Surgical Treatment for Hallux Rigidus
A Multi-Center Retrospective Review of Resectional Arthroplasty, Arthrodesis and, Hemi-Metallic Joint Implants in the Surgical Treatment of End Stage Hallux Rigidus
1 other identifier
interventional
158
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2009
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 11, 2010
CompletedFirst Posted
Study publicly available on registry
January 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedAugust 19, 2011
January 1, 2010
1.9 years
January 11, 2010
August 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective: pain, function, alignment
At least 1 year after surgical intervention
Secondary Outcomes (2)
Frequency and types of undesired effects
At least 1 year after surgical intervention
Demographic data and trends
At least 1 year after surgical intervention
Study Arms (1)
Treatment
EXPERIMENTALThose who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint)
Interventions
These subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux
Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.
Those who had a surgical procedure of a hemi-metallic joint implant
Eligibility Criteria
You may qualify if:
- End stage hallux limitus/rigidus
- Status post 1 year since having the surgery
- Must have had a joint resection, fusion, or hemi-metallic implant
You may not qualify if:
- History of seropositive or seronegative arthritis
- Have had a primary surgery before then had one of the above surgeries performed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Foot & Ankle Center of Northern Colorado
Greeley, Colorado, 80634, United States
Capitol Orthopaedics & SPorts Medicine
Des Moines, Iowa, 50325, United States
Scituate Podiatry Group
Scituate, Massachusetts, 02066, United States
Michigan Foot & Ankle Center
Southfield, Michigan, 48034, United States
Ankle and Foot Care Centers
Youngstown, Ohio, 44512, United States
Marc Kravettte
Seattle, Washington, 98101, United States
Related Publications (2)
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.
PMID: 16174497BACKGROUNDRaikin 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.
PMID: 18829931BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul J Kim, DPM
American College of Foot & Ankle Surgeons
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 11, 2010
First Posted
January 13, 2010
Study Start
July 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 19, 2011
Record last verified: 2010-01