Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, single centre, randomized clinical study; series of patients with a 5-years patient evaluation period.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trident cup, X3 inserts, 28 mm head | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trident cup, X3 inserts, 28 mm head | Device | Orthopaedic implant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks, 3 months, 1, 2 and 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ide C. Heyligers, MD | Atrium Medical Center, Heerlen, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Medical Center | Heerlen | Netherlands |
40 participants/hips - 6 participants/hips excluded during surgery = 34 participants/hips
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Wear data were not measured at the investigation site. | Posted | 5 years follow-up |
|
Up to 5 years post-operative
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Luxation of hip prosthesis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug McGurty | Stryker EU Operations B.V. Herikerbergweg 110 1101 CM Amsterdam The Netherlands | +44 (0) 1635 500690 | doug.mcgurty@stryker.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| Trident cup, X3 inserts, 40 mm head |
| Device |
Orthopaedic implant |
|
| Symax stem | Device | Orthopaedic implant |
|
| Accolade TMZF stem | Device | Orthopaedic implant |
|
| 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. |
| 6 weeks, 3 months, 1, 2 and 5 years |
| Death |
|
| Site terminated |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Data not available for all participants | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 |
|
| 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. | Participants with available data. Overall number of participants analysed is based upon the 6 week population. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks, 3 months, 1, 2 and 5 years |
|
|
|
| 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. | Merle D'Aubergine Score (MdA) data were not measured at the investigation site. | Posted | 6 weeks, 3 months, 1, 2 and 5 years |
|
|
| 6 |
| 16 |
| 0 |
| 16 |
| EG001 | 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 | 2 | 18 | 0 | 18 |
| Bladder Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Bowel Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Cardiac Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Intraoperative Trochanter Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lung carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Superficial infection | Infections and infestations | Non-systematic Assessment |
|
Not provided
| 3 months HHS |
|
|
| 1 year HHS |
|
|
| 2 years HHS |
|
|
| 5 years HHS |
|
|