Trial Outcomes & Findings for Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee (NCT NCT02254473)

Results Overview

Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Baseline

Results posted on

2019-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	Wedge Insert Patients will receive a wedge insert Wedge Insert	Flat Insert Patients will receive a flat insert Flat Insert
Overall Study STARTED	9	3
Overall Study COMPLETED	7	2
Overall Study NOT COMPLETED	2	1

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	Wedge Insert n=9 Participants Patients will receive a wedge insert Wedge Insert	Flat Insert n=3 Participants Patients will receive a flat insert Flat Insert	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=9 Participants	0 Participants n=3 Participants	5 Participants n=12 Participants
Age, Categorical >=65 years	4 Participants n=9 Participants	3 Participants n=3 Participants	7 Participants n=12 Participants
Sex: Female, Male Female	6 Participants n=9 Participants	1 Participants n=3 Participants	7 Participants n=12 Participants
Sex: Female, Male Male	3 Participants n=9 Participants	2 Participants n=3 Participants	5 Participants n=12 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=9 Participants	3 participants n=3 Participants	12 participants n=12 Participants

PRIMARY outcome

Timeframe: Baseline

Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.

Outcome measures

Outcome measures
Measure	Wedge Insert n=9 Participants Patients will receive a wedge insert Wedge Insert	Flat Insert n=3 Participants Patients will receive a flat insert Flat Insert
Patient Reported Function and Pain	3.66 score on a scale 0-10 (normal) Interval 1.0 to 6.0	4.66 score on a scale 0-10 (normal) Interval 4.0 to 5.0

PRIMARY outcome

Timeframe: 6 weeks

Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.

Outcome measures

Outcome measures
Measure	Wedge Insert n=9 Participants Patients will receive a wedge insert Wedge Insert	Flat Insert n=3 Participants Patients will receive a flat insert Flat Insert
Patient Reported Function and Pain	3.77 score on a scale 0-10 (normal) Interval 1.0 to 6.0	4 score on a scale 0-10 (normal) Interval 2.0 to 5.0

PRIMARY outcome

Timeframe: 3 months

Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.

Outcome measures

Outcome measures
Measure	Wedge Insert n=8 Participants Patients will receive a wedge insert Wedge Insert	Flat Insert n=3 Participants Patients will receive a flat insert Flat Insert
Patient Reported Function and Pain	3.88 score on a scale 0-10 (normal) Interval 1.0 to 7.0	3.66 score on a scale 0-10 (normal) Interval 2.0 to 5.0

PRIMARY outcome

Timeframe: 6 months

Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.

Outcome measures

Outcome measures
Measure	Wedge Insert n=6 Participants Patients will receive a wedge insert Wedge Insert	Flat Insert n=2 Participants Patients will receive a flat insert Flat Insert
Patient Reported Function and Pain	3.66 score on a scale 0-10 (normal) Interval 1.0 to 6.0	3.5 score on a scale 0-10 (normal) Interval 2.0 to 5.0

PRIMARY outcome

Timeframe: 9 months

Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.

Outcome measures

Outcome measures
Measure	Wedge Insert n=8 Participants Patients will receive a wedge insert Wedge Insert	Flat Insert n=2 Participants Patients will receive a flat insert Flat Insert
Patient Reported Function and Pain	3.88 score on a scale 0-10 (normal) Interval 1.0 to 7.0	4 score on a scale 0-10 (normal) Interval 3.0 to 5.0

PRIMARY outcome

Timeframe: 12 months

Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.

Outcome measures

Outcome measures
Measure	Wedge Insert n=6 Participants Patients will receive a wedge insert Wedge Insert	Flat Insert n=2 Participants Patients will receive a flat insert Flat Insert
Patient Reported Function and Pain	3.17 score on a scale 0-10 (normal) Interval 1.0 to 6.0	4 score on a scale 0-10 (normal) Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: Baseline

Population: Data was not gathered due to pre-mature termination of the study.

X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Data was not gathered due to pre-mature termination of the study.

X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).

Outcome measures

Outcome data not reported

Adverse Events

Wedge Insert

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Flat Insert

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Wedge Insert n=9 participants at risk Patients will receive a wedge insert Wedge Insert	Flat Insert n=3 participants at risk Patients will receive a flat insert Flat Insert
Musculoskeletal and connective tissue disorders Pain	11.1% 1/9 • Number of events 1 • 1 year	0.00% 0/3 • 1 year

Additional Information

Megan Reams

TRIA Orthopaedic Center

Phone: 952-806-5329

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place