Trial Outcomes & Findings for PMCF Study on the Safety and Performance of the Alloclassic Variall Cup Ceramic Bearing System in Total Hip Arthroplasty (NCT NCT03672370)

Results Overview

The Harris Hip Score (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 points and a maximum of 100 points. Clinical success will be defined as a modified Harris Hip score of \> 80 that included a rating of 'mild', or 'no pain'; a failure will be defined as a modified Harris Hip score \< 80.

Recruitment status

TERMINATED

Target enrollment

100 participants

Primary outcome timeframe

3 years

Results posted on

2021-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	Alloclassic Variall Cup Subjects who received the Alloclassic Variall Cup Ceramic Bearing System
Overall Study STARTED	89
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alloclassic Variall Cup n=89 Participants Subjects who received the Alloclassic Variall Cup Ceramic Bearing System
Age, Continuous	63.9 years STANDARD_DEVIATION 9.0 • n=89 Participants
Sex: Female, Male Female	51 Participants n=89 Participants
Sex: Female, Male Male	38 Participants n=89 Participants
Region of Enrollment Austria	89 participants n=89 Participants
BMI	29.0 kg/m^2 STANDARD_DEVIATION 1.2 • n=89 Participants

PRIMARY outcome

Timeframe: 3 years

The Harris Hip Score (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 points and a maximum of 100 points. Clinical success will be defined as a modified Harris Hip score of \> 80 that included a rating of 'mild', or 'no pain'; a failure will be defined as a modified Harris Hip score \< 80.

Outcome measures

Outcome measures
Measure	Alloclassic Variall Cup n=42 Participants Subjects who received the Alloclassic Variall Cup Ceramic Bearing System
Clinical Success Will be Based on the Harris Hip Scoring System	92.6 score on a scale Standard Deviation 8.9

PRIMARY outcome

Timeframe: 4 years

Endpoint revision of any investigational device for any reason attributable to any investigational device

Outcome measures

Outcome measures
Measure	Alloclassic Variall Cup n=89 Participants Subjects who received the Alloclassic Variall Cup Ceramic Bearing System
Percentage of Participants Who Survived According to the Survival Analysis With the Kaplan Meier (K-M) Estimate	98.63 percentage of participants Interval 90.67 to 99.81

SECONDARY outcome

Timeframe: 3 years

The purpose of the Oxford Hip Score (OHS) is to assess the outcome after total hip arthroplasty by measuring cases' perceptions in adjunction to surgery. The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score

Outcome measures

Outcome measures
Measure	Alloclassic Variall Cup n=42 Participants Subjects who received the Alloclassic Variall Cup Ceramic Bearing System
Oxford Hip Score	44.7 score on a scale Standard Deviation 7.9

SECONDARY outcome

Timeframe: 3 years

The EQ-5D questionnaire comprises two parts. For the first part, respondents are asked to tick boxes to indicate the level of problem on each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). In total, there are three levels per dimension (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Responses are coded as single-digit numbers expressing the severity level selected in each dimension. The digits for the five dimensions are combined in a 5-digit code. The second part of the questionnaire is the EQ Visual Analogue Scale. This captures the respondent's overall assessment of their health from 0 (worst health imaginable) to 100 (best health imaginable). The results from both parts are indexed, weightened and pulled together. The final score lies between 1 for full health and 0 for death. Values less than 0 are possible considered to be worse than death.

Outcome measures

Outcome measures
Measure	Alloclassic Variall Cup n=42 Participants Subjects who received the Alloclassic Variall Cup Ceramic Bearing System
EQ-5D	0.9 score on a scale Standard Deviation 0.2

Adverse Events

Alloclassic Variall Cup

Serious events: 7 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Alloclassic Variall Cup n=89 participants at risk Subjects who received the Alloclassic Variall Cup Ceramic Bearing System
Infections and infestations Infection, revision required	2.2% 2/89 • 3 years
Musculoskeletal and connective tissue disorders Periprosthetic fractures, revision required	2.2% 2/89 • 3 years
Respiratory, thoracic and mediastinal disorders Lung cancer, unknown treatment	1.1% 1/89 • 3 years
Musculoskeletal and connective tissue disorders Traumatic event at outpatient rehab, surgical fragment fixation	1.1% 1/89 • 3 years
Vascular disorders Death, unknown reason, no relation to device	1.1% 1/89 • 3 years

Other adverse events

Other adverse events
Measure	Alloclassic Variall Cup n=89 participants at risk Subjects who received the Alloclassic Variall Cup Ceramic Bearing System
Musculoskeletal and connective tissue disorders femoral implant loosening	1.1% 1/89 • 3 years
Musculoskeletal and connective tissue disorders Pain in hip when sitting down, radiating to the knee	1.1% 1/89 • 3 years

Additional Information

Clinical Project Lead, Sandra Rosser

Zimmer Biomet

Phone: +41 (0)58 854 84 09

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60