NCT05357664: PIN DM

PINNACLE® DM RSA Study

Terminated NA Results posted Last updated 18 April 2024

What this trial tests

NA trial testing Total Hip Arthroplasty in Osteoarthritis in 11 participants. Terminated before completion.

Timeline

6 October 2022

Primary endpoint
20 December 2022

9 February 2023

Quick facts

Lead sponsor	DePuy Orthopaedics
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	6 October 2022
Primary completion	20 December 2022
Estimated completion	9 February 2023
Sites	3 locations across Canada

Drugs / interventions tested

• Total Hip Arthroplasty
• Revision Total Hip Arthroplasty

Conditions studied

• Osteoarthritis — all drugs for Osteoarthritis →
• Degenerative Arthritis — all drugs for Degenerative Arthritis →
• Revision Arthroplasty — all drugs for Revision Arthroplasty →

Sponsor

DePuy Orthopaedics — full company profile →

Who can join

21 and older, any sex, with Osteoarthritis or Degenerative Arthritis. 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.

Harris Hip Score Secondary · 6 weeks post operative

The Harris Hip Score (HHS) has 10 items with four subscales comprising a minimum of 0 points and a maximum of 100 points with higher scores representing better function and outcomes. The four subscales include: pain severity, activities of daily living, absence of deformity and range of motion. Scoring is done according to the following: 90-100 = excellent, 80-89 = good, 70-79 = fair, 60-69 = poor, and below 60 is a failed result

Group	Value	95% CI
Harris Hip Score	79.7	± 9.63

HOOS Jr Score Secondary · 6 weeks

Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) assesses patient pain (2 items), and functions of daily living (4 items). Scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating perfect hip health. This is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty

Group	Value	95% CI
Superior Acetabular Cup Migration	75.3	± 10.29

FJS-12 Secondary · 6 weeks

The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities which suggests a better outcome

Group	Value	95% CI
Forgotten Joint Score (FJS-12)	44.4	± 26

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected up to the six-week time point. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PINNACLE Dual Mobility System

Serious: 1/11 (9%)

Deaths: 0/11

Serious adverse events (1 terms)

Reaction	System	PINNACLE Dual Mobility Sys…
Hypoxia	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	PINNACLE Dual Mobility Sys…
Avulsion fracture	Injury, poisoning and procedural complications	—
Femur fracture	Injury, poisoning and procedural complications	—

Most-reported serious reactions: Hypoxia.

Data from ClinicalTrials.gov NCT05357664 adverse events section.

Sponsor's own description

The primary objective is to establish the mean superior cup migration of the PINNACLE® Dual Mobility Construct using model-based RSA over the first two years post-implantation. The primary endpoint is the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as measured with RSA. Additionally, the data from this study will be compared to historical PINNACLE® data obtained in study DSJ\_2018\_02.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.