Trial Outcomes & Findings for Trident II Revision Outcomes Study (NCT NCT04317586)

NCT ID: NCT04317586

Last Updated: 2023-12-01

Results Overview

To demonstrate, through absence of revision for aseptic loosening at five years postoperative, that acetabular revision with the Trident II Acetabular Shell provides clinical results comparable to similar acetabular components for revision indications. The study was terminated prior to the 5-year timepoint, data is presented through 2-years postoperative.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: 6 Weeks, 3-6 Months, 1 Year and 2 Years
• Results posted on: 2023-12-01

Participant Flow

Unit of analysis: Hips Implanted

Participant milestones

Measure	Trident II Tritanium Acetabular Shell for Revision Trident II Tritanium Acetabular Shell for Revision: A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)
Overall Study STARTED	16 17
Overall Study COMPLETED	0 0
Overall Study NOT COMPLETED	16 17

Reasons for withdrawal

Measure	Trident II Tritanium Acetabular Shell for Revision Trident II Tritanium Acetabular Shell for Revision: A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)
Overall Study Participants/Hips Implanted Censored from Analysis	2
Overall Study Participants Terminated Early (*15 Hips Implanted)	14

Baseline Characteristics

Trident II Revision Outcomes Study

Baseline characteristics by cohort

Measure	Trident II Tritanium Acetabular Shell for Revision n=15 Hips Implanted Trident II Tritanium Acetabular Shell for Revision: A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)
Age, Continuous	67.5 years STANDARD_DEVIATION 8.13 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	2 Participants n=5 Participants
Race (NIH/OMB) White	12 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 United States	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Weeks, 3-6 Months, 1 Year and 2 Years

Population: One subject (1 Hip Implanted) did not return for a 6-Week Post-Operative Visit. Data are presented for 14 implanted for latest follow-up timepoint reached by each subject; presented at 6 Weeks (N=14 Hips Implanted), 3-6 Months (N=11 Hips Implanted), 1 Year (N=8 Hips Implanted) and 2 Years (N=2 Hips Implanted).

To demonstrate, through absence of revision for aseptic loosening at five years postoperative, that acetabular revision with the Trident II Acetabular Shell provides clinical results comparable to similar acetabular components for revision indications. The study was terminated prior to the 5-year timepoint, data is presented through 2-years postoperative.

Outcome measures

Measure	Trident II Tritanium Acetabular Shell for Revision n=14 Hips Implanted Trident II Tritanium Acetabular Shell for Revision: A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)
Number of Cases Free From Trident II Acetabular Shell Revision Number of Hips Free From Revision at 6 Weeks	14 Hips Implanted
Number of Cases Free From Trident II Acetabular Shell Revision Number of Hips Free From Revision at 3-6 Months	11 Hips Implanted
Number of Cases Free From Trident II Acetabular Shell Revision Number of Hips Free From Revision at 1 Year	8 Hips Implanted
Number of Cases Free From Trident II Acetabular Shell Revision Number of Hips Free From Revision at 2 Years	2 Hips Implanted

SECONDARY outcome

Timeframe: 6 Weeks and 3-6 Months

Population: Data reviewed by Independent Radiographic Reviewer is presented for one subject (1 Hip Implanted) at the 6 week and 3-6 Month timepoint. Following the initial review of 1 subject, the decision to terminate the study was made. No further radiographic review was conducted, and no additional radiographic stability data was collected.

Radiographic stability is a composite endpoint evaluating radiolucency and migration. Radiographic stability is defined as cases (hips implanted) which do not present with migration of greater than 5 mm in any direction or at least 2 mm radiolucency in all zones.

Outcome measures

Measure	Trident II Tritanium Acetabular Shell for Revision n=1 Hips Implanted Trident II Tritanium Acetabular Shell for Revision: A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)
Radiographic Stability Hips Implanted that are Radiographically Stable at 6-Weeks	1 Hips Implanted
Radiographic Stability Hips Implanted that are Radiographically Stable at 3-6 Months	1 Hips Implanted

Adverse Events

Trident II Tritanium Acetabular Shell for Revision

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Trident II Tritanium Acetabular Shell for Revision n=14 participants at risk Trident II Tritanium Acetabular Shell for Revision: A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)
Musculoskeletal and connective tissue disorders Deep Joint Infection	7.1% 1/14 • Number of events 1 • Adverse event data was collected from date of surgery to date of early termination, which was up to the 2 Year timepoint for the earliest enrolled subject. No difference of adverse event definition.

Other adverse events

Adverse event data not reported

Additional Information

Kevin Barga

Stryker

Phone: 2018315073

Email: kevin.barga@stryker.com

Results disclosure agreements

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

Restriction type: LTE60