Trial Outcomes & Findings for Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty (NCT NCT03672916)
NCT ID: NCT03672916
Last Updated: 2025-02-12
Results Overview
The objective of this study is implant survival at 10 years which is assessed by revision of the the study device calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component.
COMPLETED
185 participants
10 years post-surgery
2025-02-12
Participant Flow
Participant milestones
| Measure |
Patients Who Received the Allofit IT With BIOLOX Delta
Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners
|
|---|---|
|
Overall Study
STARTED
|
185
|
|
Overall Study
COMPLETED
|
133
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
Patients Who Received the Allofit IT With BIOLOX Delta
Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners
|
|---|---|
|
Overall Study
Death
|
6
|
|
Overall Study
Lost to Follow-up
|
29
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
11
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients Who Received the Allofit IT With BIOLOX Delta
n=184 Participants
Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners
|
|---|---|
|
Age, Continuous
|
56.4 Age (years) at date of surgery
STANDARD_DEVIATION 9 • n=184 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=184 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=184 Participants
|
|
Region of Enrollment
Sweden
|
48 participants
n=184 Participants
|
|
Region of Enrollment
Germany
|
136 participants
n=184 Participants
|
PRIMARY outcome
Timeframe: 10 years post-surgeryPopulation: All study patients
The objective of this study is implant survival at 10 years which is assessed by revision of the the study device calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component.
Outcome measures
| Measure |
Patients Who Received the Allofit IT With BIOLOX Delta
n=185 Participants
Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners
|
|---|---|
|
Survivorship
|
179 Implants
|
PRIMARY outcome
Timeframe: Up to 10 years postoperativePopulation: The count of all participants with adverse events is summarized. Details are available in the Adverse Event overview of the results section
Will be evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) b) Efficacy:
Outcome measures
| Measure |
Patients Who Received the Allofit IT With BIOLOX Delta
n=185 Participants
Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners
|
|---|---|
|
Safety of the Implant
Hip Related complications (AE and SAE)
|
9 Participants
|
|
Safety of the Implant
Revisions
|
6 Participants
|
|
Safety of the Implant
SAE's not related to study hip
|
38 Participants
|
SECONDARY outcome
Timeframe: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 YearPopulation: All study patients
The Harris Hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70
Outcome measures
| Measure |
Patients Who Received the Allofit IT With BIOLOX Delta
n=185 Participants
Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners
|
|---|---|
|
Harris Hip Score
2 Year
|
96.9 score on a scale
Standard Deviation 6.9
|
|
Harris Hip Score
3 Year
|
96.1 score on a scale
Standard Deviation 9
|
|
Harris Hip Score
5 Year
|
95.2 score on a scale
Standard Deviation 9.5
|
|
Harris Hip Score
7 Year
|
96.0 score on a scale
Standard Deviation 8.3
|
|
Harris Hip Score
10 Year
|
93.9 score on a scale
Standard Deviation 11.3
|
|
Harris Hip Score
Pre-op
|
48.8 score on a scale
Standard Deviation 11.5
|
|
Harris Hip Score
6 months
|
93.2 score on a scale
Standard Deviation 11.3
|
|
Harris Hip Score
1 Year
|
96.1 score on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 YearPopulation: The number of participants decreased over time, reasons are: questionnaire not completed in full (score calculation not possible), missed visits, lost to follow-up or withdrawn from the study.
The EQ-5D-3L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life. The questionnaire includes five dimensions referring to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in three ways/levels indicating no problems, some problems, and extreme problems. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.594; negative numbers correspond to a self-assessed health state worse than being dead.
Outcome measures
| Measure |
Patients Who Received the Allofit IT With BIOLOX Delta
n=184 Participants
Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners
|
|---|---|
|
EQ-5D
pre-op
|
0.4 score on a scale
Standard Deviation 0.3
|
|
EQ-5D
6 months
|
0.9 score on a scale
Standard Deviation 0.2
|
|
EQ-5D
1 Year
|
0.9 score on a scale
Standard Deviation 0.2
|
|
EQ-5D
2 Year
|
0.9 score on a scale
Standard Deviation 0.2
|
|
EQ-5D
7 Year
|
0.8 score on a scale
Standard Deviation 0.2
|
|
EQ-5D
10 Year
|
0.8 score on a scale
Standard Deviation 0.2
|
|
EQ-5D
3 Year
|
0.9 score on a scale
Standard Deviation 0.2
|
|
EQ-5D
5 Year
|
0.8 score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 YearPopulation: All study patients
The SF-12 is a multipurpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning and lower scores indicating worse physical and mental health functioning.
