Trial Outcomes & Findings for Surgical Treatment for Great Toe Arthritis (NCT NCT03935880)
NCT ID: NCT03935880
Last Updated: 2022-10-28
Results Overview
The Foot and Ankle Ability Measure (FAAM-ADL) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The 21-item FAAM-ADL Questionnaire: scored as N/A, unable to do, extreme difficulty, moderate difficulty, slight difficulty, no difficulty, and/or a percentage (scale from 0-100, where higher scores indicate better physical function).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2
Results posted on
2022-10-28
Participant Flow
Between April 2019 and September 2021, 20 participants were enrolled in the study and randomized. Surgical treatments began in July 2021.
Participant milestones
| Measure |
Cartiva Hemiarthroplasty
Cartiva implant: The procedure starts with a small incision over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected, leaving approximately 2 mm of surrounding bone on the metatarsal head. A guide pin is placed within the metatarsal and a drill is then used to create a site for the implant. The implant is then placed using the implant introducer. The incision is then closed and a sterile dressing is placed.
|
Cheilectomy
Bone spur removal
Cheilectomy: A small incision is made over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected. The top of the metatarsal head is then cut with a sagittal saw. Additional bone spurs are resected. The incision is closed and a sterile dressing is placed.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
Completed Surgery
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cartiva Hemiarthroplasty
Cartiva implant: The procedure starts with a small incision over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected, leaving approximately 2 mm of surrounding bone on the metatarsal head. A guide pin is placed within the metatarsal and a drill is then used to create a site for the implant. The implant is then placed using the implant introducer. The incision is then closed and a sterile dressing is placed.
|
Cheilectomy
Bone spur removal
Cheilectomy: A small incision is made over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected. The top of the metatarsal head is then cut with a sagittal saw. Additional bone spurs are resected. The incision is closed and a sterile dressing is placed.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Surgical Treatment for Great Toe Arthritis
Baseline characteristics by cohort
| Measure |
Cartiva Hemiarthroplasty
n=9 Participants
Cartiva implant: The procedure starts with a small incision over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected, leaving approximately 2 mm of surrounding bone on the metatarsal head. A guide pin is placed within the metatarsal and a drill is then used to create a site for the implant. The implant is then placed using the implant introducer. The incision is then closed and a sterile dressing is placed.
|
Cheilectomy
n=10 Participants
Bone spur removal
Cheilectomy: A small incision is made over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected. The top of the metatarsal head is then cut with a sagittal saw. Additional bone spurs are resected. The incision is closed and a sterile dressing is placed.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
n=5 Participants
|
58.4 years
n=7 Participants
|
60.25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Number of Participants Who Smoke
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body Mass Index
|
28.5 kg/m^2
n=5 Participants
|
25.1 kg/m^2
n=7 Participants
|
26.5 kg/m^2
n=5 Participants
|
|
Preoperative first metatarsophalangeal (MTP) peak active dorsiflexion (PAD)
|
30.0 degrees
n=5 Participants
|
30.0 degrees
n=7 Participants
|
30.0 degrees
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2Population: Study was terminated before the final time point per protocol.
The Foot and Ankle Ability Measure (FAAM-ADL) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The 21-item FAAM-ADL Questionnaire: scored as N/A, unable to do, extreme difficulty, moderate difficulty, slight difficulty, no difficulty, and/or a percentage (scale from 0-100, where higher scores indicate better physical function).
Outcome measures
| Measure |
Cartiva Hemiarthroplasty
n=9 Participants
Cartiva implant: The procedure starts with a small incision over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected, leaving approximately 2 mm of surrounding bone on the metatarsal head. A guide pin is placed within the metatarsal and a drill is then used to create a site for the implant. The implant is then placed using the implant introducer. The incision is then closed and a sterile dressing is placed.
|
Cheilectomy
n=10 Participants
Bone spur removal
Cheilectomy: A small incision is made over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected. The top of the metatarsal head is then cut with a sagittal saw. Additional bone spurs are resected. The incision is closed and a sterile dressing is placed.
