Trial Outcomes & Findings for Oxford Signature vs. Conventional Global Study (NCT NCT01763684)
NCT ID: NCT01763684
Last Updated: 2021-04-23
Results Overview
Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
266 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-04-23
Participant Flow
Bi-lateral treatment was not recorded. Each treated knee is counted as 1 participant.
Participant milestones
| Measure |
Signature Custom Guides
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
133
|
|
Overall Study
Completed Surgery
|
126
|
127
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
133
|
133
|
Reasons for withdrawal
| Measure |
Signature Custom Guides
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Overall Study
Study terminated early due to low enrollment
|
126
|
127
|
|
Overall Study
Study surgery not performed
|
7
|
6
|
Baseline Characteristics
5 patients age not reported
Baseline characteristics by cohort
| Measure |
Signature Custom Guides
n=126 Participants
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=127 Participants
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=122 Participants • 5 patients age not reported
|
0 Participants
n=126 Participants • 5 patients age not reported
|
0 Participants
n=248 Participants • 5 patients age not reported
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=122 Participants • 5 patients age not reported
|
77 Participants
n=126 Participants • 5 patients age not reported
|
154 Participants
n=248 Participants • 5 patients age not reported
|
|
Age, Categorical
>=65 years
|
45 Participants
n=122 Participants • 5 patients age not reported
|
49 Participants
n=126 Participants • 5 patients age not reported
|
94 Participants
n=248 Participants • 5 patients age not reported
|
|
Age, Continuous
|
63.2 Years
STANDARD_DEVIATION 10.0 • n=126 Participants • 5 patient conventional age missing
|
62.5 Years
STANDARD_DEVIATION 9.1 • n=122 Participants • 5 patient conventional age missing
|
62.9 Years
STANDARD_DEVIATION 9.7 • n=248 Participants • 5 patient conventional age missing
|
|
Sex: Female, Male
Female
|
56 Participants
n=126 Participants • 5 patients gender not reported
|
68 Participants
n=122 Participants • 5 patients gender not reported
|
124 Participants
n=248 Participants • 5 patients gender not reported
|
|
Sex: Female, Male
Male
|
70 Participants
n=126 Participants • 5 patients gender not reported
|
54 Participants
n=122 Participants • 5 patients gender not reported
|
124 Participants
n=248 Participants • 5 patients gender not reported
|
|
Region of Enrollment
United States
|
95 participants
n=126 Participants • 5 subjects no region data available
|
71 participants
n=122 Participants • 5 subjects no region data available
|
166 participants
n=248 Participants • 5 subjects no region data available
|
|
Region of Enrollment
Europe
|
25 participants
n=126 Participants • 5 subjects no region data available
|
47 participants
n=122 Participants • 5 subjects no region data available
|
72 participants
n=248 Participants • 5 subjects no region data available
|
|
Region of Enrollment
Australia
|
6 participants
n=126 Participants • 5 subjects no region data available
|
4 participants
n=122 Participants • 5 subjects no region data available
|
10 participants
n=248 Participants • 5 subjects no region data available
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Data from all patients as treated
Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles.
Outcome measures
| Measure |
Signature Custom Guides
n=100 Participants
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=94 Participants
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Percentage of Knees Achieving Optimal Alignment
|
45 percentage of total
|
29 percentage of total
|
SECONDARY outcome
Timeframe: OperativePopulation: All patients as treated
Number of Instrument cases used to complete index surgery.
Outcome measures
| Measure |
Signature Custom Guides
n=122 Participants
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=126 Participants
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Instruments Used During Surgery
|
4.2 Instrument cases
Standard Deviation 0.76
|
3.8 Instrument cases
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: 1 YearPopulation: All patients, as treated, reaching the 1 year follow up datapoint with Knee Society Score score completed
Functional Score from Knee Society Score. These are 3 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Outcome measures
| Measure |
Signature Custom Guides
n=58 Participants
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=60 Participants
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Knee Society Functional Score
|
88.1 units on a scale
Standard Deviation 18.2
|
91.8 units on a scale
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Directly PostoperativePopulation: All patients as treated with post-operative CT collected
Mechanical Leg Alignment of Components (degrees): Difference of Femoral Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Outcome measures
| Measure |
Signature Custom Guides
n=100 Participants
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=94 Participants
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Leg Alignment Femoral Varus/Valgus
|
3.55 Degrees
Standard Deviation 2.7
|
4.75 Degrees
Standard Deviation 3.53
|
SECONDARY outcome
Timeframe: Right after surgery (up to 2 hours after surgery)Population: All patients as treated for which blood loss is recorded
Blood Loss during surgery
Outcome measures
| Measure |
Signature Custom Guides
n=49 Participants
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=79 Participants
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Blood Loss
|
81.9 ml
Standard Deviation 84.5
|
54.8 ml
Standard Deviation 73.0
|
SECONDARY outcome
Timeframe: 1 YearPopulation: All patients, as treated, reaching the 1 year follow up datapoint with Knee Society Score completed
Objective score from Knee Society Score. These are 7 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Outcome measures
| Measure |
Signature Custom Guides
n=58 Participants
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=60 Participants
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Knee Society Objective Score
|
93.3 units on a scale from 0 to 100
Standard Deviation 16.3
|
95.0 units on a scale from 0 to 100
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: 1 YearPopulation: All patients, as treated, reaching the 1 year follow up datapoint with Oxford Knee Score completed
Oxford Knee Score (OKS). Scored from 0 to 48 with 0 being the worst possible outcome and 48 being the best outcome
Outcome measures
| Measure |
Signature Custom Guides
n=58 Participants
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=57 Participants
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Oxford Knee Score
|
42.6 units on a scale
Standard Deviation 6.1
|
44.0 units on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 1 YearPopulation: All patients, as treated, reaching the 1 year follow up datapoint with EQ5D score completed
EuroQol 5D Quality of Life score. Range from 0 to 1 with 1 being the best outcome.
