Hip Osteoarthritis, Surgery
Conditions
Keywords
clinical trial, randomization, hip arthroplasty
Brief summary
This study will involve a quantitative assessment of prospectively collected computed tomography, radiographic and patient outcomes data from multiple centers. Specifically looking at acetabular cup placement during Total Hip Arthroplasty by either traditional or robotic-arm assisted placement.
Detailed description
The incidence of dislocation following total hip arthroplasty (THA) has been reported to be from 1% to as much as 3.2%. The demand for THA is expected to increase. Post- dislocation solutions include closed reduction, open reduction, THA revision, and constrained cup, conversion to hemiarthroplasty, allograft or girdlestone resection. These solutions are often costly, painful and can involve substantial additional risks and complications. Acetabular cup placement is an important factor in the stability of the THA. Cup malpositioning has been associated with bearing surface ware and dislocation. For most patients, acceptable angles for abduction are 40° abduction (±10°) and 20° (±5°) version. However, malpositioning continues to occur resulting in cup angles outside acceptable ranges and leaving patients with an increased risk of dislocation. This objective of this study is to examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
Interventions
PROCEDURERobotic-Arm Assisted THA
The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
Sponsors
Stryker Nordic
West Penn Allegheny Health System
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients requiring primary total hip arthroplasty 2. Patients willing and able to comply with follow-up requirements 3. Patients willing to sign an Institutional Review Board approved informed consent form.
Exclusion criteria
1. Patients with Body Mass Index \>45 2. Patients who are \<18 years of age 3. Patients with an active infection or suspected latent infection in or about the hip joint 4. Bone stock that is inadequate for support or fixation of the prosthesis 5. Previous major hip surgery excluding hip arthroscopy 6. Total hip arthroplasty using cement fixation or resurfacing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version. | 6 months | Accuracy of cup placement will be measured by absolute value of degrees from target version (40 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone. |
| Change in Patient Reported Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) Survey Over 1 Year Period. | 1 Year | The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process . To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. To calculate the total HOOS score the subscales need to be summed up. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Survey Over a 1 Year Period. | 1year | The PROMIS Global-10 is a global health quality of life patient reported outcome tool. It is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It measures symptoms, functioning, and healthcare quality of life for a wide variety of conditions. The PROMIS Global-10 consists of 10 questions assessing physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. 7 questions inquire about health in general and 3 questions assess emotional problems, fatigue and pain in the last 7 days. PROMIS 10 Global Physical Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse physical health and 20 equals the best physical health). PROMIS 10 Global Mental Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse mental health and 20 equals the best mental health) |
| Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination. | 6 months | Accuracy of cup placement will be measured by absolute value of degrees from target inclination (20 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone. |
| Adherence to Lewinnek Safe Zone | 6 month | 5-25 degrees of anteversion; 30-50 degrees of inclination. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Traditional THA. | 20 |
| Intervention Robotic-arm assisted THA.
Robotic-Arm Assisted THA: The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA. | 17 |
| Total | 37 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 7 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 17 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 1 / 20 |
Outcome results
Primary
Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination.
Accuracy of cup placement will be measured by absolute value of degrees from target inclination (20 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination. | 4.73 degrees error in inclination | Standard Deviation 3.58 |
| Intervention | Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination. | 2.93 degrees error in inclination | Standard Deviation 2.42 |
Primary
Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version.
Accuracy of cup placement will be measured by absolute value of degrees from target version (40 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version. | 5.95 degrees error in anteversion | Standard Deviation 2.78 |
| Intervention | Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version. | 4.26 degrees error in anteversion | Standard Deviation 3.19 |
Primary
Adherence to Lewinnek Safe Zone
5-25 degrees of anteversion; 30-50 degrees of inclination.
Time frame: 6 month
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Adherence to Lewinnek Safe Zone | version in the Lewinnek safe zone | 14 Participants |
| Control | Adherence to Lewinnek Safe Zone | inclination in the Lewinnek safe zone | 17 Participants |
| Intervention | Adherence to Lewinnek Safe Zone | version in the Lewinnek safe zone | 16 Participants |
| Intervention | Adherence to Lewinnek Safe Zone | inclination in the Lewinnek safe zone | 17 Participants |
Primary
Change in Patient Reported Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) Survey Over 1 Year Period.
The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process . To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. To calculate the total HOOS score the subscales need to be summed up.
Time frame: 1 Year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Patient Reported Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) Survey Over 1 Year Period. | HOOS ADL (activities of daily living) | 41.31 score on a scale | Standard Deviation 9.98 |
| Control | Change in Patient Reported Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) Survey Over 1 Year Period. | HOOS QOL (quality of life) | 43.75 score on a scale | Standard Deviation 11.46 |
| Control | Change in Patient Reported Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) Survey Over 1 Year Period. | HOOS Symptoms | 32.27 score on a scale | Standard Deviation 10.65 |
| Control | Change in Patient Reported Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) Survey Over 1 Year Period. | HOOS Sports/recreation | 31.82 score on a scale | Standard Deviation 12.93 |
| Control | Change in Patient Reported Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) Survey Over 1 Year Period. | HOOS Pain Improvement | 39.54 score on a scale | Standard Deviation 9.98 |
| Intervention | Change in Patient Reported Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) Survey Over 1 Year Period. | HOOS Sports/recreation | 58.85 score on a scale | Standard Deviation 6.63 |
| Intervention | Change in Patient Reported Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) Survey Over 1 Year Period. | HOOS Pain Improvement | 47.92 score on a scale | Standard Deviation 6.34 |
| Intervention | Change in Patient Reported Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) Survey Over 1 Year Period. | HOOS ADL (activities of daily living) | 48.40 score on a scale | Standard Deviation 4.59 |
| Intervention | Change in Patient Reported Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) Survey Over 1 Year Period. | HOOS Symptoms | 59.17 score on a scale | Standard Deviation 4.99 |
| Intervention | Change in Patient Reported Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) Survey Over 1 Year Period. | HOOS QOL (quality of life) | 53.13 score on a scale | Standard Deviation 9.05 |
Primary
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Survey Over a 1 Year Period.
The PROMIS Global-10 is a global health quality of life patient reported outcome tool. It is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It measures symptoms, functioning, and healthcare quality of life for a wide variety of conditions. The PROMIS Global-10 consists of 10 questions assessing physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. 7 questions inquire about health in general and 3 questions assess emotional problems, fatigue and pain in the last 7 days. PROMIS 10 Global Physical Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse physical health and 20 equals the best physical health). PROMIS 10 Global Mental Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse mental health and 20 equals the best mental health)
Time frame: 1year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Survey Over a 1 Year Period. | PROMIS 10 Global Physical Health | 10.11 score on a scale | Standard Deviation 3.01 |
| Control | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Survey Over a 1 Year Period. | PROMIS 10 Global Mental Health | 3.92 score on a scale | Standard Deviation 3.38 |
| Intervention | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Survey Over a 1 Year Period. | PROMIS 10 Global Physical Health | 11.37 score on a scale | Standard Deviation 2.72 |
| Intervention | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Survey Over a 1 Year Period. | PROMIS 10 Global Mental Health | 2.88 score on a scale | Standard Deviation 1.73 |