|
|---|---|---|
|
Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-ADL) Questionnaire
Pre-operative
|
77.5 score on a scale
Standard Deviation 15.6
|
74 score on a scale
Standard Deviation 19.3
|
|
Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-ADL) Questionnaire
post-operative week 2
|
33 score on a scale
Standard Deviation NA
data from 1 participant
|
61 score on a scale
Standard Deviation NA
data from 1 participant
|
|
Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-ADL) Questionnaire
week 6
|
71 score on a scale
Standard Deviation 19.9
|
75 score on a scale
Standard Deviation 15.5
|
|
Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-ADL) Questionnaire
month 3
|
92 score on a scale
Standard Deviation 5.1
|
92 score on a scale
Standard Deviation 23.3
|
|
Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-ADL) Questionnaire
year 1
|
89 score on a scale
Standard Deviation 7.2
|
95 score on a scale
Standard Deviation 20.3
|
PRIMARY outcome
Timeframe: pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2Population: Study was terminated before the final time point per protocol.
The Foot and Ankle Ability Measure (FAAM-Sports) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. FAAM-Sports Questionnaire is an 8-item survey: scored as N/A, unable to do, extreme difficulty, moderate difficulty, slight difficulty, no difficulty, and/or a percentage (scale from 0-100, where higher scores indicate higher level of physical function).
Outcome measures
| Measure |
Cartiva Hemiarthroplasty
n=9 Participants
Cartiva implant: The procedure starts with a small incision over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected, leaving approximately 2 mm of surrounding bone on the metatarsal head. A guide pin is placed within the metatarsal and a drill is then used to create a site for the implant. The implant is then placed using the implant introducer. The incision is then closed and a sterile dressing is placed.
|
Cheilectomy
n=10 Participants
Bone spur removal
Cheilectomy: A small incision is made over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected. The top of the metatarsal head is then cut with a sagittal saw. Additional bone spurs are resected. The incision is closed and a sterile dressing is placed.
|
|---|---|---|
|
Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-Sports) Questionnaire
pre-operative
|
68 score on a scale
Standard Deviation 21.7
|
60.5 score on a scale
Standard Deviation 29.7
|
|
Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-Sports) Questionnaire
post-operative week 2
|
6 score on a scale
Standard Deviation NA
data from 1 participant
|
19 score on a scale
Standard Deviation NA
data from 1 participant
|
|
Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-Sports) Questionnaire
week 6
|
18 score on a scale
Standard Deviation 21.5
|
31.5 score on a scale
Standard Deviation 13.4
|
|
Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-Sports) Questionnaire
month 3
|
67 score on a scale
Standard Deviation 24.3
|
78 score on a scale
Standard Deviation 30.5
|
|
Change in Foot and Ankle Ability: Assessment by Foot and Ankle Ability Measure (FAAM-Sports) Questionnaire
year 1
|
67.5 score on a scale
Standard Deviation 17.9
|
79 score on a scale
Standard Deviation 28.8
|
PRIMARY outcome
Timeframe: pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2Population: Study was terminated before the final time point per protocol.
The SF-36 is an indicator of overall health status. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability, higher scores = less disability
Outcome measures
| Measure |
Cartiva Hemiarthroplasty
n=9 Participants
Cartiva implant: The procedure starts with a small incision over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected, leaving approximately 2 mm of surrounding bone on the metatarsal head. A guide pin is placed within the metatarsal and a drill is then used to create a site for the implant. The implant is then placed using the implant introducer. The incision is then closed and a sterile dressing is placed.
|
Cheilectomy
n=10 Participants
Bone spur removal
Cheilectomy: A small incision is made over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected. The top of the metatarsal head is then cut with a sagittal saw. Additional bone spurs are resected. The incision is closed and a sterile dressing is placed.
