Trial Outcomes & Findings for Weightbearing Assessment of Tarsal Instability (NCT NCT01868789)

Results Overview

Relative motion, which is the position of the full weightbearing (FWB, greater that 75-100% body weight) navicular in comparison to the touch down weightbearing (TDWB, 25-50% body weight) navicular position, will be determined by comparing the joint orientation across these two points on one CT scan. The difference between the two positions is reported below.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing

Results posted on

2018-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Weightbearing CT (AAFD Group) Weightbearing CT scan of affected foot Weightbearing CT	Weightbearing CT (Control Group) Weightbearing CT scan of normal foot Weightbearing CT
Overall Study STARTED	9	14
Overall Study COMPLETED	7	12
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Weightbearing CT (AAFD Group) n=7 Participants Weightbearing CT scan of affected foot Weightbearing CT	Weightbearing CT (Control Group) n=12 Participants Weightbearing CT scan of normal foot Weightbearing CT	Total n=19 Participants Total of all reporting groups
Age, Continuous	43.6 years n=7 Participants	52.2 years n=12 Participants	49.0 years n=19 Participants
Sex: Female, Male Female	3 Participants n=7 Participants	10 Participants n=12 Participants	13 Participants n=19 Participants
Sex: Female, Male Male	4 Participants n=7 Participants	2 Participants n=12 Participants	6 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	7 participants n=7 Participants	12 participants n=12 Participants	19 participants n=19 Participants

PRIMARY outcome

Timeframe: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing

Relative motion, which is the position of the full weightbearing (FWB, greater that 75-100% body weight) navicular in comparison to the touch down weightbearing (TDWB, 25-50% body weight) navicular position, will be determined by comparing the joint orientation across these two points on one CT scan. The difference between the two positions is reported below.

Outcome measures

Outcome measures
Measure	Weightbearing CT (AAFD Group) n=7 Participants Weightbearing CT scan of affected foot Weightbearing CT	Weightbearing CT (Control Group) n=12 Participants Weightbearing CT scan of normal foot Weightbearing CT
Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular Translation of the Navicular	3.56 mm Standard Deviation 2.15	4.36 mm Standard Deviation 2.16
Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular axis of navicular rotation: x component	-0.1666 mm Standard Deviation 0.338	-0.170 mm Standard Deviation 0.188
Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular axis of navicular rotation: y component	0.867 mm Standard Deviation 0.159	0.950 mm Standard Deviation 0.045
Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular axis of navicular rotation: z component	-0.083 mm Standard Deviation 0.331	0.084 mm Standard Deviation 0.171

PRIMARY outcome

Timeframe: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing

Relative motion across joint segments will be determined by comparing the joint orientation across two time points: touch-down bearing (TDWB, 25-50% body weight) and full-weight bearing (FWB, greater that 75-100% body weight) as measured on CT.

Outcome measures

Outcome measures
Measure	Weightbearing CT (AAFD Group) n=7 Participants Weightbearing CT scan of affected foot Weightbearing CT	Weightbearing CT (Control Group) n=12 Participants Weightbearing CT scan of normal foot Weightbearing CT
Change in Navicular Rotation Between Touch-down Bearing and Full-weight Bearing	4.11 degrees Standard Deviation 2.19	5.99 degrees Standard Deviation 3.26

Adverse Events

Weightbearing CT (AAFD Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Weightbearing CT (Control Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gregory Berlet

Orthopedic Foot and Ankle Center

Phone: 6148958747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place