Trial Outcomes & Findings for ROBODOC® Clinical Trials: Long-Term Follow-Up (NCT NCT01831219)
NCT ID: NCT01831219
Last Updated: 2017-01-11
Results Overview
Presence of osteolysis determined by looking at patient x-rays as described by Gruen et al and Johnson et al.
COMPLETED
118 participants
14 months
2017-01-11
Participant Flow
Participant milestones
| Measure |
ROBODOC
The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
|
Conventional
The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
45
|
|
Overall Study
COMPLETED
|
40
|
21
|
|
Overall Study
NOT COMPLETED
|
33
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ROBODOC® Clinical Trials: Long-Term Follow-Up
Baseline characteristics by cohort
| Measure |
ROBODOC
n=73 Participants
The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
|
Conventional
n=45 Participants
The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
73 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Age, Continuous
|
74.2 years
STANDARD_DEVIATION 8.2 • n=99 Participants
|
72.8 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
73.5 years
STANDARD_DEVIATION 7.7 • n=206 Participants
|
|
Gender
Female
|
NA Participants
n=99 Participants
|
NA Participants
n=107 Participants
|
NA Participants
n=206 Participants
|
|
Gender
Male
|
NA Participants
n=99 Participants
|
NA Participants
n=107 Participants
|
NA Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=99 Participants
|
45 participants
n=107 Participants
|
118 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 14 monthsPresence of osteolysis determined by looking at patient x-rays as described by Gruen et al and Johnson et al.
Outcome measures
| Measure |
ROBODOC
n=45 Hips
The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
|
Conventional
n=22 Hips
The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
|
|---|---|---|
|
Presence of Osteolysis
|
2 Hips
|
2 Hips
|
PRIMARY outcome
Timeframe: 2 monthsThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to measure clinical outcome. The WOMAC total score ranges 96 (best) to 0 (worst). The WOMAC pain score ranges 0-20, the stiffness score ranges 0-8, and functional limitation score ranges 0-68.
Outcome measures
| Measure |
ROBODOC
n=45 Hips
The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
|
Conventional
n=22 Hips
The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
|
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index
|
8.44 units on a scale
Standard Deviation 11.48
|
11.32 units on a scale
Standard Deviation 11.92
|
SECONDARY outcome
Timeframe: 2 monthsThe Harris Hip Score will be measured to determine clinical outcome. The Harris Hip total score ranges 100 (best) to 0 (worst) and it is computed by the sum of the pain score (0-44 points), function (, 0-47 points), absence of deformity (4 points), and range of motion (5 points).
Outcome measures
| Measure |
ROBODOC
n=45 Hips
The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
|
Conventional
n=22 Hips
The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
|
|---|---|---|
|
Harris Hip Score
|
93.49 units on a scale
Standard Deviation 8.77
|
89.5 units on a scale
Standard Deviation 12.03
|
SECONDARY outcome
Timeframe: 2 monthsThe Health Status Questionnaire-12 (HSQ-12) will be used to measure clinical outcome. HSQ-12 total score ranges from 0 (worst) to 800 (best).
Outcome measures
| Measure |
ROBODOC
n=45 Hips
The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
|
Conventional
n=22 Hips
The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
|
|---|---|---|
|
Health Status Questionnaire-12
|
683.52 units on a scale
Standard Deviation 113.09
|
637.16 units on a scale
Standard Deviation 104.53
|
SECONDARY outcome
Timeframe: 2 monthsThe UCLA Activity Score will be used to measure clinical outcome. The UCLA Activity Score ranges 10 (best) to 0 (worst).
Outcome measures
| Measure |
ROBODOC
n=45 Hips
The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
|
Conventional
n=22 Hips
The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
|
|---|---|---|
|
UCLA Activity Score
|
6.09 units on a scale
Standard Deviation 8.44
|
5.71 units on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: 2 monthsThe Visual Analog Scale pain questionnaire will be used to measure clinical outcome. The pain VAS is a continuous scale which range from 0 (no pain) to 100 \[100-mm scale\] ("worst imaginable pain" ).
Outcome measures
| Measure |
ROBODOC
n=45 Hips
The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
|
Conventional
n=22 Hips
The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
|
|---|---|---|
|
Visual Analog Pain Score
|
4.69 units on a scale
Standard Deviation 10.15
|
6.42 units on a scale
Standard Deviation 10.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At follow-up visit (7-20 years post-operatively)Implant survivorship will be determined from the medical history CRF by comparing the percentage of ROBODOC and manual control subjects who have required revision or re-operation THA procedures on the hip in question since their original study procedure which took place 7-20 years previously.
Outcome measures
| Measure |
ROBODOC
n=45 Hips
The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
|
Conventional
n=22 Hips
The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
|
|---|---|---|
|
Number of Operated Hips That Required Revision/Reoperation
|
1 Hips
|
1 Hips
|
Adverse Events
ROBODOC
Conventional
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place