|
|---|---|---|
|
Change in Patient Health: Assessment by Short Form-36 Physical Component Scores (SF-36 PCS) Questionnaire
Pre-operative
|
35.5 score on a scale
Standard Deviation 7.7
|
44.1 score on a scale
Standard Deviation 10.4
|
|
Change in Patient Health: Assessment by Short Form-36 Physical Component Scores (SF-36 PCS) Questionnaire
post-operative week 2
|
25.5 score on a scale
Standard Deviation 12.1
|
33.5 score on a scale
Standard Deviation 1.0
|
|
Change in Patient Health: Assessment by Short Form-36 Physical Component Scores (SF-36 PCS) Questionnaire
week 6
|
32.7 score on a scale
Standard Deviation 6.8
|
41.3 score on a scale
Standard Deviation 10.6
|
|
Change in Patient Health: Assessment by Short Form-36 Physical Component Scores (SF-36 PCS) Questionnaire
month 3
|
46.4 score on a scale
Standard Deviation 3.6
|
54 score on a scale
Standard Deviation 17.5
|
|
Change in Patient Health: Assessment by Short Form-36 Physical Component Scores (SF-36 PCS) Questionnaire
year 1
|
50.4 score on a scale
Standard Deviation 6.5
|
50.1 score on a scale
Standard Deviation 11.1
|
PRIMARY outcome
Timeframe: pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2Population: Study was terminated before the final time point per protocol.
The SF-36 is an indicator of overall health status. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability, higher scores = less disability
Outcome measures
| Measure |
Cartiva Hemiarthroplasty
n=9 Participants
Cartiva implant: The procedure starts with a small incision over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected, leaving approximately 2 mm of surrounding bone on the metatarsal head. A guide pin is placed within the metatarsal and a drill is then used to create a site for the implant. The implant is then placed using the implant introducer. The incision is then closed and a sterile dressing is placed.
|
Cheilectomy
n=10 Participants
Bone spur removal
Cheilectomy: A small incision is made over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected. The top of the metatarsal head is then cut with a sagittal saw. Additional bone spurs are resected. The incision is closed and a sterile dressing is placed.
|
|---|---|---|
|
Change in Patient Health: Assessment by Short Form-36 Mental Component Scores (SF-36 MCS) Questionnaire
Pre-operative
|
54.8 score on a scale
Standard Deviation 5.1
|
58.2 score on a scale
Standard Deviation 5.3
|
|
Change in Patient Health: Assessment by Short Form-36 Mental Component Scores (SF-36 MCS) Questionnaire
Post-operative week 2
|
55.8 score on a scale
Standard Deviation 4.0
|
57.8 score on a scale
Standard Deviation 16.6
|
|
Change in Patient Health: Assessment by Short Form-36 Mental Component Scores (SF-36 MCS) Questionnaire
week 6
|
59.5 score on a scale
Standard Deviation 3.0
|
58.65 score on a scale
Standard Deviation 3.7
|
|
Change in Patient Health: Assessment by Short Form-36 Mental Component Scores (SF-36 MCS) Questionnaire
month 3
|
55.8 score on a scale
Standard Deviation 7.1
|
55.6 score on a scale
Standard Deviation 8.7
|
|
Change in Patient Health: Assessment by Short Form-36 Mental Component Scores (SF-36 MCS) Questionnaire
year 1
|
58.3 score on a scale
Standard Deviation 4.1
|
58.2 score on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2Population: Study was terminated before the final time point per protocol.
This is a measure of the amount of dorsiflexion of the first metatarsophalangeal joint. It is performed by the clinician and measured with a protractor in clinic. It was measured preoperatively and post operatively.
Outcome measures
| Measure |
Cartiva Hemiarthroplasty
n=9 Participants
Cartiva implant: The procedure starts with a small incision over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected, leaving approximately 2 mm of surrounding bone on the metatarsal head. A guide pin is placed within the metatarsal and a drill is then used to create a site for the implant. The implant is then placed using the implant introducer. The incision is then closed and a sterile dressing is placed.
|
Cheilectomy
n=10 Participants
Bone spur removal
Cheilectomy: A small incision is made over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected. The top of the metatarsal head is then cut with a sagittal saw. Additional bone spurs are resected. The incision is closed and a sterile dressing is placed.
