Trial Outcomes & Findings for Wedged Orthoses and Knee Osteoarthritis (NCT NCT00420147)

NCT ID: NCT00420147

Last Updated: 2017-06-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2017-06-16

Participant Flow

Participant milestones

Measure	Medial Knee OA - Control These subjects have tibio-femoral medial knee compartment osteoarthritis and were prescribed a neutral in shoe orthosis	Medial Knee OA - Treatment These subjects have tibio-femoral medial knee compartment osteoarthritis and were prescribed a laterally wedged in shoe orthosis
Overall Study STARTED	19	19
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Wedged Orthoses and Knee Osteoarthritis

Baseline characteristics by cohort

Measure	Medial Knee OA - Control n=19 Participants These subjects have tibio-femoral medial knee compartment osteoarthritis and wore a neutral (non-wedged) in-shoe orthosis as their treatment.	Medial Knee OA - Treatment n=19 Participants These subjects have tibio-femoral medial knee compartment osteoarthritis and wore a wedged in-shoe orthosis as their treatment.	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	62.8 years STANDARD_DEVIATION 9.6 • n=5 Participants	62.0 years STANDARD_DEVIATION 7.4 • n=7 Participants	62.4 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Measure	Medial Knee OA - Control n=19 Participants These subjects have tibio-femoral medial knee compartment osteoarthritis	Medial Knee OA - Treatment n=19 Participants These subjects have tibio-femoral medial knee compartment osteoarthritis
Knee Adduction Moment at Baseline	0.376 Nm/(kg-m) Standard Deviation 0.118	0.342 Nm/(kg-m) Standard Deviation 0.131

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Medial Knee OA - Control n=19 Participants These subjects have tibio-femoral medial knee compartment osteoarthritis	Medial Knee OA - Treatment n=19 Participants These subjects have tibio-femoral medial knee compartment osteoarthritis
Knee Adduction Moment After 12 Months	0.408 Nm/(kg-m) Standard Deviation 0.108	0.358 Nm/(kg-m) Standard Deviation 0.127

Adverse Events

Medial Knee OA - Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Medial Knee OA - Treatment

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

Todd Royer

University of Delaware

Phone: 302-831-4351

Email: royer@udel.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place