Outcome measures
| Measure |
Patients Who Received the Allofit IT With BIOLOX Delta
n=185 Participants
Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners
|
|---|---|
|
SF-12 Physical and Mental Functional Scores
Pre-op, SF12 Physical
|
28.8 score on a scale
Standard Deviation 7.1
|
|
SF-12 Physical and Mental Functional Scores
1 Year, SF12 Physical
|
48.5 score on a scale
Standard Deviation 8.9
|
|
SF-12 Physical and Mental Functional Scores
2 Year, SF12 Physical
|
49.5 score on a scale
Standard Deviation 9.3
|
|
SF-12 Physical and Mental Functional Scores
5 Year, SF12 Physical
|
46.9 score on a scale
Standard Deviation 9.8
|
|
SF-12 Physical and Mental Functional Scores
Pre-op, SF12 Mental
|
44.9 score on a scale
Standard Deviation 11.8
|
|
SF-12 Physical and Mental Functional Scores
2 Year, SF12 Mental
|
55.6 score on a scale
Standard Deviation 7.2
|
|
SF-12 Physical and Mental Functional Scores
7 Year, SF12 Mental
|
52.5 score on a scale
Standard Deviation 10.4
|
|
SF-12 Physical and Mental Functional Scores
6 months, SF12 Physical
|
46.5 score on a scale
Standard Deviation 9.9
|
|
SF-12 Physical and Mental Functional Scores
3 Year, SF12 Physical
|
47.0 score on a scale
Standard Deviation 10.6
|
|
SF-12 Physical and Mental Functional Scores
7 Year, SF12 Physical
|
47.2 score on a scale
Standard Deviation 10.8
|
|
SF-12 Physical and Mental Functional Scores
10 Year, SF12 Physical
|
47.3 score on a scale
Standard Deviation 9.9
|
|
SF-12 Physical and Mental Functional Scores
6 months, SF12 Mental
|
55.7 score on a scale
Standard Deviation 7.9
|
|
SF-12 Physical and Mental Functional Scores
1 Year, SF12 Mental
|
55.0 score on a scale
Standard Deviation 7.8
|
|
SF-12 Physical and Mental Functional Scores
3 Year, SF12 Mental
|
54.6 score on a scale
Standard Deviation 8.4
|
|
SF-12 Physical and Mental Functional Scores
5 Year, SF12 Mental
|
54.1 score on a scale
Standard Deviation 9.1
|
|
SF-12 Physical and Mental Functional Scores
10 Year, SF12 Mental
|
54.2 score on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 YearPopulation: The number of participants decreased over time, reasons are: questionnaire not completed, missed visits, lost to follow-up or withdrawn from the study.
The case administered University of California at Los Angeles (UCLA) score allows assessment of the case's activity level at each time point with scores from 1 (Wholly inactive: dependent on others; cannot leave residence) to 10 (Regularly participates in impact sports)
Outcome measures
| Measure |
Patients Who Received the Allofit IT With BIOLOX Delta
n=185 Participants
Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners
|
|---|---|
|
UCLA Activity Score
3 Year
|
6.2 score on a scale
Standard Deviation 1.7
|
|
UCLA Activity Score
5 Year
|
6.4 score on a scale
Standard Deviation 1.7
|
|
UCLA Activity Score
7 Year
|
6.0 score on a scale
Standard Deviation 1.9
|
|
UCLA Activity Score
10 Year
|
6.4 score on a scale
Standard Deviation 1.7
|
|
UCLA Activity Score
Pre-op
|
4.3 score on a scale
Standard Deviation 1.6
|
|
UCLA Activity Score
6 months
|
6.1 score on a scale
Standard Deviation 1.7
|
|
UCLA Activity Score
1 Year
|
6.4 score on a scale
Standard Deviation 1.5
|
|
UCLA Activity Score
2 Year
|
6.6 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 10 Years post-surgeryPopulation: All study patients
Radiographic evaluation was done to assess (radiolucency, osteolysis, subsidence, cup migration, change in cup angle and change in femoral shaft angle) of study subjects who received the Allofit IT Acetabular System
Outcome measures
| Measure |
Patients Who Received the Allofit IT With BIOLOX Delta
n=185 Participants
Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners
|
|---|---|
|
Radiographic Evaluations
Stem Subsidence (0.2mm - 6mm)
|
11 Participants
|
|
Radiographic Evaluations
Radiolucency (>2mm)
|
4 Participants
|
|
Radiographic Evaluations
Heterotopic Ossification (Class III and class IV)
|
3 Participants
|
|
Radiographic Evaluations
Calcar Resorption (0.3mm - 5mm)
|
9 Participants
|
|
Radiographic Evaluations
Cup Migration (0.3mm - 0.9mm)
|
6 Participants
|
|
Radiographic Evaluations
Osteolysis
|
1 Participants
|
Adverse Events
Patients Who Received the Allofit IT With BIOLOX Delta
Serious adverse events
| Measure |
Patients Who Received the Allofit IT With BIOLOX Delta
n=185 participants at risk
Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners
|
|---|---|
|
Surgical and medical procedures
Study-hip affected: Revisions of implant system
|
3.2%
6/185 • Number of events 6 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Surgical and medical procedures
Study-hip affected: Luxation/Dislocation
|
1.1%
2/185 • Number of events 3 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Injury, poisoning and procedural complications
Study-hip affected: Periprosthetic femur fracture
|
0.54%
1/185 • Number of events 1 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal (non-study hip)
|
11.9%
22/185 • Number of events 26 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Cardiac disorders
Cardiovascular
|
5.4%
10/185 • Number of events 10 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncological
|
3.8%
7/185 • Number of events 7 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Infections and infestations
Infection (non-study hip)
|
1.1%
2/185 • Number of events 2 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Nervous system disorders
Neurological
|
1.1%
2/185 • Number of events 2 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Respiratory
|
0.54%
1/185 • Number of events 2 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
General disorders
Reported deaths with unknown causes
|
1.6%
3/185 • Number of events 3 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
Other adverse events
| Measure |
Patients Who Received the Allofit IT With BIOLOX Delta
n=185 participants at risk
Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Study-hip affected adverse events
|
3.2%
6/185 • Number of events 6 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal (non-study hip)
|
15.1%
28/185 • Number of events 36 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Cardiac disorders
Cardiovascular
|
5.9%
11/185 • Number of events 11 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncological
|
2.2%
4/185 • Number of events 4 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Infections and infestations
Infection
|
1.6%
3/185 • Number of events 3 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Endocrine disorders
Endocrine
|
1.6%
3/185 • Number of events 3 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
Nervous system disorders
Neurological
|
1.1%
2/185 • Number of events 2 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
|
General disorders
Others
|
2.7%
5/185 • Number of events 5 • From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable
|
Additional Information
Martina Hersberger, Clinical Project Lead
Zimmer Biomet
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place