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A Post-market Clinical Follow-up Study to provide safety, performance and clinical benefits data on the Exceed ABT acetabular cup (implants and instruments) when used in combination with ceramic liners or polyethylene articulating liners bearing Options.
A single-center, cohort observational clinical outcomes study
Study Aim: To collect survivorship and clinical outcomes long-term data confirm-ing safety, performance and clinical benefits of the Exceed ABT ce-mentless cup when used in combination with ceramic and polyeth-ylene articulating liners
Objectives: Primary Objectives:
Clinical performance - as measured by clinical score data (HHS, WOMAC and Oxford Hip Score), radiographic as-sessments and survivorship which will be based on removal of the device.
Secondary Objectives:
Safety will be evaluated by monitoring incidence of adverse events. Length of study: 13 years (3 years enrollment plus 10 years follow-up): Post-operative follow-up visits at: 1, 3, 5, 7 and 10 years
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| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score | Clinical performance - as measured by clinical score data (HHS). The 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 and a maximum of 100 points. The scale: Excellent:90 - 100, Good: 80 - 89, Fair: 70 - 79, Poor: < 70. | 10 years |
| Western Ontario and McMasters Universities Osteoarthritis Index-WOMAC Pain Score | Clinical performance - as measured by clinical score data - womac pain The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. A higher score indicates a worse clinical outcome. Womac pain score is reported here. | 10 years |
| 10 Year Survivorship | Calculated Kaplan-Meier Survivorship based on revision of any component for any reason. Presented as the % of participants with the implant still in place 10 years post-operative. | 10 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Hip Score | The Oxford hip score (OHS) is self-completion patient-centered outcome measure tool designed to assess disability in patients undergoing total hip replacement. The OHS consists of 12 questions about pain and disability experienced over the past four weeks. Each item has five response categories, given a score of between 1-5 (low disability to high disability). Scoring involves summating the total for each item to produce a final score between 12-60, with a higher score indicating greater disability (old Oxford score). |
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Inclusion Criteria:
Exclusion Criteria:
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Male and Female ≥18 years
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A MoP | Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly) |
| FG001 | Group B CoC | Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A MoP | Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly) |
| BG001 | Group B CoC | Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic) |
| 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 | Harris Hip Score | Clinical performance - as measured by clinical score data (HHS). The 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 and a maximum of 100 points. The scale: Excellent:90 - 100, Good: 80 - 89, Fair: 70 - 79, Poor: < 70. | Posted | Mean | Standard Deviation | score on a scale | 10 years |
|
All adverse events up to 10 years post-op
Definitions according to ISO14155:2013
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A MoP | Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | Death (any cause, not related to procedure/implant) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in left lateral thigh after fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Initial CRF in the study did not record if an adverse event was serious yes/no. Where unknown, the event is recorded as serious.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Meijer | Zimmer Biomet | +31627933741 | linda.meijer@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2018 | Feb 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 10 years |
| Withdrawal by Subject |
|
| Screen Failure/Not treated |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Operative Side | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
|
|
| Primary | Western Ontario and McMasters Universities Osteoarthritis Index-WOMAC Pain Score | Clinical performance - as measured by clinical score data - womac pain The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. A higher score indicates a worse clinical outcome. Womac pain score is reported here. | Posted | Mean | Standard Deviation | score on a scale | 10 years |
|
|
|
| Primary | 10 Year Survivorship | Calculated Kaplan-Meier Survivorship based on revision of any component for any reason. Presented as the % of participants with the implant still in place 10 years post-operative. | Posted | Number | 95% Confidence Interval | percentage of participants | 10 years post-operative |
|
|
|
| Secondary | Oxford Hip Score | The Oxford hip score (OHS) is self-completion patient-centered outcome measure tool designed to assess disability in patients undergoing total hip replacement. The OHS consists of 12 questions about pain and disability experienced over the past four weeks. Each item has five response categories, given a score of between 1-5 (low disability to high disability). Scoring involves summating the total for each item to produce a final score between 12-60, with a higher score indicating greater disability (old Oxford score). | Posted | Mean | Standard Deviation | score on a scale | 10 years |
|
|
|
| 36 |
| 208 |
| 63 |
| 208 |
| 1 |
| 208 |
| EG001 | Group B CoC | Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic) | 25 | 449 | 89 | 449 | 2 | 449 |
|
| Device Revision | Surgical and medical procedures | Non-systematic Assessment | Revision surgery with removal of the study device (any component of the hip) |
|
| Dislocation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | First and recurrent dislocations |
|
| Fracture of femur or acetabulum | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Trochanteric Bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Total Knee Replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Total Hip replacement contralateral | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Initial cup instability | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Noise from the hip | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Heterotopic Ossification | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Facet joint | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain syndrom | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Pain - Intermittent | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Severe hip pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Deep vein Trombosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Aortic Stenosis | Cardiac disorders | Non-systematic Assessment |
|
| Sciatic Nerve Encace | Nervous system disorders | Non-systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Swelling finger | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Colostomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Femoral subsidence | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | Non-systematic Assessment |
|
| BILAT BK AMPUTATIONS | Surgical and medical procedures | Non-systematic Assessment |
|
| Ankle replacement | Surgical and medical procedures | Non-systematic Assessment |
|
| Calcar Crack | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Injury after fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | Non-systematic Assessment |
|
| LUMBAR SPINAL STENOSIS | Nervous system disorders | Non-systematic Assessment |
|
| Sponteneous bleeds | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Trochanteric Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Thigh Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| vertrebral collapse | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| CVA | Vascular disorders | Non-systematic Assessment |
|
| Terminally Ill | General disorders | Non-systematic Assessment |
|
| Pain hip | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Groin Discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| PSOAS Strain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Knee injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Knee Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | The initial CRF in the study did not allow to mark an event as serious yes/no. Therefore, all reported events are recorded as an SAE. |
|
| Fall on shoulder without injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| RIGHT CARPAL TUNNEL DECOMPRESSION | Surgical and medical procedures | Non-systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |