Trial Outcomes & Findings for ASHCOM Shoulder System and Its Related Instruments (NCT NCT04258605)

NCT ID: NCT04258605

Last Updated: 2025-04-03

Results Overview

The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method. Due to early study termination, the survival of the implant was analyzed at 3 years.

• Recruitment status: TERMINATED
• Target enrollment: 24 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2025-04-03

Participant Flow

Unit of analysis: implants

Participant milestones

Measure	ASHCOM Shoulder System Subjects - Uncemented Humeral Stem Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty	ASHCOM Shoulder System Subjects - Fracture Humeral Stem Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty
Overall Study STARTED	22 22	2 2
Overall Study COMPLETED	0 0	0 0
Overall Study NOT COMPLETED	22 22	2 2

Reasons for withdrawal

Measure	ASHCOM Shoulder System Subjects - Uncemented Humeral Stem Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty	ASHCOM Shoulder System Subjects - Fracture Humeral Stem Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty
Overall Study Death	1	0
Overall Study Early study termination	21	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	ASHCOM Shoulder System Subjects - Uncemented Humeral Stem n=22 Participants Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem ASHCOM Shoulder System: Reverse Shoulder Arthroplasty	ASHCOM Shoulder System Subjects - Fracture Humeral Stem n=2 Participants Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem ASHCOM Shoulder System: Reverse Shoulder Arthroplasty	Total n=24 Participants Total of all reporting groups
Age, Continuous	70.14 years STANDARD_DEVIATION 6.14 • n=22 Participants	72.5 years STANDARD_DEVIATION 3.54 • n=2 Participants	70.33 years STANDARD_DEVIATION 5.95 • n=24 Participants
Sex: Female, Male Female	10 Participants n=22 Participants	2 Participants n=2 Participants	12 Participants n=24 Participants
Sex: Female, Male Male	12 Participants n=22 Participants	0 Participants n=2 Participants	12 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Italy	22 participants n=22 Participants	2 participants n=2 Participants	24 participants n=24 Participants
Preop BMI	26.34 kg/m^2 STANDARD_DEVIATION 2.46 • n=22 Participants	22.2 kg/m^2 STANDARD_DEVIATION 1.13 • n=2 Participants	25.99 kg/m^2 STANDARD_DEVIATION 2.64 • n=24 Participants

PRIMARY outcome

Timeframe: 3 years

The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method.

Due to early study termination, the survival of the implant was analyzed at 3 years.

Outcome measures

Measure	ASHCOM Shoulder System Subjects - Uncemented Humeral Stem n=21 Participants Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty	ASHCOM Shoulder System Subjects - Fracture Humeral Stem n=2 Participants Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty
Survival of Implant System (Kaplan Meier)	21 Participants	2 Participants

SECONDARY outcome

Timeframe: Pre-operative (baseline), 1 year, 2 years post-operative

Population: The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit and for one patient the score was not collected at the 2 years follow-up.

The secondary endpoint of this study is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Due to early study termination, the Constant and Murley Score was assessed at 2 years.

The Constant and Murley score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (activities of daily living - sleep, work, recreation/sport; 20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment; 40 points) and strength (25 points), for a total of 65 points. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome).

Outcome measures

Measure	ASHCOM Shoulder System Subjects - Uncemented Humeral Stem n=22 Participants Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty	ASHCOM Shoulder System Subjects - Fracture Humeral Stem n=2 Implants Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty
The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM) Preop	7.91 score on a scale Standard Deviation 8.18	5.0 score on a scale Standard Deviation 7.07
The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM) 1 year	74.0 score on a scale Standard Deviation 12.55	55.0 score on a scale Standard Deviation 4.24
The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM) 2 years	82.95 score on a scale Standard Deviation 8.65	70.5 score on a scale Standard Deviation 9.19

SECONDARY outcome

Timeframe: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative

Population: The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit and for one patient the score was not collected at the 2 years follow-up.

The Oxford Shoulder Score (OSS) is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following total shoulder arthroplasty. The OSS consists of twelve questions covering function and pain associated with the shoulder. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible and a minimum of 0, representing the worst possible.

The outcome score can be categorized as: Satisfactory Joint Function: 40 - 48, Moderate-Mild Arthritis: 30 - 39, Moderate-Severe Arthritis: 20 - 29, Severe Arthritis: 0 - 19.

