Recruitment

Recruitment Status
Active, not recruiting

Inclusion Criteria

Patients presented with an isolated diagnosis of type II hallux rigidus who are candidates for operative management with dorsal cheilectomy.
The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study
Patients over the age of 18 able to consent to participate
Patients presented with an isolated diagnosis of type II hallux rigidus who are candidates for operative management with dorsal cheilectomy.
The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study
Patients over the age of 18 able to consent to participate

Exclusion Criteria

Patients with systemic inflammtory arthritis
< 18 years of age
Patients that use ambulatory assistive devices
...
Patients with systemic inflammtory arthritis
< 18 years of age
Patients that use ambulatory assistive devices
Patients with significant arthritis requiring alternative surgery other than dorsal cheilectomy
Patient undergoing revision surgery for hallux rigidus to the ipsilateral extremity

Summary

Conditions
Hallux Rigidus
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

Patients presented with an isolated diagnosis of type II hallux rigidus who are candidates for operative management with dorsal cheilectomy.
The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study
Patients over the age of 18 able to consent to participate
Patients presented with an isolated diagnosis of type II hallux rigidus who are candidates for operative management with dorsal cheilectomy.
The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study
Patients over the age of 18 able to consent to participate

Exclusion Criteria

Patients with systemic inflammtory arthritis
< 18 years of age
Patients that use ambulatory assistive devices
...
Patients with systemic inflammtory arthritis
< 18 years of age
Patients that use ambulatory assistive devices
Patients with significant arthritis requiring alternative surgery other than dorsal cheilectomy
Patient undergoing revision surgery for hallux rigidus to the ipsilateral extremity

Locations

Charlotte, North Carolina, 28207
Charlotte, North Carolina, 28207

Tracking Information

NCT #
NCT01825356
Collaborators
Not Provided
Investigators
  • Principal Investigator: John K Ellington, MD OrthoCarolina Research Institute, Inc.
  • John K Ellington, MD OrthoCarolina Research Institute, Inc.