Trial Outcomes & Findings for A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Knee Osteoarthritis (NCT NCT03257371)

Results Overview

patient reported Visual Analogue Scale Pain Score, 0 no pain, 10 maximum pain

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

12 months

Results posted on

2021-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	Post-traumatic Knee OA post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Post-traumatic Knee OA post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Post-traumatic Knee OA n=10 Participants post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants
Age, Continuous	41.4 years n=10 Participants
Sex: Female, Male Female	2 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 7 patients completed the study without needing revision/TKA surgery or being lost to follow-up

patient reported Visual Analogue Scale Pain Score, 0 no pain, 10 maximum pain

Outcome measures

Outcome measures
Measure	Post-traumatic Knee OA n=7 Participants post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
Visual Analogue Scale Pain Score	2.3 units on a scale Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: 12 months

Patient reported outcome scale related to work and sporting activities, The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.

Outcome measures

Outcome measures
Measure	Post-traumatic Knee OA n=7 Participants post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
Tegner Activity Level Scale	3.3 units on a scale Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 12 months

Knee specific patient reported outcome, ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.

Outcome measures

Outcome measures
Measure	Post-traumatic Knee OA n=7 Participants post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
International Knee Documentation Committee (IKDC) Total Score	50.6 units on a scale Interval 39.1 to 64.4

SECONDARY outcome

Timeframe: 12 months

A survey related to physical function and mobility, T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric: A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. A higher score is better for this outcome measure as it indicates more function/mobility compared to the mean of the reference population.

Outcome measures

Outcome measures
Measure	Post-traumatic Knee OA n=7 Participants post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
PROMIS - Physical Function and Mobility Physical Function	41.2 units on a scale Interval 27.7 to 46.6
PROMIS - Physical Function and Mobility Mobility	43.1 units on a scale Interval 37.7 to 47.9

Adverse Events

Post-traumatic Knee OA

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Post-traumatic Knee OA n=10 participants at risk post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
Musculoskeletal and connective tissue disorders Revision or TKA surgery	20.0% 2/10 • Number of events 2 • AE data was followed for one year. AE: I. Bleeding II. Infection III. Pain that is uncontrolled with standard post-operative analgesia protocol SAE: I. Bleeding that is significant enough to require extended hospitalization or unplanned critical care interventions II. Infection that is significant enough to require extended hospitalization or unplanned critical care interventions III. Pain that is significant enough to require extended hospitalization or unplanned critical care interventions

Other adverse events

Other adverse events
Measure	Post-traumatic Knee OA n=10 participants at risk post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
Musculoskeletal and connective tissue disorders Bone Grafting	10.0% 1/10 • Number of events 1 • AE data was followed for one year. AE: I. Bleeding II. Infection III. Pain that is uncontrolled with standard post-operative analgesia protocol SAE: I. Bleeding that is significant enough to require extended hospitalization or unplanned critical care interventions II. Infection that is significant enough to require extended hospitalization or unplanned critical care interventions III. Pain that is significant enough to require extended hospitalization or unplanned critical care interventions
Musculoskeletal and connective tissue disorders Knee Arthroscopy	30.0% 3/10 • Number of events 3 • AE data was followed for one year. AE: I. Bleeding II. Infection III. Pain that is uncontrolled with standard post-operative analgesia protocol SAE: I. Bleeding that is significant enough to require extended hospitalization or unplanned critical care interventions II. Infection that is significant enough to require extended hospitalization or unplanned critical care interventions III. Pain that is significant enough to require extended hospitalization or unplanned critical care interventions

Additional Information

Dr. James Cook

University of Missouri

Phone: 573-882-7189

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place