Trial Outcomes & Findings for Minimally Invasive Surgery of the Hip Versus Standard Approach (NCT NCT00261040)
NCT ID: NCT00261040
Last Updated: 2020-03-27
Results Overview
Hospital length of stay
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
24 months
Results posted on
2020-03-27
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Minimally Invasive Surgery (MIS)
n=20 Participants
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.
|
Standard Surgery
n=20 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
40 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 24 monthsHospital length of stay
Outcome measures
| Measure |
Minimally Invasive Surgery (MIS)
n=18 Participants
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.
|
Standard Surgery
n=19 Participants
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.
|
|---|---|---|
|
Clinical Outcomes
|
5.39 Days
Standard Deviation 1.819
|
5.74 Days
Standard Deviation 1.522
|
SECONDARY outcome
Timeframe: 24 monthsQuestionnaire 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."
Outcome measures
| Measure |
Minimally Invasive Surgery (MIS)
n=20 Participants
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.
|
Standard Surgery
n=20 Participants
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.
|
|---|---|---|
|
Harris Hip Score
|
90.4031 units on a scale
Standard Deviation 8.92579
|
90.3011 units on a scale
Standard Deviation 12.54267
|
SECONDARY outcome
Timeframe: 3 monthsA 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.
Outcome measures
| Measure |
Minimally Invasive Surgery (MIS)
n=20 Participants
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.
|
Standard Surgery
n=20 Participants
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.
|
|---|---|---|
|
Change in Timed Get-up-and-Go Test (TUG)
|
11.01 seconds
Standard Deviation 4.937
|
12.03 seconds
Standard Deviation 2.639
|
SECONDARY outcome
Timeframe: Day of SurgeryDuration of the surgical procedure
Outcome measures
| Measure |
Minimally Invasive Surgery (MIS)
n=20 Participants
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.
|
Standard Surgery
n=20 Participants
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.
|
|---|---|---|
|
Operating Time Duration
|
95.20 minutes
Standard Deviation 22.94
|
87.70 minutes
Standard Deviation 23.63
|
SECONDARY outcome
Timeframe: Day of surgeryEstimated blood loss during the operative procedure
Outcome measures
| Measure |
Minimally Invasive Surgery (MIS)
n=20 Participants
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.
|
Standard Surgery
n=20 Participants
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.
|
|---|---|---|
|
Estimated Blood Loss
|
460 Millilitres (mL)
Standard Deviation 215.578
|
462.50 Millilitres (mL)
Standard Deviation 152.069
|
Adverse Events
Minimally Invasive Surgery (MIS)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Surgery
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Minimally Invasive Surgery (MIS)
n=20 participants at risk
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.
|
Standard Surgery
n=20 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Patient mortality
|
5.0%
1/20 • 24 months
|
0.00%
0/20 • 24 months
|
|
Cardiac disorders
Myocardial Infarction
|
5.0%
1/20 • 24 months
|
0.00%
0/20 • 24 months
|
Other adverse events
| Measure |
Minimally Invasive Surgery (MIS)
n=20 participants at risk
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.
|
Standard Surgery
n=20 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Operative Complication
|
0.00%
0/20 • 24 months
|
5.0%
1/20 • 24 months
|
Additional Information
Dr Paul Kim
The Ottawa Hospital - Ottawa Hospital Research Institute
Phone: 613-737-8920
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place