|
|---|---|---|
|
Change in First MTP Peak Active Dorsiflexion
Pre-operative
|
30 degrees
Standard Deviation 8.8
|
30 degrees
Standard Deviation 13.4
|
|
Change in First MTP Peak Active Dorsiflexion
Post-operative week 2
|
33.5 degrees
Standard Deviation 16.3
|
45 degrees
Standard Deviation 8.7
|
|
Change in First MTP Peak Active Dorsiflexion
6 weeks
|
33.5 degrees
Standard Deviation 15.8
|
35 degrees
Standard Deviation 12.4
|
|
Change in First MTP Peak Active Dorsiflexion
3 months
|
47 degrees
Standard Deviation 12.7
|
50 degrees
Standard Deviation 21.4
|
|
Change in First MTP Peak Active Dorsiflexion
year 1
|
35 degrees
Standard Deviation 14.3
|
45 degrees
Standard Deviation 14
|
SECONDARY outcome
Timeframe: pre-operative baseline, post-operative Week 2, Week 6, Month 3, Year 1, and Year 2Population: Study was terminated before the final time point per protocol.
The VAS for pain is measured on a 0 to 100 point scale where 0 represents no pain and 100 indicates pain as bad as it could possibly be.
Outcome measures
| Measure |
Cartiva Hemiarthroplasty
n=9 Participants
Cartiva implant: The procedure starts with a small incision over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected, leaving approximately 2 mm of surrounding bone on the metatarsal head. A guide pin is placed within the metatarsal and a drill is then used to create a site for the implant. The implant is then placed using the implant introducer. The incision is then closed and a sterile dressing is placed.
|
Cheilectomy
n=10 Participants
Bone spur removal
Cheilectomy: A small incision is made over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected. The top of the metatarsal head is then cut with a sagittal saw. Additional bone spurs are resected. The incision is closed and a sterile dressing is placed.
|
|---|---|---|
|
Change Visual Analog Scale (VAS) for Pain
Pre-operative
|
48 score on a scale
Standard Deviation 20.7
|
56 score on a scale
Standard Deviation 29.3
|
|
Change Visual Analog Scale (VAS) for Pain
Post-operative week 2
|
40 score on a scale
Standard Deviation NA
data from 1 participant
|
75 score on a scale
Standard Deviation NA
data from 1 participant
|
|
Change Visual Analog Scale (VAS) for Pain
week 6
|
40 score on a scale
Standard Deviation 36
|
30 score on a scale
Standard Deviation 35.4
|
|
Change Visual Analog Scale (VAS) for Pain
month 3
|
7 score on a scale
Standard Deviation 6.1
|
10 score on a scale
Standard Deviation 32.7
|
|
Change Visual Analog Scale (VAS) for Pain
year 1
|
17 score on a scale
Standard Deviation 13.4
|
2 score on a scale
Standard Deviation 17.6
|
Adverse Events
Cartiva Hemiarthroplasty
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cheilectomy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cartiva Hemiarthroplasty
n=9 participants at risk
Cartiva implant
Cartiva Implant: Cartiva hemiarthroplasty: The procedure starts with a small incision over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected, leaving approximately 2 mm of surrounding bone on the metatarsal head. A guide pin is placed within the metatarsal and a drill is then used to create a site for the implant. The implant is then placed using the implant introducer. The incision is then closed and a sterile dressing is placed.
|
Cheilectomy
n=10 participants at risk
Bone spur removal
Cheilectomy: Cheilectomy: A small incision is made over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected. The top of the metatarsal head is then cut with a sagittal saw. Additional bone spurs are resected. The incision is closed and a sterile dressing is placed.
|
|---|---|---|
|
Infections and infestations
Wound Dehiscence
|
0.00%
0/9 • up to 1.5 years
|
10.0%
1/10 • Number of events 1 • up to 1.5 years
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1 • up to 1.5 years
|
10.0%
1/10 • Number of events 1 • up to 1.5 years
|
|
Surgical and medical procedures
Arthrodesis
|
0.00%
0/9 • up to 1.5 years
|
10.0%
1/10 • Number of events 1 • up to 1.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place