Surgical Treatment for Hallux Rigidus
Primary Purpose
Hallux Limitus, Hallux Rigidus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Joint Resection- Keller Procedure
Joint Fusion
Hemi-metallic Joint Implant
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Limitus focused on measuring arthritis, degeneration
Eligibility Criteria
Inclusion Criteria:
- End stage hallux limitus/rigidus
- Status post 1 year since having the surgery
- Must have had a joint resection, fusion, or hemi-metallic implant
Exclusion Criteria:
- History of seropositive or seronegative arthritis
- Have had a primary surgery before then had one of the above surgeries performed
Sites / Locations
- Foot & Ankle Center of Northern Colorado
- Capitol Orthopaedics & SPorts Medicine
- Scituate Podiatry Group
- Michigan Foot & Ankle Center
- Ankle and Foot Care Centers
- Marc Kravettte
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Those who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint)
Outcomes
Primary Outcome Measures
Subjective: pain, function, alignment
Secondary Outcome Measures
Frequency and types of undesired effects
Demographic data and trends
Full Information
NCT ID
NCT01048450
First Posted
January 11, 2010
Last Updated
August 17, 2011
Sponsor
American College of Foot and Ankle Surgeons
1. Study Identification
Unique Protocol Identification Number
NCT01048450
Brief Title
Surgical Treatment for Hallux Rigidus
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
American College of Foot and Ankle Surgeons
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Limitus, Hallux Rigidus
Keywords
arthritis, degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Those who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint)
Intervention Type
Radiation
Intervention Name(s)
Joint Resection- Keller Procedure
Other Intervention Name(s)
Keller Arthoplasty
Intervention Description
These subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux
Intervention Type
Procedure
Intervention Name(s)
Joint Fusion
Other Intervention Name(s)
Arthrodesis
Intervention Description
Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.
Intervention Type
Procedure
Intervention Name(s)
Hemi-metallic Joint Implant
Other Intervention Name(s)
Joint Implant
Intervention Description
Those who had a surgical procedure of a hemi-metallic joint implant
Primary Outcome Measure Information:
Title
Subjective: pain, function, alignment
Time Frame
At least 1 year after surgical intervention
Secondary Outcome Measure Information:
Title
Frequency and types of undesired effects
Time Frame
At least 1 year after surgical intervention
Title
Demographic data and trends
Time Frame
At least 1 year after surgical intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
End stage hallux limitus/rigidus
Status post 1 year since having the surgery
Must have had a joint resection, fusion, or hemi-metallic implant
Exclusion Criteria:
History of seropositive or seronegative arthritis
Have had a primary surgery before then had one of the above surgeries performed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Kim, DPM
Organizational Affiliation
American College of Foot & Ankle Surgeons
Official's Role
Study Director
Facility Information:
Facility Name
Foot & Ankle Center of Northern Colorado
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80634
Country
United States
Facility Name
Capitol Orthopaedics & SPorts Medicine
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Scituate Podiatry Group
City
Scituate
State/Province
Massachusetts
ZIP/Postal Code
02066
Country
United States
Facility Name
Michigan Foot & Ankle Center
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Ankle and Foot Care Centers
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
Marc Kravettte
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16174497
Citation
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.
Results Reference
background
PubMed Identifier
18829931
Citation
Raikin 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.
Results Reference
background
Links:
URL
http://www.acfas.org
Description
Sponsor's Web site
Learn more about this trial
Surgical Treatment for Hallux Rigidus
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