Hip Arthroplasty, Osteoarthritis
Conditions
Keywords
Osteoarthritis, Total Hip Arthroplasty, Minimally Invasive Surgery
Brief summary
The purpose of this study is to determine if there is a difference in terms of length of hospital stay and post-operative outcomes between patients whose total hip replacement surgery is performed with a minimally invasive versus standard surgical approach.
Detailed description
Traditional techniques for total hip arthroplasty (THA) require complete visualization of the acetabulum and proximal femur since anatomic landmarks are crucial for correct orientation of the prosthetic components. All surgeons are taught that a wide surgical exposure is one of the most important factors in performing successful THA. Traditionally, it was impossible to achieve accurate fixation and orientation of the components without complete visualization of bony landmarks. These extensile exposures facilitate accurate implant alignment, but at the expense of more extensive soft tissue dissection. Little clinical research has been undertaken to relate the surgical approach to postoperative complications or patient function. Furthermore, despite the good overall results of THA, the recovery time to improved function can be lengthy. Blood loss is expected to be directly related to the extent of the surgical exposure and to influence patients outcomes. Based upon these facts, an important principle of arthroplasty surgery is to minimize the amount of soft tissue trauma while being able to achieve the surgical goal of reconstructing the arthritic hip joint. By definition, minimally invasive surgical (MIS) procedures result in less soft tissue disruption, which in turn should reduce pain, expedite healing, decrease recovery time, and potentially reduce the number of associated complications.
Interventions
PROCEDUREMinimally Invasive Surgery
In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.
PROCEDUREStandard Surgery
The standard way that an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision.
Sponsors
Zimmer Biomet
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
BMI \> 30 kg/m2 No prior ipsilateral hip surgery Osteoarthritis
Exclusion criteria
Patients with grossly distorted bony anatomy whereby standard implants are contraindicated; i.e. congenital dysplasia of the hip, proximal femoral abnormalities, etc Rheumatoid Arthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes | 24 months | Hospital length of stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 24 months | Questionnaire to measure health outcome status. An index score of 100 is the highest score and is indicative of better outcome, while 0 is the lowest score and indicative of worse outcome. With regards to health, a score between 90-100 is considered Excellent. 80-89 is considered Good. 70-79 is considered Fair. Less than 70 is considered Poor. |
| Change in Timed Get-up-and-Go Test (TUG) | 3 months | A timed assessment to assess a participants mobility. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. A faster time is indicative of better mobility, while a slower time is indicative of worse mobility. |
| Operating Time Duration | Day of Surgery | Duration of the surgical procedure |
| Estimated Blood Loss | Day of surgery | Estimated blood loss during the operative procedure |
Participant flow
Pre-assignment details
Patient recruitment occurred at the Ottawa Hospital (General Campus) by one of two co-investigator surgeons trained in MIS of the hip. Randomization occurred on the day of surgery in order to minimize the potential number of dropouts.
Participants by arm
| Arm | Count |
|---|---|
| Minimally Invasive Surgery (MIS) In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.
Minimally Invasive Surgery: In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her. | 20 |
| Standard Surgery The standard way an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision
Standard Surgery: The standard way that an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Standard Surgery | Total | Minimally Invasive Surgery (MIS) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 25 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 15 Participants | 8 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 11 Participants | 23 Participants | 12 Participants |
| Sex: Female, Male Male | 9 Participants | 17 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 1 / 20 |
| serious Total, serious adverse events | 2 / 20 | 0 / 20 |
Outcome results
Primary
Clinical Outcomes
Hospital length of stay
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimally Invasive Surgery (MIS) | Clinical Outcomes | 5.39 Days | Standard Deviation 1.819 |
| Standard Surgery | Clinical Outcomes | 5.74 Days | Standard Deviation 1.522 |
Secondary
Change in Timed Get-up-and-Go Test (TUG)
A timed assessment to assess a participants mobility. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. A faster time is indicative of better mobility, while a slower time is indicative of worse mobility.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimally Invasive Surgery (MIS) | Change in Timed Get-up-and-Go Test (TUG) | 11.01 seconds | Standard Deviation 4.937 |
| Standard Surgery | Change in Timed Get-up-and-Go Test (TUG) | 12.03 seconds | Standard Deviation 2.639 |
Secondary
Estimated Blood Loss
Estimated blood loss during the operative procedure
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimally Invasive Surgery (MIS) | Estimated Blood Loss | 460 Millilitres (mL) | Standard Deviation 215.578 |
| Standard Surgery | Estimated Blood Loss | 462.50 Millilitres (mL) | Standard Deviation 152.069 |
Secondary
Harris Hip Score
Questionnaire to measure health outcome status. An index score of 100 is the highest score and is indicative of better outcome, while 0 is the lowest score and indicative of worse outcome. With regards to health, a score between 90-100 is considered Excellent. 80-89 is considered Good. 70-79 is considered Fair. Less than 70 is considered Poor.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimally Invasive Surgery (MIS) | Harris Hip Score | 90.4031 units on a scale | Standard Deviation 8.92579 |
| Standard Surgery | Harris Hip Score | 90.3011 units on a scale | Standard Deviation 12.54267 |
Secondary
Operating Time Duration
Duration of the surgical procedure
Time frame: Day of Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimally Invasive Surgery (MIS) | Operating Time Duration | 95.20 minutes | Standard Deviation 22.94 |
| Standard Surgery | Operating Time Duration | 87.70 minutes | Standard Deviation 23.63 |