NCT04034043: APT

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

Completed Results posted Last updated 12 November 2019

What this trial tests

trial testing ceramic-on-ceramic total hip arthroplasty in Hip Osteoarthritis in 68 participants. Completed in 20 August 2019.

Timeline

15 July 2019

Primary endpoint
19 July 2019

20 August 2019

Quick facts

Lead sponsor	Istituto Ortopedico Rizzoli
Status	Completed
Study type	OBSERVATIONAL
Enrollment	68
Start date	15 July 2019
Primary completion	19 July 2019
Estimated completion	20 August 2019
Sites	1 location across Italy

Drugs / interventions tested

• ceramic-on-ceramic total hip arthroplasty

Conditions studied

• Hip Osteoarthritis — all drugs for Hip Osteoarthritis →
• Post-traumatic Osteoarthritis — all drugs for Post-traumatic Osteoarthritis →

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

18 and older, any sex, with Hip Osteoarthritis or Post-traumatic Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Survival Rates of the Hip Implants Primary · 10 years-18 years

Kaplan Meier curve with 95% confidence intervals

Group	Value	95% CI
THA Post Acetabular Fractures	96.3	86.1 – 99.1

Clinical Outcomes of the Hip Implants Primary · 10 years-18 years

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

Group	Value	95% CI
THA Post Acetabular Fractures	88.4	± 11.6

Clinical Outcomes of the Hip Implants Primary · 10 years -18 years

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

Group	Value	95% CI
THA Post Acetabular Fractures	84.3	± 9.6

Percentage of Patients With Adequate Radiographic Cup Osseointegration Primary · 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

Group	Value	95% CI
THA Post Acetabular Fractures	68

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 years-18 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

THA Post Acetabular Fractures

Serious: 8/68 (12%)

Deaths: 0/68

Serious adverse events (3 terms)

Reaction	System	THA Post Acetabular Fractu…
modular neck failure	Musculoskeletal and connective tissue disorders	—
periprosthetic fracture	Musculoskeletal and connective tissue disorders	—
Aseptic loosening of the stem	Musculoskeletal and connective tissue disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	THA Post Acetabular Fractu…
Dislocation not requiring revision surgery	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: modular neck failure, periprosthetic fracture, Aseptic loosening of the stem.

Data from ClinicalTrials.gov NCT04034043 adverse events section.

Sponsor's own description

A retrospective consecutive population of patients treated with cementless total hip arthroplasty with ceramic-on-ceramic bearing surfaces due to post-traumatic osteoarthritis due to acetabular fractures will be selected. The aim of this retrospective study is to evaluate the long-term clinical and radiographic results of this implant in such a specific cohort. The secondary aim of the sudy is to provide the complication rate and the failure rate of the cohort. A descriptive analysis of the failures will be provided as well.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.