Trial Outcomes & Findings for PINNACLE® DM RSA Study (NCT NCT05357664)

Results Overview

Radiostereometric analysis (RSA) measured mean superior cup migration (Y translation in MM)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

2 years

Results posted on

2024-04-18

Participant Flow

Patients were selected for recruitment into the study from the general diagnosis populations defined as "primary total hip arthroplasty" (THA) and "revision total hip arthroplasty" (RTHA). The investigation was conducted at two centers.

Unit of analysis: Hips

Participant milestones

Participant milestones
Measure	PINNACLE Dual Mobility System PINNACLE® Acetabular Cup, PINNACLE® CoCrMo Dual Mobility Metal Liner, a BI-MENTUM™ ALTRX® Dual Mobility Polyethylene Liner, a DePuy femoral stem with a polished femoral neck and a DePuy modular, femoral head PINNACLE® Dual Mobility Metal Liners and Porous-coated PINNACLE® Acetabular Cups are intended for cementless applications.
Overall Study STARTED	11 11
Overall Study COMPLETED	0 0
Overall Study NOT COMPLETED	11 11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A measurement was missed for one participant and BMI could not be calculated

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PINNACLE Dual Mobility System n=11 Hips PINNACLE® Acetabular Cup, PINNACLE® CoCrMo Dual Mobility Metal Liner, a BI-MENTUM™ ALTRX® Dual Mobility Polyethylene Liner, a DePuy femoral stem with a polished femoral neck and a DePuy modular, femoral head PINNACLE® Dual Mobility Metal Liners and Porous-coated PINNACLE® Acetabular Cups are intended for cementless applications.
Age, Continuous	71.1 Years STANDARD_DEVIATION 8.26 • n=11 Participants
Sex: Female, Male Female	6 Participants n=11 Participants
Sex: Female, Male Male	5 Participants n=11 Participants
Body Mass Index (BMI)	29.4 kg/m2 STANDARD_DEVIATION 6.5 • n=10 Participants • A measurement was missed for one participant and BMI could not be calculated

PRIMARY outcome

Timeframe: 2 years

Population: Study subjects who reach two years follow-up will undergo radiostereometric analysis of the study hip to determine if the acetabular cup has migrated from its post-operative position. Please note: data is not reported because the study was terminated at 6 weeks, therefore 2-year radiostereometric analyses could not be performed.

Radiostereometric analysis (RSA) measured mean superior cup migration (Y translation in MM)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks post operative

Population: All study subjects who received a PINNACLE Dual Mobility implant will have their operative hip assessed

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

Outcome measures

Outcome measures
Measure	Superior Acetabular Cup Migration n=10 Hips RSA measured mean superior cup migration (subsidence: Y translation in mm) at 2 years
Harris Hip Score	79.7 units on a scale Standard Deviation 9.63

SECONDARY outcome

Timeframe: 6 weeks

Population: All study subjects who received a PINNACLE Dual Mobility implant were evaluated using the HOOS Jr

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

Outcome measures

Outcome measures
Measure	Superior Acetabular Cup Migration n=10 Hip RSA measured mean superior cup migration (subsidence: Y translation in mm) at 2 years
HOOS Jr Score	75.3 Units on a scale Standard Deviation 10.29

SECONDARY outcome

Timeframe: 6 weeks

Population: All study subjects who received a PINNACLE Dual Mobility Implant were evaluated using the FJS-12

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

Outcome measures

Outcome measures
Measure	Superior Acetabular Cup Migration n=10 Hip RSA measured mean superior cup migration (subsidence: Y translation in mm) at 2 years
FJS-12	44.4 Units on a scale Standard Deviation 26

SECONDARY outcome

Timeframe: 6 weeks, 1 year, 2 years

Population: Study subjects who received a Pinnacle Dual Mobility implant will have linear head penetration measured at specified timepoints. Please note: data is not reported because radiostereometric analyses were scheduled to be performed once all subjects had completed their visit at each interval. Since only 11 subjects were enrolled, no RSA measurements were performed prior to study closure at 6-weeks.

Femoral head penetration into the polyethylene liner component will be determined and measured radiographically

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months, 6 months and 1 year

Population: Study subjects who received a PINNACLE Dual Mobility implant. Please note: data is not reported because radiostereometric analyses were scheduled to be performed once all subjects had completed their visit at each interval. Since only 11 subjects were enrolled, no RSA measurements were performed prior to study closure at 6-weeks.

Superior migration of the acetabular cup will be measured using RSA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks, 3 months, 6 months, 1 year and 2 years

Population: Study subjects who received a PINNACLE Dual Mobility implant. Please note: data is not reported because radiostereometric analyses were scheduled to be performed once all subjects had completed their visit at each interval. Since only 11 subjects were enrolled, no RSA measurements were performed prior to study closure at 6-weeks.

Additional RSA measurements (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points

Outcome measures

Outcome data not reported

Adverse Events

PINNACLE Dual Mobility System

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PINNACLE Dual Mobility System n=11 participants at risk PINNACLE® Acetabular Cup, PINNACLE® CoCrMo Dual Mobility Metal Liner, a BI-MENTUM™ ALTRX® Dual Mobility Polyethylene Liner, a DePuy femoral stem with a polished femoral neck and a DePuy modular, femoral head PINNACLE® Dual Mobility Metal Liners and Porous-coated PINNACLE® Acetabular Cups are intended for cementless applications.
Respiratory, thoracic and mediastinal disorders Hypoxia	9.1% 1/11 • Number of events 1 • Adverse events were collected up to the six-week time point

Other adverse events

Other adverse events
Measure	PINNACLE Dual Mobility System n=11 participants at risk PINNACLE® Acetabular Cup, PINNACLE® CoCrMo Dual Mobility Metal Liner, a BI-MENTUM™ ALTRX® Dual Mobility Polyethylene Liner, a DePuy femoral stem with a polished femoral neck and a DePuy modular, femoral head PINNACLE® Dual Mobility Metal Liners and Porous-coated PINNACLE® Acetabular Cups are intended for cementless applications.
Injury, poisoning and procedural complications Avulsion fracture	9.1% 1/11 • Number of events 1 • Adverse events were collected up to the six-week time point
Injury, poisoning and procedural complications Femur fracture	9.1% 1/11 • Number of events 1 • Adverse events were collected up to the six-week time point

Additional Information

Dave Whalen

DePuy Synthes

Phone: 574-404-9399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Publication restrictions are in place

Restriction type: OTHER