Arthroplasty, Replacement, Hip
Conditions
Brief summary
Prospective, single centre, randomized clinical study; series of patients with a 5-years patient evaluation period.
Detailed description
This is a single centre randomized clinical outcomes study. The Symax stem or Accolade TMZF (Titan, Molybdenum, Zirconium, Ferrum) in combination with the Hemispherical Trident cup, X3 inserts, 28 and 40 mm Metal heads are the primary components to be implanted for evaluation.
Interventions
DEVICETrident cup, X3 inserts, 28 mm head
Orthopaedic implant
DEVICETrident cup, X3 inserts, 40 mm head
Orthopaedic implant
DEVICESymax stem
Orthopaedic implant
DEVICEAccolade TMZF stem
Orthopaedic implant
Sponsors
Stryker Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male and non pregnant female patients between 18-75 years of age. 2. Patients requiring uncemented primary total hip arthroplasty (THA), suitable for the use of the Symax stem 3. Patients with a diagnosis of osteoarthritis (OA), rheumatoid arthritis (RA), avascular necrosis (AVN) or post-traumatic arthritis (TA). 4. Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation 5. Patients who signed the specific Informed Consent Form prior to surgery
Exclusion criteria
1. Patients who require revision of a previously implanted THA 2. Patients who had a THA on contra-lateral side within the last 1 year. 3. Patients who had a THA on contralateral side more than 1 year ago and the rehabilitation period outcome was considered unsatisfactory or not good. (Patients with contra-lateral THA \> 1 year ago with good outcome (Harris Hip Score \> 85) can be included in the study). 4. Patients who will need lower limb joint replacement for another joint within one year. 5. Bilaterally operated patient. 6. Patients who have had a prior procedure of acetabular osteotomy. 7. Patients with active or suspected infection. 8. Patients with malignancy - active malignancy 9. Patients with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e. severe osteoporosis, Paget's disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. 10. The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period. 11. Female patients planning a pregnancy during the course of the study. 12. Patients with systemic or metabolic disorders leading to progressive bone deterioration. 13. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule. 14. Patients with other severe concurrent joint involvements which can affect their outcome. 15. Patients with other concurrent illnesses which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus, psoriasis, Insulin dependent Type I diabetes or renal disease requiring dialysis. 16. Surgeries to be performed with navigation and/or robot-assisted instruments. 17. Patient with a known sensitivity to device materials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Compare Wear of the Polyethylene X3 Insert Based on Digital Radiographs Using the Hip Analysis Suite (HAS). | 5 years follow-up | Determine equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes using HAS, a software for the determination of polyethylene wear on digital radiographs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score (HHS) Patient Questionnaire | 6 weeks, 3 months, 1, 2 and 5 years | Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor. |
| Merle D'Aubergine Score (MdA) | 6 weeks, 3 months, 1, 2 and 5 years | The Merle D'Aubergine-Charnley Score is a simplified clinical scoring system for the hip. The overall score is determined by the sum of scores obtained from each dimension of pain, walking ability and joint mobility. The overall numeric score is given by adding the domain scores. Clinical grades: Excellent, 18, Good 15-17, Fair 13-14, Poor \<13. |
Countries
Netherlands
Participant flow
Pre-assignment details
40 participants/hips - 6 participants/hips excluded during surgery = 34 participants/hips
Participants by arm
| Arm | Count |
|---|---|
| Trident Cup, X3 Inserts, 28 mm Head Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.
Trident cup, X3 inserts, 28 mm head: Orthopaedic implant
Symax stem: Orthopaedic implant
Accolade TMZF stem: Orthopaedic implant | 16 |
| Trident Cup, X3 Inserts, 40 mm Head Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes. Trident cup in combination with Symax stem or Accolade TMZF stem.
Trident cup, X3 inserts, 40 mm head: Orthopaedic implant
Symax stem: Orthopaedic implant
Accolade TMZF stem: Orthopaedic implant | 18 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Revision | 1 | 1 |
| Overall Study | Site terminated | 11 | 10 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Trident Cup, X3 Inserts, 28 mm Head | Trident Cup, X3 Inserts, 40 mm Head | Total |
|---|---|---|---|
| Age, Continuous | 66.67 years STANDARD_DEVIATION 4.68 | 62.91 years STANDARD_DEVIATION 6.25 | 64.68 years STANDARD_DEVIATION 5.87 |
| Region of Enrollment Netherlands | 16 participants | 18 participants | 34 participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 18 |
| serious Total, serious adverse events | 6 / 16 | 2 / 18 |
Outcome results
Primary
To Compare Wear of the Polyethylene X3 Insert Based on Digital Radiographs Using the Hip Analysis Suite (HAS).
Determine equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes using HAS, a software for the determination of polyethylene wear on digital radiographs.
Time frame: 5 years follow-up
Population: Wear data were not measured at the investigation site.
Secondary
Harris Hip Score (HHS) Patient Questionnaire
Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor.
Time frame: 6 weeks, 3 months, 1, 2 and 5 years
Population: Participants with available data. Overall number of participants analysed is based upon the 6 week population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trident Cup, X3 Inserts, 28 mm Head | Harris Hip Score (HHS) Patient Questionnaire | 3 months HHS | 87.06 units on a scale | Standard Deviation 12.03 |
| Trident Cup, X3 Inserts, 28 mm Head | Harris Hip Score (HHS) Patient Questionnaire | 2 years HHS | 90.48 units on a scale | Standard Deviation 6.05 |
| Trident Cup, X3 Inserts, 28 mm Head | Harris Hip Score (HHS) Patient Questionnaire | 1 year HHS | 91.71 units on a scale | Standard Deviation 6.14 |
| Trident Cup, X3 Inserts, 28 mm Head | Harris Hip Score (HHS) Patient Questionnaire | 5 years HHS | 92.36 units on a scale | Standard Deviation 6.56 |
| Trident Cup, X3 Inserts, 28 mm Head | Harris Hip Score (HHS) Patient Questionnaire | 6 weeks HHS | 82.89 units on a scale | Standard Deviation 11.38 |
| Trident Cup, X3 Inserts, 40 mm Head | Harris Hip Score (HHS) Patient Questionnaire | 5 years HHS | 85.95 units on a scale | Standard Deviation 21.43 |
| Trident Cup, X3 Inserts, 40 mm Head | Harris Hip Score (HHS) Patient Questionnaire | 6 weeks HHS | 85.73 units on a scale | Standard Deviation 7.91 |
| Trident Cup, X3 Inserts, 40 mm Head | Harris Hip Score (HHS) Patient Questionnaire | 3 months HHS | 92.60 units on a scale | Standard Deviation 4.08 |
| Trident Cup, X3 Inserts, 40 mm Head | Harris Hip Score (HHS) Patient Questionnaire | 1 year HHS | 92.76 units on a scale | Standard Deviation 4.3 |
| Trident Cup, X3 Inserts, 40 mm Head | Harris Hip Score (HHS) Patient Questionnaire | 2 years HHS | 92.63 units on a scale | Standard Deviation 6.81 |
Secondary
Merle D'Aubergine Score (MdA)
The Merle D'Aubergine-Charnley Score is a simplified clinical scoring system for the hip. The overall score is determined by the sum of scores obtained from each dimension of pain, walking ability and joint mobility. The overall numeric score is given by adding the domain scores. Clinical grades: Excellent, 18, Good 15-17, Fair 13-14, Poor \<13.
Time frame: 6 weeks, 3 months, 1, 2 and 5 years
Population: Merle D'Aubergine Score (MdA) data were not measured at the investigation site.