Prospective Randomized Evaluation of a Two and Three Piece Total Ankle Replacement

NCT01504438 | Completed Results

• 1 other identifier: Pro00031027
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized study to prospectively compare and evaluate the functional outcome and patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either the STAR or Salto-Talaris prothesis.

Conditions

Ankle Osteoarthritis

Outcome Measures

Primary Outcomes (5)

• Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain

  To assess changes in pain across time following total ankle replacement. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a mark on a 100mm line that represents a continuum between "no pain" and "worst pain." A score of 0 represents less pain intensity while a score of 100 represents high pain intensity

  Baseline, 6 months, 1 year, 2 years, 3 years

• Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36).

  The SF-36 comprises 36 questions which cover eight domains of health: Limitations in physical activities because of health problems, Limitations in social activities because of physical or emotional problems, Limitations in usual role activities because of physical health problems, Bodily pain, General mental health (psychological distress and well-being), Limitations in usual role activities because of emotional problems, Vitality (energy and fatigue), and General health perceptions. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high Quality of Life (QOL). Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability

  Baseline, 6 months, 1 year, 2 years, 3 years

• Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire.

  The SMFA consists of two sections: 34 questions covering the assessment of the patient's function and 12 questions covering how bothered patients are by their symptoms. Items are scored in six categories: daily activities, emotional status, arm and hand function, mobility category, and bother index. On a scale of 1 to 5, patients rate their ability on each item and higher total scores represent greater degree of dysfunction or bother. SMFA higher total score represent greater degree of dysfunction or bother. The lowest score is 0 representing the best possible function and the highest score is 100 representing an overall higher degree of dysfunction or bother.

  Baseline, 6 months, 1 year, 2 years, 3 years

• Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System

  The AOFAS Ankle-Hindfoot Rating System is a standardized evaluation of the clinical status of the ankle-hindfoot. Patients report their pain and physicians assess alignment; the patient and physician work together to complete the functional portion. Scores range from 0 to 100, with healthy ankles receiving 100 points.

  Baseline, 6 months, 1 year, 2 years, 3 years

• To Measure a Change in One's Daily Activity Following a Total Ankle Replacement Using the Foot and Ankle Disability Index (FADI) at Multiple Time Points.

  The FADI has 26 items, each of which is scored from 0 (unable to do) to 4 (no difficulty at all). The four pain items of the FADI are scored 0 (none) to 4 (unbearable). The total score ranges 0 to 104 with higher scores indicating a better outcome.

  Baseline, 6 months, 1 year, 2 years, 3 years

Secondary Outcomes (1)

• Three Dimensional Kinematic and Kinetic Assessment During Level Walking Across Time Following Total Ankle Replacement.

  Baseline, 6 months, 1 year, 2 years, 3 years

Study Arms (2)

Salto Talaris Total Ankle Replacement

OTHER

Device: Salto-Talaris Total Ankle Replacement

STAR Total Ankle Replacement

OTHER

Device: STAR Total Ankle Replacement

Interventions

Salto-Talaris Total Ankle Replacement DEVICE

Salto-Talaris Total ankle replacement surgery

Salto Talaris Total Ankle Replacement

STAR Total Ankle Replacement DEVICE

STAR Total Ankle Replacement

STAR Total Ankle Replacement

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age \> 18 years) who will benefit from a total ankle replacement, as determined by Drs. Nunley, DeOrio, or Easley, with the aid of the physical exam and routine radiography treated at Duke University Medical Center and who have no medical conditions that would represent contraindications to surgery or anesthesia will be asked to participate in this study.

You may not qualify if:

• The only excluded patients will be those who do not choose to participate in this study, have a weight greater than 250lbs, or do not meet the minimum age of 18 years.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Medical Plaza Page Road

Durham, North Carolina, 27703, United States

Location

Results Point of Contact

• Title: James Nunley II, M.D.
• Organization: Duke University

james.nunley@duke.edu

919-684-4033

Study Officials

• James A Nunley, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: January 5, 2012
• Study Start: October 1, 2011
• Primary Completion: March 4, 2020
• Study Completion: March 4, 2020
• Last Updated: May 5, 2021
• Results First Posted: May 5, 2021

Record last verified: 2021-04

Locations

US (1)