Outcome measures

Measure	ASHCOM Shoulder System Subjects - Uncemented Humeral Stem n=22 Implants Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty	ASHCOM Shoulder System Subjects - Fracture Humeral Stem n=2 Implants Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty
Oxford Shoulder Score (OSS) Preop	6.27 score on a scale Standard Deviation 3.56	5.5 score on a scale Standard Deviation 7.78
Oxford Shoulder Score (OSS) 3-6 Month	41.81 score on a scale Standard Deviation 3.97	32.5 score on a scale Standard Deviation 0.71
Oxford Shoulder Score (OSS) 1 Year	47.62 score on a scale Standard Deviation 0.92	45.5 score on a scale Standard Deviation 0.71
Oxford Shoulder Score (OSS) 2 Year	47.8 score on a scale Standard Deviation 0.52	48.0 score on a scale Standard Deviation 0.0
Oxford Shoulder Score (OSS) 3 Year	48.0 score on a scale Standard Deviation 0.0	47.5 score on a scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative

Population: The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit and for one patient the score was not collected at the 3-6 months and 1 year follow-up visit.

The EQ-5D-5L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573. It included the Health State, which is a self-reported assessment about the patient's health on that day at a VAS from 0 to 100 with 100 being the best health one can imagine and 0 the worst.

Outcome measures

Measure	ASHCOM Shoulder System Subjects - Uncemented Humeral Stem n=22 Participants Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty	ASHCOM Shoulder System Subjects - Fracture Humeral Stem n=2 Participants Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty
EQ-5D-5L Score 3 Year	1.0 score on a scale Standard Deviation 0.01	0.97 score on a scale Standard Deviation 0.04
EQ-5D-5L Score Preop	0.22 score on a scale Standard Deviation 0.16	0.06 score on a scale Standard Deviation 0.07
EQ-5D-5L Score 3-6 Months	0.79 score on a scale Standard Deviation 0.11	0.56 score on a scale Standard Deviation 0.15
EQ-5D-5L Score 1 Year	0.97 score on a scale Standard Deviation 0.08	0.67 score on a scale Standard Deviation 0.17
EQ-5D-5L Score 2 Year	0.99 score on a scale Standard Deviation 0.05	0.88 score on a scale Standard Deviation 0.0

SECONDARY outcome

Timeframe: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative

Population: The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit. For one patient the score was not collected at the 3-6 months follow-up visit and for two patients at the 1 year follow-up visit.

The Subjective Shoulder Value (SSV) is a single point, subjective estimate of a patient's condition. The patient is asked to rate the functionality of their operated shoulder on a scale of 0% - 100% of normal.

Outcome measures

Measure	ASHCOM Shoulder System Subjects - Uncemented Humeral Stem n=22 Implants Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty	ASHCOM Shoulder System Subjects - Fracture Humeral Stem n=2 Implants Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty
Subjective Shoulder Value (SSV) Preop	25.0 percentage of normal Standard Deviation 14.72	10.0 percentage of normal Standard Deviation 14.14
Subjective Shoulder Value (SSV) 1 Year	89.74 percentage of normal Standard Deviation 9.64	77.5 percentage of normal Standard Deviation 3.54
Subjective Shoulder Value (SSV) 3-6 Months	76.5 percentage of normal Standard Deviation 9.47	62.5 percentage of normal Standard Deviation 3.54
Subjective Shoulder Value (SSV) 2 Year	94.74 percentage of normal Standard Deviation 7.35	90.0 percentage of normal Standard Deviation 0.0
Subjective Shoulder Value (SSV) 3 Year	96.19 percentage of normal Standard Deviation 5.46	97.5 percentage of normal Standard Deviation 3.54

SECONDARY outcome

Timeframe: 2 years post-operative

Population: ASHCOM Shoulder System subjects - Uncemented humeral stem: The number analyzed at 2 years is 21, as one patient passed away prior to the 3-6 month visit.

Radiographic parameters: X-rays have been evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes (glenoid), component migration (humeral stem subsidence / glenoid component migration), heterotopic ossification and scapular notching

Outcome measures

Measure	ASHCOM Shoulder System Subjects - Uncemented Humeral Stem n=21 Participants Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty	ASHCOM Shoulder System Subjects - Fracture Humeral Stem n=2 Participants Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty
Radiographic Parameters Any radiographic findings - Yes:	0 Participants	0 Participants
Radiographic Parameters Any radiographic findings - No:	21 Participants	2 Participants

Adverse Events

ASHCOM Shoulder System Subjects - Uncemented Humeral Stem

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

ASHCOM Shoulder System Subjects - Fracture Humeral Stem

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	ASHCOM Shoulder System Subjects - Uncemented Humeral Stem n=22 participants at risk Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty	ASHCOM Shoulder System Subjects - Fracture Humeral Stem n=2 participants at risk Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty
General disorders Not study related death	4.5% 1/22 • Number of events 1 • AEs were collected from the time of surgery until study termination (up to 3 years)	0.00% 0/2 • AEs were collected from the time of surgery until study termination (up to 3 years)

Other adverse events

Adverse event data not reported

Additional Information

Carina Hafner

Zimmer Biomet

Phone: +41797073093

Email: carina.hafner@zimmerbiomet.com

Results disclosure agreements

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

Restriction type: LTE60