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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01504438
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 101.1
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Osteoarthritis	Device: Salto-Talaris Total Ankle Replacement; Device: STAR Total Ankle Replacement	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Evaluation Of A Two And Three Piece Total Ankle Replacement
• Actual Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Mar 4, 2020
• Actual Study Completion Date: Mar 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Salto Talaris Total Ankle Replacement	Device: Salto-Talaris Total Ankle Replacement; Salto-Talaris Total ankle replacement surgery
Other: STAR Total Ankle Replacement	Device: STAR Total Ankle Replacement; STAR Total Ankle Replacement

Outcome Measures

Primary Outcome Measures

1. Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain [Baseline, 6 months, 1 year, 2 years, 3 years]

   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

2. Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36). [Baseline, 6 months, 1 year, 2 years, 3 years]

   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

3. Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire. [Baseline, 6 months, 1 year, 2 years, 3 years]

   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.

4. Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System [Baseline, 6 months, 1 year, 2 years, 3 years]

   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.

5. 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. [Baseline, 6 months, 1 year, 2 years, 3 years]

   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.

Secondary Outcome Measures

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]

   In order to understand the effect of the ankle replacement on lower extremity kinematics and kinetics, each subject will be asked to complete a series of functional tasks and level walking trials at each of the study timepoints.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke Medical Plaza Page Road	Durham	North Carolina	United States	27703

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: James A Nunley, MD, Duke University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 15, 2016

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01504438
• Other Study ID Numbers: Pro00031027
• First Posted: Jan 5, 2012
• Last Update Posted: May 5, 2021
• Last Verified: Apr 1, 2021

• Additional relevant MeSH terms: Osteoarthritis

Study Results

Participant Flow

Pre-assignment Detail	Two subjects were not randomized.

Arm/Group Title	Salto-Talaris Total Ankle Replacement	STAR Total Ankle Replacement
Arm/Group Description	Salto-Talaris Total Ankle Replacement surgery	STAR Total Ankle Replacement: STAR Total Ankle Replacement
Period Title: Overall Study
STARTED	48	50
COMPLETED	22	25
NOT COMPLETED	26	25

Baseline Characteristics

Arm/Group Title	Salto-Talaris Total Ankle Replacement	STAR Total Ankle Replacement	Total
Arm/Group Description	Salto-Talaris Total Ankle Replacement surgery	STAR Total Ankle Replacement: STAR Total Ankle Replacement	Total of all reporting groups
Overall Participants	37	37	74
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.83 (11.20)	65.64 (8.17)	65.73 (9.68)
Sex: Female, Male (Count of Participants)
Female	22 59.5%	32 86.5%	54 73%
Male	15 40.5%	5 13.5%	20 27%
Race/Ethnicity, Customized (Count of Participants)
White	33 89.2%	34 91.9%	67 90.5%
Other	4 10.8%	3 8.1%	7 9.5%
Region of Enrollment (Count of Participants)
United States	37 100%	37 100%	74 100%
Smoking status (Count of Participants)
Current	2 5.4%	0 0%	2 2.7%
Former	18 48.6%	15 40.5%	33 44.6%
Never	17 45.9%	20 54.1%	37 50%
Diabetes (Count of Participants)
Yes	3 8.1%	6 16.2%	9 12.2%
No	34 91.9%	29 78.4%	63 85.1%

Outcome Measures

1. Primary Outcome

Title	Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain
Description	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
Time Frame	Baseline, 6 months, 1 year, 2 years, 3 years

Outcome Measure Data

Analysis Population Description

Data not collected at 3 years.

Arm/Group Title	Salto-Talaris Total Ankle Replacement	STAR
Arm/Group Description	Salto-Talaris Total Ankle Replacement surgery	STAR Total Ankle Replacement
Measure Participants	37	37
Baseline	67.0 (25.9)	71.3 (21.4)
6 months	16.7 (22.9)	18.6 (20.0)
1 year	12.0 (19.1)	16.9 (20.8)
2 years	12.4 (19.4)	23.5 (28.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Salto-Talaris Total Ankle Replacement, STAR
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.29
	Comments
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36).
Description	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
Time Frame	Baseline, 6 months, 1 year, 2 years, 3 years

Outcome Measure Data

Analysis Population Description

Data not collected at 3 years.

