Trial Outcomes & Findings for Signature Acetabular Posterior/Lateral Data Collection (NCT NCT02220478)

Results Overview

Average operative time

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Surgery

Results posted on

2022-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	Signature Cutting Guides Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery. Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.	Conventional Instrumentation Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery. Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.
Overall Study STARTED	14	10
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Signature Acetabular Posterior/Lateral Data Collection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Signature Cutting Guides n=14 Participants Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery. Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.	Conventional Instrumentation n=10 Participants Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery. Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.	Total n=24 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 9.9 • n=5 Participants	68.8 years STANDARD_DEVIATION 6.4 • n=7 Participants	62.1 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants	0 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment France	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Surgery

Average operative time

Outcome measures

Outcome measures
Measure	Signature Cutting Guides n=14 Participants Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery. Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.	Conventional Instrumentation n=10 Participants Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery. Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.
Operative Room Time	84.7 minutes Standard Deviation 12.0	78.3 minutes Standard Deviation 3.8

Adverse Events

Signature Cutting Guides

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Conventional Instrumentation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Signature Cutting Guides n=14 participants at risk Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery. Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.	Conventional Instrumentation n=10 participants at risk Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery. Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.
Nervous system disorders Headache	7.1% 1/14 • Number of events 1 • 6 months	0.00% 0/10 • 6 months

Additional Information

Hillary Overholser

Zimmer Biomet

Phone: 574-933-4180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place