Trial Outcomes & Findings for A Biomarker Stress Test for Detection of Early Osteoarthritis (NCT NCT02593864)

Last Updated: 2020-11-20

Results Overview

Knee adduction moment describes the medial/lateral load distribution of the knee measured while walking in a gait laboratory. Before normalization to account for size, the knee adduction moment is expressed in Nm. However, to account for different sized people, the knee adduction moment is transformed and expressed in percentage of body weight times height (%BW\*ht). Higher knee adduction moments have been linked to more severe osteoarthritis (OA). Knee adduction moment will be analyzed at baseline and after 6 months of variable-stiffness shoe wear. Values at 6 months (in variable-stiffness shoe) will be compared to baseline (in control shoe).

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2020-11-20

Participant Flow

X-ray screening for inclusion/exclusion criteria

Participant milestones

Participant milestones
Measure	Variable-Stiffness Shoe Subjects will wear a load-modifying variable-stiffness shoe for 6 months Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading
Overall Study STARTED	25
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Variable-Stiffness Shoe Subjects will wear a load-modifying variable-stiffness shoe for 6 months Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	3

Baseline Characteristics

Per protocol cohort. Baseline value of subjects who completed the 6 month study visit. Gait data unusable for 1 subject at follow-up, and this subject was not included in the baseline value.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Variable-Stiffness Shoe n=25 Participants Subjects will wear a load-modifying variable-stiffness shoe for 6 months Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading
Age, Continuous	58.6 years STANDARD_DEVIATION 10.9 • n=25 Participants
Sex: Female, Male Female	8 Participants n=25 Participants
Sex: Female, Male Male	17 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants
Race (NIH/OMB) Asian	3 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants
Race (NIH/OMB) Black or African American	3 Participants n=25 Participants
Race (NIH/OMB) White	18 Participants n=25 Participants
Race (NIH/OMB) More than one race	1 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants
Region of Enrollment United States	25 participants n=25 Participants
Knee Adduction Moment	2.67 %Bw*Ht STANDARD_DEVIATION 0.76 • n=18 Participants • Per protocol cohort. Baseline value of subjects who completed the 6 month study visit. Gait data unusable for 1 subject at follow-up, and this subject was not included in the baseline value.
COMP at 3.5 Hours (% Of Baseline Resting)	84.4 % Of Resting STANDARD_DEVIATION 11.1 • n=15 Participants • Per protocol cohort. These analyses are based on available data from 15 subjects who completed both the baseline and follow-up visits for analysis of changes in COMP. Biomarker data for one subject was missing at baseline, and complete biomarker data for 3 subjects was unable to be collected at follow-up.

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: These results were based on gait data for 18 subjects that was available at both the baseline and follow-up visits

Outcome measures

Outcome measures
Measure	Variable-Stiffness Shoe n=18 Participants Subjects will wear a load-modifying variable-stiffness shoe for 6 months Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading
Change at 6 Months From Baseline in First Peak Knee Adduction Moment (KAM): (6 Month Value - Baseline)	-0.19 %Bw*Ht Standard Deviation 0.17

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: These analyses were based on available data from 15 subjects at both the baseline and follow-up visits for analysis of changes in COMP

Serum samples were collected before and after a 30 minute walking activity. Levels of serum cartilage oligomeric matrix protein (COMP) 3.5 hours following the 30-minute walk, expressed as a percentage of pre-activity resting values, were assessed, and values at 6 months were compared to baseline.

Outcome measures

Outcome measures
Measure	Variable-Stiffness Shoe n=15 Participants Subjects will wear a load-modifying variable-stiffness shoe for 6 months Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading
Change at 6 Months From Baseline in Serum COMP Biomarker Levels in Response to a Mechanical Stimulus (6 Month - Baseline)	-0.8 Percent of Resting Standard Deviation 10.3

Adverse Events

Variable-Stiffness Shoe

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Variable-Stiffness Shoe n=25 participants at risk Subjects will wear a load-modifying variable-stiffness shoe for 6 months Variable-Stiffness Shoe: A load-modifying variable-stiffness shoe previously shown to reduce joint loading
Musculoskeletal and connective tissue disorders Joint paint	28.0% 7/25 • Number of events 8 • 6 Months

Additional Information

Constance Chu, MD

Stanford University

Phone: 650-723-5643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place