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Lagging enrollment
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The study is conducted to evaluate the performance of the Pelvic Alignment Level (PAL) instrument in achieving desired acetabular position, desired leg length and offset after Total Hip Replacement (THR) reconstruction.
Total hip replacement (THR) has been a sucessful treatment for cases of degenerative joint diseases. However, post operative complications such as dislocations, osteolysis, component wear and migration are still a concern. It has been noted in the scientific literature that precise acetabular cup position helps reduce such post operative complications. The Pelvic Alignment Level (PAL) offers this solution by assessing pelvic motion and optimizing implant position without the need for intra-operative fluoroscopy or a large capital expenditure. The focus of this study is to evaluate the clinical outcomes (acetabular cup placement, femoral offset, and leg length) of using the PAL instrument to those without using PAL instrument during total hip replacement. This will be a prospective, post market, randomized multi-center clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic Alignment Level (PAL) | Other | Pelvic Alignment Level Instrument Used |
|
| No Pelvic Alignment Level (PAL) | Other | No Pelvic Alignment Level Instrument Used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic Alignment Level (PAL) Instrument | Device | Pelvic Alignment Level Instrument Used |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument. | 6 week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Surgical Success of Achieving Preoperative Targets for Leg Length and Femoral Offset, or be Able to Document Changes to Pre-operative Leg Length and Offset, Using the PAL Compared to Surgeries Without Using the PAL Instrument. | 6 week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur L. Malkani, MD | Healthcare Center for Advanced Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Center for Advanced Medicine | Louisville | Kentucky | 40202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PAL (Pelvic Alignment Level) | The cases randomized into the "PAL Group" will have total hip replacement surgery performed utilizing the PAL instrument. Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument. |
| FG001 | No PAL (No Pelvic Alignment Level) | The cases randomized into the "No PAL Group" will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group. Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PAL (Pelvic Alignment Level) | The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument. Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument. |
| BG001 | No PAL (No Pelvic Alignment Level) |
| 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 Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument. | The study was terminated early, therefore, primary or secondary measures were not assessed. | Posted | 6 week follow-up |
|
6 weeks
Industry Standard Adverse Event (AE) terms (e.g. MedDRA) were not used for AE data collection. Specific AE terms were not used for all AEs collected.
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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 | PAL (Pelvic Alignment Level) | The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument. Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative Site | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Stryker Orthopedics | 201-831-5401 | ellen.axelson@stryker.com |
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| No Pelvic Alignment Level (PAL) Instrument | Device | No Pelvic Alignment Level Instrument Used |
|
The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group. Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | To Evaluate the Surgical Success of Achieving Preoperative Targets for Leg Length and Femoral Offset, or be Able to Document Changes to Pre-operative Leg Length and Offset, Using the PAL Compared to Surgeries Without Using the PAL Instrument. | The study was terminated early, therefore, primary or secondary measures were not assessed. | Posted | 6 week follow-up |
|
|
| 1 |
| 3 |
| 0 |
| 3 |
| EG001 | No PAL (No Pelvic Alignment Level) | The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group. Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument. | 0 | 4 | 0 | 4 |
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