Arm/Group Title	Salto-Talaris Total Ankle Replacement	STAR Total Ankle Replacement
Arm/Group Description	Salto-Talaris Total Ankle Replacement surgery	STAR Total Ankle Replacement: STAR Total Ankle Replacement
Measure Participants	37	37
Baseline	69.1 (19.3)	67.4 (22.1)
6 months	47.7 (17.4)	51.4 (19.1)
1 year	71.4 (18.7)	70.7 (21.2)
2 years	77.1 (17.3)	69.5 (21.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Salto-Talaris Total Ankle Replacement, STAR
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	ANOVA
	Comments

3. Primary Outcome

Title	Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire.
Description	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.
Time Frame	Baseline, 6 months, 1 year, 2 years, 3 years

Outcome Measure Data

Analysis Population Description

Data not collected at 3 years.

Arm/Group Title	Salto-Talaris Total Ankle Replacement	STAR Total Ankle Replacement
Arm/Group Description	Salto-Talaris Total Ankle Replacement surgery	STAR Total Ankle Replacement: STAR Total Ankle Replacement
Measure Participants	37	37
Baseline	83.0 (19.2)	80.3 (19.5)
6 months	54.9 (14.7)	60.4 (18.7)
1 year	51.5 (12.6)	57.1 (15.6)
2 years	48.5 (12.9)	56.1 (18.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Salto-Talaris Total Ankle Replacement, STAR
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	ANOVA
	Comments

4. Primary Outcome

Title	Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System
Description	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.
Time Frame	Baseline, 6 months, 1 year, 2 years, 3 years

Outcome Measure Data

Analysis Population Description

Data not collected at 3 years.

Arm/Group Title	Salto-Talaris Total Ankle Replacement	STAR Total Ankle Replacement
Arm/Group Description	Salto-Talaris Total Ankle Replacement surgery	STAR Total Ankle Replacement: STAR Total Ankle Replacement
Measure Participants	37	37
Baseline	44.6 (14.9)	46.4 (17.9)
6 months	80.2 (13.5)	76.1 (17.3)
1 year	84.5 (9.9)	78.0 (12.9)
2 years	84.5 (9.3)	64.7 (23.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Salto-Talaris Total Ankle Replacement, STAR
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	ANOVA
	Comments

5. Primary Outcome

Title	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.
Description	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.
Time Frame	Baseline, 6 months, 1 year, 2 years, 3 years

Outcome Measure Data

Analysis Population Description

Data not collected at 3 years.

Arm/Group Title	Salto-Talaris Total Ankle Replacement	STAR Total Ankle Replacement
Arm/Group Description	Salto-Talaris Total Ankle Replacement surgery	STAR Total Ankle Replacement: STAR Total Ankle Replacement
Measure Participants	37	37
Baseline	55.1 (18.9)	51.6 (13.3)
6 months	8.0 (11.3)	51.5 (17.7)
1 year	20.1 (21.5)	26.2 (13.7)
2 years	16.0 (15.1)	18.0 (18.7)

6. Secondary Outcome

Title	Three Dimensional Kinematic and Kinetic Assessment During Level Walking Across Time Following Total Ankle Replacement.
Description	In order to understand the effect of the ankle replacement on lower extremity kinematics and kinetics, each subject will be asked to complete a series of functional tasks and level walking trials at each of the study timepoints.
Time Frame	Baseline, 6 months, 1 year, 2 years, 3 years

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Salto-Talaris Total Ankle Replacement	STAR Total Ankle Replacement
Arm/Group Description	Salto-Talaris Total Ankle Replacement surgery	STAR Total Ankle Replacement: STAR Total Ankle Replacement
Measure Participants	0	0

Adverse Events

Time Frame	Up to 7 years
Arm/Group Title	Salto-Talaris Total Ankle Replacement		STAR Total Ankle Replacement
Arm/Group Description	Salto-Talaris Total Ankle Replacement surgery		STAR Total Ankle Replacement: STAR Total Ankle Replacement
All Cause Mortality
	Salto-Talaris Total Ankle Replacement		STAR Total Ankle Replacement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		1/50 (2%)
Serious Adverse Events
	Salto-Talaris Total Ankle Replacement		STAR Total Ankle Replacement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		1/50 (2%)
General disorders
Death	0/48 (0%)		1/50 (2%)
Other (Not Including Serious) Adverse Events
	Salto-Talaris Total Ankle Replacement		STAR Total Ankle Replacement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.