Total Hip Arthroplasty
Conditions
Keywords
Total Hip Arthroplasty, Acetabular positioning, Patient specific instrumentation, Preoperative planning
Brief summary
The proposed study is a double-blinded randomized controlled trial comparing Real-time instruments with solely standardized instruments for the placement of the acetabular cup prosthesis used in total hip arthroplasty. The investigators will enroll 44 patients who have consented to total hip arthroplasty for treatment of hip pathology. This treatment is a standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. All patients will receive a pre-operative CT scan for surgical planning and comparison with post-operative CT scan. The difference in intervention between the groups will be the creation and use of real-time instrument from the pre-operative planning session. These instruments will be used for placement of an indexing peripheral guide wire to direct acetabular preparation and placement of the shell assisting standard surgical instruments. The post-operative scan will be performed within two weeks of the surgery for both the treatment and control groups. The investigators will analyze the difference in acetabular shell placement (acetabular version and abduction angle) from the pre-operatively planned CT scan. These differences will be compared between the control and experimental groups.
Interventions
DEVICEReal-time Instrumentation
To prepare the acetabulum and place the implants on the day of surgery, surgeons will receive either parts necessary to create the real-time with a surrogate model of the acetabular surface or standard surgical alignment instruments provided by the manufacturer of the implant. For the experimental group, the surgeon will be provided with 3 parts necessary to create the real-time instrument: (1) a patient-specific surrogate bone model with a built-in guide pin trajectory which was planned in the 3D planning software, (2) a non-specific plastic arm available in different sizes, and (3) bone cement. The real-time instrument is created to position a peripheral guide wire on the acetabular rim to serve as a visual aid for reaming and impacting the acetabular shell using standard reaming tools supplied by the manufacturer. Once the acetabular shell is placed, the procedure is performed in the same manner for both groups, using the standard manufacturer instruments.
PROCEDUREStandard Total Hip Arthroplasty
Total hip arthroplasty performed according to standard of care
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Subjects to be included in this protocol will be adult males and females of all races and socioeconomic status meeting the following criteria: * Primary, unilateral anterior or posterior total hip arthroplasty * 18 to 85 years old at time of surgery * Able to get a pre- and post-operative CT scan at the Cleveland Clinic
Exclusion criteria
* Significant metal in the joint that results in metal artifact on the pre--operative CT scan, thereby compromising the ability to visualize the acetabulum on the pre-operative simulator. * Pregnancy * Incarceration * Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Planned and Actual Values of Abduction | Through 2 weeks after surgery. | The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Planned and Actual Values of Version | Through 2 weeks after surgery | The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared. |
| Difference in the Time for Acetabular Preparation and Shell Placement Between the Two Groups | Intraoperatively (during surgery) | Difference in the time for acetabular preparation and shell placement between the two groups were not collected |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Total Hip Arthroplasty Each surgeon will use their standard methods of pre-operative planning using pre-operative x-rays, and complete the procedure using standard surgical instruments for total hip arthroplasty.
Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care | 10 |
| Real-time Instrumentation Pre-operative planning through 3D software with design of real-time instrument intraoperatively using bone cement and surrogate bone model for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty
Real-time Instrumentation: To prepare the acetabulum and place the implants on the day of surgery, surgeons will receive either parts necessary to create the real-time with a surrogate model of the acetabular surface or standard surgical alignment instruments provided by the manufacturer of the implant. For the experimental group, the surgeon will be provided with 3 parts necessary to create the real-time instrument: (1) a patient-specific surrogate bone model with a built-in guide pin trajectory which was planned in the 3D planning software, (2) a non-specific plastic arm available in different sizes, and (3) bone cement. The real-time instrument is created to position a peripheral guide wire on the acetabular rim to serve as a visual aid for reaming and impacting the acetabular shell using standard reaming tools supplied by the manufacturer. Once the acetabular shell is placed, the procedure is performed in the same manner for both groups, using the standard manufacturer instruments.
Standard Total Hip Arthroplasty: Total hip arthroplasty performed according to standard of care | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | Standard Total Hip Arthroplasty | Real-time Instrumentation | Total |
|---|---|---|---|
| Age, Continuous | 61.0 years STANDARD_DEVIATION 15 | 59.3 years STANDARD_DEVIATION 11.8 | 60.1 years STANDARD_DEVIATION 13.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 1 / 11 |
Outcome results
Primary
Difference Between Planned and Actual Values of Abduction
The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared.
Time frame: Through 2 weeks after surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Total Hip Arthroplasty | Difference Between Planned and Actual Values of Abduction | 5.6 degrees | Standard Deviation 13 |
| Real-time Instrumentation | Difference Between Planned and Actual Values of Abduction | 7.5 degrees | Standard Deviation 9.4 |
Secondary
Difference Between Planned and Actual Values of Version
The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared.
Time frame: Through 2 weeks after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Total Hip Arthroplasty | Difference Between Planned and Actual Values of Version | 4.1 degrees | Standard Deviation 7.8 |
| Real-time Instrumentation | Difference Between Planned and Actual Values of Version | 0.6 degrees | Standard Deviation 9.6 |
Secondary
Difference in the Time for Acetabular Preparation and Shell Placement Between the Two Groups
Difference in the time for acetabular preparation and shell placement between the two groups were not collected
Time frame: Intraoperatively (during surgery)
Population: These data were not collected