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Surgical Treatment for Hallux Rigidus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01048450
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : August 19, 2011
Information provided by:
American College of Foot and Ankle Surgeons

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.

Condition or disease Intervention/treatment Phase
Hallux Limitus Hallux Rigidus Radiation: Joint Resection- Keller Procedure Procedure: Joint Fusion Procedure: Hemi-metallic Joint Implant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: Treatment
Those who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint)
Radiation: Joint Resection- Keller Procedure
These subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux
Other Name: Keller Arthoplasty

Procedure: Joint Fusion
Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.
Other Name: Arthrodesis

Procedure: Hemi-metallic Joint Implant
Those who had a surgical procedure of a hemi-metallic joint implant
Other Name: Joint Implant

Primary Outcome Measures :
  1. Subjective: pain, function, alignment [ Time Frame: At least 1 year after surgical intervention ]

Secondary Outcome Measures :
  1. Frequency and types of undesired effects [ Time Frame: At least 1 year after surgical intervention ]
  2. Demographic data and trends [ Time Frame: At least 1 year after surgical intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01048450

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United States, Colorado
Foot & Ankle Center of Northern Colorado
Greeley, Colorado, United States, 80634
United States, Iowa
Capitol Orthopaedics & SPorts Medicine
Des Moines, Iowa, United States, 50325
United States, Massachusetts
Scituate Podiatry Group
Scituate, Massachusetts, United States, 02066
United States, Michigan
Michigan Foot & Ankle Center
Southfield, Michigan, United States, 48034
United States, Ohio
Ankle and Foot Care Centers
Youngstown, Ohio, United States, 44512
United States, Washington
Marc Kravettte
Seattle, Washington, United States, 98101
Sponsors and Collaborators
American College of Foot and Ankle Surgeons
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Study Director: Paul J Kim, DPM American College of Foot & Ankle Surgeons
Additional Information:
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Responsible Party: Paul J Kim, DPM, FACFAS, Associate Professor, American College of Foot and Ankle Surgeons Identifier: NCT01048450    
Other Study ID Numbers: 0709-1
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: August 19, 2011
Last Verified: January 2010
Keywords provided by American College of Foot and Ankle Surgeons:
Additional relevant MeSH terms:
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Hallux Rigidus
Hallux Limitus
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Joint Diseases
Foot Injuries
Leg Injuries
Wounds and Injuries