed 16174497Gibson JN, Thomson CE. Arthrodesis or total replacement arthroplasty for hallux rigidus: a randomized controlled trial. Foot Ankle Int. 2005 Sep;26(9):680-90. doi: 10.1177/107110070502600904.
- Background: PubMed 18829931Raikin SM, Ahmad J. Comparison of arthrodesis and metallic hemiarthroplasty of the hallux metatarsophalangeal joint. Surgical technique. J Bone Joint Surg Am. 2008 Oct;90 Suppl 2 Pt 2:171-80. doi: 10.2106/JBJS.H.00368.
- Sponsor's Web siteLink provided by the sponsor.
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Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
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Not yet recruiting
Effect of Foot Core Control Training on Dorsiflexion Function and Gait Biomechanical Characteristics of Patients With Chronic Plantar Fasciitis
Chronic Plantar Fasciitis, Functional Hallux Limitus
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.
Paul J Kim, DPM study director
American College of Foot & Ankle Surgeons
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint Resection- Keller Procedure, Joint Fusion and Hemi-metallic Joint Implant in people with Hallux Limitus and Hallux Rigidus, run by American College of Foot and Ankle Surgeons at 6 sites 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 3 inclusion and 2 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 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
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?
Subjective: pain, function, alignment (time frame: At least 1 year after surgical intervention). 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 NCT01048450, which also lists 2 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 19 Aug 2011.