Arthroplasty, Replacement, Hip
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPelvic Alignment Level (PAL) Instrument
Pelvic Alignment Level Instrument Used
DEVICENo Pelvic Alignment Level (PAL) Instrument
No Pelvic Alignment Level Instrument Used
Sponsors
Stryker Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has signed an IRB approved, evaluation specific Informed Patient Consent Form. * Patient is a male or non-pregnant female age 18 years or older at time of enrollment. * Patient clinically qualifies for total hip arthroplastic surgery, based on physical examination and medical history. * Patient must have a diagnosis of: osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, failed fracture fixation or rheumatoid arthritis.
Exclusion criteria
* Patient's anatomy precludes a cup placement of 45° inclination and 20° anteversion. * Patient has an active infection within the affected hip joint. * Patient is a prisoner. * Patient has plans to relocate to another geographic area before the completion of the evaluation.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 4 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study Termination | 3 | 4 |
Baseline characteristics
| Characteristic | PAL (Pelvic Alignment Level) | No PAL (No Pelvic Alignment Level) | Total |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 12.9 | 65.9 years STANDARD_DEVIATION 4.1 | 65.5 years STANDARD_DEVIATION 8 |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 4 |
| serious Total, serious adverse events | 1 / 3 | 0 / 4 |
Outcome results
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.
Time frame: 6 week follow-up
Population: The study was terminated early, therefore, primary or secondary measures were not assessed.
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.
Time frame: 6 week follow-up
Population: The study was terminated early, therefore, primary or secondary measures were not assessed.