Avascular Necrosis, Noninflammatory Degenerative Joint Disease, Rheumatoid Arthritis
Conditions
Keywords
hip, Signature
Brief summary
The primary purpose of this pilot study is to evaluate the accuracy of cup placement between two instrumentation technologies: Cutting Guide and Conventional Instrumentation.
Detailed description
Using a more advanced surgical technique may assist surgeons and patients in a variety of ways including identifying a specific-size for the prosthesis prior to surgery, increasing operating room efficiency, and reducing the number of traditional instruments needed. This may reduce cost associated with the instrument inventory and instrument sterilization. Operating time may also be reduced, potentially decreasing the patient's risk of infection. However, before these hypotheses can be tested, it is important to fully understand the efficacy and accuracy of Signature Custom Guides and their use in Total Hip Arthroplasty.
Interventions
DEVICEPosterior Lateral Approach Total Hip Arthroplasty
All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.
Sponsors
Zimmer Biomet
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects with one of the following indication: * Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. * Rheumatoid arthritis. * Correction of functional deformity. * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. Additional inclusion criteria include: * Subjects requiring primary total hip arthroplasty * 20 to 75 years of age * Subjects with a diagnosis of osteoarthritis or traumatic arthritis * Subjects willing to return for follow-up evaluations. * Subjects who can read, understand study information and give written consent without representation of a legally authorized representative. * Bilateral patients are included if staged. * Only Posterior Lateral Approach can be used for inclusion in this study
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative Room Time | Surgery | Average operative time |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Signature Cutting Guides Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery.
Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach. | 14 |
| Conventional Instrumentation Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery.
Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach. | 10 |
| Total | 24 |
Baseline characteristics
| Characteristic | Signature Cutting Guides | Conventional Instrumentation | Total |
|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 9.9 | 68.8 years STANDARD_DEVIATION 6.4 | 62.1 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment France | 3 Participants | 10 Participants | 13 Participants |
| Region of Enrollment United States | 11 Participants | 0 Participants | 11 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 10 |
| other Total, other adverse events | 1 / 14 | 0 / 10 |
| serious Total, serious adverse events | 0 / 14 | 0 / 10 |
Outcome results
Primary
Operative Room Time
Average operative time
Time frame: Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Signature Cutting Guides | Operative Room Time | 84.7 minutes | Standard Deviation 12 |
| Conventional Instrumentation | Operative Room Time | 78.3 minutes | Standard Deviation 3.8 |