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Completed

NCT Number: NCT01048450

Surgical Treatment for 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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foot & Ankle Center of Northern Colorado, Greeley, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Joint Resection- Keller Procedure

Radiation

These subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux

Other names: Keller Arthoplasty

Joint Fusion

Procedure

Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.

Other names: Arthrodesis

Hemi-metallic Joint Implant

Procedure

Those who had a surgical procedure of a hemi-metallic joint implant

Other names: Joint Implant

Primary outcomes

  1. Subjective: pain, function, alignment

    Time frame: At least 1 year after surgical intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

American College of Foot and Ankle Surgeons

Other

Registry information

Official study title

A Multi-Center Retrospective Review of Resectional Arthroplasty, Arthrodesis and, Hemi-Metallic Joint Implants in the Surgical Treatment of End Stage Hallux Rigidus

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 13, 2010
Registry last updated
Aug 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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