Trial Outcomes & Findings for Pending Failure in Hard-hard Total Hip Arthroplasty (NCT NCT02427984)

NCT ID: NCT02427984

Last Updated: 2016-05-25

Results Overview

Measured by Inductively coupled plasma mass spectrometry (ICP-MS), equipped with dynamic cell reaction (ELAN DRC II) and expressed in micrograms/liter. Will be counted the number of patients with level os metals above 7micrograms/liter This outcome is valuable only for MoM arm and Control arm (as comparison), because CoC arm patients don't wear device releasing this kind of metals.

• Recruitment status: COMPLETED
• Target enrollment: 148 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2016-05-25

Participant Flow

Participant milestones

Measure	Metal on Metal (MoM) All the patients of our Division with MoM THA	Controls	Ceramic on Ceramic (CoC) All the patients of our Division with CoC THA
Overall Study STARTED	53	45	50
Overall Study COMPLETED	40	40	32
Overall Study NOT COMPLETED	13	5	18

Reasons for withdrawal

Measure	Metal on Metal (MoM) All the patients of our Division with MoM THA	Controls	Ceramic on Ceramic (CoC) All the patients of our Division with CoC THA
Overall Study Lost to Follow-up	13	5	18

Baseline Characteristics

Pending Failure in Hard-hard Total Hip Arthroplasty

Baseline characteristics by cohort

Measure	Metal on Metal (MoM) n=40 Participants All the patients of our Division with MoM THA	Controls n=40 Participants All the patients of our Division for primary THA	Ceramic on Ceramic (CoC) n=32 Participants All the patients of our Division with CoC THA	Total n=112 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	60 Participants n=4 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	12 Participants n=5 Participants	52 Participants n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	25 Participants n=7 Participants	20 Participants n=5 Participants	65 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	47 Participants n=4 Participants

PRIMARY outcome

Timeframe: 3 years

Population: the population was evaluated as number of patients with ions level above 7ug/l (attention limit)

Measured by Inductively coupled plasma mass spectrometry (ICP-MS), equipped with dynamic cell reaction (ELAN DRC II) and expressed in micrograms/liter.

Will be counted the number of patients with level os metals above 7micrograms/liter

This outcome is valuable only for MoM arm and Control arm (as comparison), because CoC arm patients don't wear device releasing this kind of metals.

Outcome measures

Measure	Metal on Metal (MoM) n=40 Participants	Control n=40 Participants
Number of Participants With Chromium and Cobalt Ion Levels Above 7ug/l	14 participants above limit	0 participants above limit

PRIMARY outcome

Timeframe: 3 years

Measured by fast Fourier transform (FFT) expressed in duration (milliseconds)

This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)

Outcome measures

Measure	Metal on Metal (MoM) n=32 Participants	Control n=40 Participants
Duration of Articular Noise Produced During Level Walking	174 milliseconds Interval 40.0 to 300.0	40 milliseconds Interval 40.0 to 300.0

PRIMARY outcome

Timeframe: 3 years

Measured by fast Fourier transform (FFT) expressed in frequency (Hz) This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)

Outcome measures

Measure	Metal on Metal (MoM) n=32 Participants	Control n=40 Participants
Frequency of Articular Noise Produced During Level Walking	910 Hz Interval 100.0 to 1500.0	100 Hz Interval 100.0 to 1500.0

PRIMARY outcome

Timeframe: 3 years

Measured by fast Fourier transform (FFT) expressed in amplitude (decibel) This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)

Outcome measures

Measure	Metal on Metal (MoM) n=32 Participants	Control n=40 Participants
Amplitude of Articular Noise Produced During Level Walking	-20 decibel Interval -38.0 to -2.0	-38 decibel Interval -38.0 to -2.0

SECONDARY outcome

Timeframe: 3 years

Population: positive for ALVAL is +, negative for ALVAL is -

Histological score defined by the valuation of staining It was possible to valuate this outcome only for 29 out of 40 patients MoM (due to the availability of periprosthetic tissues).

The arms CoC and controls were not studied for this issue because ALVAL could occur only in presence of Metals

Outcome measures

Measure	Metal on Metal (MoM) n=29 Participants	Control
Number of Participants Who Scored Positive for ALVAL	15 participants	—

Adverse Events

Metal on Metal (MoM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ceramic on Ceramic (CoC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls

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

Susanna Stea

Medical technology laboratory, Rizzoli Orthopaedic Institute

Phone: 00390516366861

Email: stea@tecno.ior.it

Results disclosure agreements

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