Trial Outcomes & Findings for Operative and Non-operative Treatment of Traumatic Arthrotomies (NCT NCT02841644)

Results Overview

To compare the cost of medical care in patients with traumatic arthrotomies treated with surgical irrigation and debridement versus non-operative treatment with local wound care. To estimate cost associated with TAs, total charge data was acquired for all patients treated at the lead site.

Recruitment status

COMPLETED

Target enrollment

180 participants

Primary outcome timeframe

12 months

Results posted on

2022-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Traumatic Arthrotomy- Treated Nonoperatively Patient diagnosed with traumatic arthrotomy treated nonoperatively. Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy.	Traumatic Arthrotomy- Treated Operatively Patient diagnosed with traumatic arthrotomy treated operatively. Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy.
Overall Study STARTED	60	120
Overall Study COMPLETED	60	120
Overall Study NOT COMPLETED	0	0

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	Traumatic Arthrotomy- Treated Nonoperatively n=60 Participants Patient diagnosed with traumatic arthrotomy treated nonoperatively. Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy.	Traumatic Arthrotomy- Treated Operatively n=120 Participants Patient diagnosed with traumatic arthrotomy treated operatively. Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy.	Total n=180 Participants Total of all reporting groups
Age, Continuous	31 years n=60 Participants	28.6 years n=120 Participants	30.5 years n=180 Participants
Sex: Female, Male Female	17 Participants n=60 Participants	34 Participants n=120 Participants	51 Participants n=180 Participants
Sex: Female, Male Male	43 Participants n=60 Participants	86 Participants n=120 Participants	129 Participants n=180 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 12 months

Population: We were unable to obtain total charges from half of our our patient population.

To compare the cost of medical care in patients with traumatic arthrotomies treated with surgical irrigation and debridement versus non-operative treatment with local wound care. To estimate cost associated with TAs, total charge data was acquired for all patients treated at the lead site.

Outcome measures

Outcome measures
Measure	Traumatic Arthrotomy- Treated Nonoperatively n=23 Participants Patient diagnosed with traumatic arthrotomy treated nonoperatively. Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy.	Traumatic Arthrotomy- Treated Operatively n=67 Participants Patient diagnosed with traumatic arthrotomy treated operatively. Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy.
Cost of Treatments	1089 USD Interval 55.0 to	11,973 USD Interval 863.0 to

PRIMARY outcome

Timeframe: 12 months

Complications were defined as septic arthritis, return to the OR, rehospitalization, and osteomyelitis of the injured joint.

Outcome measures

Outcome measures
Measure	Traumatic Arthrotomy- Treated Nonoperatively n=60 Participants Patient diagnosed with traumatic arthrotomy treated nonoperatively. Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy.	Traumatic Arthrotomy- Treated Operatively n=120 Participants Patient diagnosed with traumatic arthrotomy treated operatively. Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy.
Complications	4 Participants	18 Participants

SECONDARY outcome

Timeframe: baseline, 3 months

Population: Missing VR-12 from 69 patients.

The veteran rand 12-tem health survey is used to determine change in health related quality of life to estimate disease burden. It is summarized into two scores, a physical component scores (PCS) (range 0-100) and mental component scores (range- 0-100). Higher score indicate better outcomes.

Outcome measures

Outcome measures
Measure	Traumatic Arthrotomy- Treated Nonoperatively n=28 Participants Patient diagnosed with traumatic arthrotomy treated nonoperatively. Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy.	Traumatic Arthrotomy- Treated Operatively n=83 Participants Patient diagnosed with traumatic arthrotomy treated operatively. Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy.
Comparing 3-Month Change in Veterans RAND 12-Item Health Survey (VR-12) by Treatment Method VR-12 Physical Health: Baseline	49 score on a scale Standard Deviation 6.9	48.1 score on a scale Standard Deviation 10.6
Comparing 3-Month Change in Veterans RAND 12-Item Health Survey (VR-12) by Treatment Method VR-12 Mental Health: Baseline	50.7 score on a scale Standard Deviation 11.2	51.8 score on a scale Standard Deviation 10.9
Comparing 3-Month Change in Veterans RAND 12-Item Health Survey (VR-12) by Treatment Method VR-12 Physical Health: 3 month	36.9 score on a scale Standard Deviation 11.4	32.1 score on a scale Standard Deviation 12.3
Comparing 3-Month Change in Veterans RAND 12-Item Health Survey (VR-12) by Treatment Method VR-12 Mental Health: 3 Month	41.9 score on a scale Standard Deviation 7.4	46.8 score on a scale Standard Deviation 8.9
Comparing 3-Month Change in Veterans RAND 12-Item Health Survey (VR-12) by Treatment Method VR-12 Physical Health: Difference	-12.2 score on a scale Standard Deviation 12.7	-16.0 score on a scale Standard Deviation 15.3
Comparing 3-Month Change in Veterans RAND 12-Item Health Survey (VR-12) by Treatment Method VR-12 Mental Health: Difference	-8.8 score on a scale Standard Deviation 10.5	-5.1 score on a scale Standard Deviation 12.3

Adverse Events

Traumatic Arthrotomy- Treated Nonoperatively

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traumatic Arthrotomy- Treated Operatively

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

Vice Chair of Research

Atrium Health

Phone: 7043552000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place