Trial Outcomes & Findings for Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture (NCT NCT04034043)

NCT ID: NCT04034043

Last Updated: 2019-11-12

Results Overview

Kaplan Meier curve with 95% confidence intervals

• Recruitment status: COMPLETED
• Target enrollment: 68 participants
• Primary outcome timeframe: 10 years-18 years
• Results posted on: 2019-11-12

Participant Flow

Participant milestones

Measure	THA Post Acetabular Fractures Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture with a minimum follow-up of 10 years
Overall Study STARTED	68
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture

Baseline characteristics by cohort

Measure	THA Post Acetabular Fractures n=68 Participants Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture with a minimum follow-up of 10 years
Age, Continuous	47.6 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Italy	68 participants n=5 Participants
percentages of patients treated operatively	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 years-18 years

Kaplan Meier curve with 95% confidence intervals

Outcome measures

Measure	THA Post Acetabular Fractures n=68 Participants Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture with a minimum follow-up of 10 years
Survival Rates of the Hip Implants	96.3 percentage of non-revised implants Interval 86.1 to 99.1

PRIMARY outcome

Timeframe: 10 years-18 years

HHS score (Harris Hip Score). Total scale: 0-100. Best performance: 100

Outcome measures

Measure	THA Post Acetabular Fractures n=68 Participants Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture with a minimum follow-up of 10 years
Clinical Outcomes of the Hip Implants	88.4 score on a scale Standard Deviation 11.6

PRIMARY outcome

Timeframe: 10 years -18 years

WOMAC score (Western Ontario and McMaster Universities Osteoarthritis Index). Total scale: 0-96. Best performance: 96

Outcome measures

Measure	THA Post Acetabular Fractures n=68 Participants Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture with a minimum follow-up of 10 years
Clinical Outcomes of the Hip Implants	84.3 score on a scale Standard Deviation 9.6

PRIMARY outcome

Timeframe: 10 years-18 years

Percentage of patients with a good osseointegration defined by the criteria described by Moore et al. Measurement technique: qualitative visual assessment of 5 binary parameters (yes/no): radial trabeculae, stress shielding, superolateral buttress, inferomedial buttress, absence of radiolucent lines. Adequate osseointegration: at least 3 parameters are present. Total scale: 0%-100%. Best performance (every patient has adequate osseointegration at 10 years): 100

Outcome measures

Measure	THA Post Acetabular Fractures n=68 Participants Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture with a minimum follow-up of 10 years
Percentage of Patients With Adequate Radiographic Cup Osseointegration	68 Participants

Adverse Events

THA Post Acetabular Fractures

Serious events: 8 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	THA Post Acetabular Fractures n=60 participants at risk；n=68 participants at risk Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture with a minimum follow-up of 10 years
Musculoskeletal and connective tissue disorders modular neck failure	5.9% 4/68 • Number of events 4 • 10 years-18 years
Musculoskeletal and connective tissue disorders periprosthetic fracture	2.9% 2/68 • Number of events 2 • 10 years-18 years
Musculoskeletal and connective tissue disorders Aseptic loosening of the stem	2.9% 2/68 • Number of events 2 • 10 years-18 years

Other adverse events

Measure	THA Post Acetabular Fractures n=60 participants at risk；n=68 participants at risk Ceramic-on-ceramic THA for Post-traumatic Hip Osteoarthritis After Acetabular Fracture with a minimum follow-up of 10 years
Musculoskeletal and connective tissue disorders Dislocation not requiring revision surgery	3.3% 2/60 • Number of events 2 • 10 years-18 years

Additional Information

Federico Giardina

IRCSS Istituto Ortopedico Rizzoli

Phone: +390516366418

Email: federico.giardina@ior.it

Results disclosure agreements

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