Outcome measures
| Measure |
Signature Custom Guides
n=58 Participants
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=58 Participants
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
EQ5D Score
|
0.88 units on a scale from 0 to 1
Standard Deviation 0.15
|
0.9 units on a scale from 0 to 1
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Directly PostoperativePopulation: All patients as treated with post-operative CT collected
Mechanical Leg Alignment of Components (degrees): Difference of Femoral Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle
Outcome measures
| Measure |
Signature Custom Guides
n=89 Participants
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=88 Participants
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Leg Alignment Femoral Flexion/Extension
|
3.48 Degrees
Standard Deviation 2.7
|
4.59 Degrees
Standard Deviation 3.34
|
SECONDARY outcome
Timeframe: Directly PostoperativePopulation: All patients as treated with post-operative CT collected
Mechanical Leg Alignment of Components (degrees): Difference of Tibial Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Outcome measures
| Measure |
Signature Custom Guides
n=100 Participants
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=91 Participants
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Leg Alignment Tibial Varus/Valgus
|
4.04 Degrees
Standard Deviation 2.41
|
4.10 Degrees
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Directly PostoperativePopulation: All patients as treated with post-operative CT collected
Mechanical Leg Alignment of Components (degrees): Difference of Tibial Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle
Outcome measures
| Measure |
Signature Custom Guides
n=94 Participants
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=100 Participants
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Leg Alignment Tibial Flexion/Extension
|
2.47 Degrees
Standard Deviation 2.06
|
2.96 Degrees
Standard Deviation 2.04
|
Adverse Events
Signature Custom Guides
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Conventional Instrumentation
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Signature Custom Guides
n=133 participants at risk
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=133 participants at risk
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Gastrointestinal disorders
PERFORATED DIVERTICULITIS, HINCHEY IV
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
DEHISCENCE OF PROXIMAL MEDIAL CAPSULAR SUTURE
|
0.75%
1/133 • Number of events 1
|
0.00%
0/133
|
|
Gastrointestinal disorders
LAPARAOSCIPIC GASTRIC BYPASS
|
0.75%
1/133 • Number of events 1
|
0.00%
0/133
|
|
Musculoskeletal and connective tissue disorders
ARTHROSCOPIC PROCEDURE
|
0.75%
1/133 • Number of events 1
|
0.00%
0/133
|
|
Musculoskeletal and connective tissue disorders
SHOULDER PAIN
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
|
General disorders
Patient Fall
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Knee Gonarthrosis
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
|
General disorders
Unkown event
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
Other adverse events
| Measure |
Signature Custom Guides
n=133 participants at risk
Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
|
Conventional Instrumentation
n=133 participants at risk
Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
|
|---|---|---|
|
Injury, poisoning and procedural complications
2 MM BLOOD BLISTER ON INCISION ON OPERATIVE KNEE
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
DEGENERATIVE DISC DISEASE LUMBAR SPINE
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
|
Injury, poisoning and procedural complications
DELAYED WOUND HEALING
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Disease Progression
|
0.75%
1/133 • Number of events 1
|
0.00%
0/133
|
|
General disorders
Fall
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
FEELING OF RIGHT KNEE GIVING WAY
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
5.3%
7/133 • Number of events 7
|
2.3%
3/133 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Knee popping/clicking
|
0.00%
0/133
|
2.3%
3/133 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Knee Swelling
|
0.75%
1/133 • Number of events 1
|
1.5%
2/133 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
PATELLA TENDONITIS
|
0.75%
1/133 • Number of events 1
|
0.00%
0/133
|
|
Injury, poisoning and procedural complications
POST-OP NAUSEA
|
1.5%
2/133 • Number of events 2
|
1.5%
2/133 • Number of events 2
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/133
|
0.75%
1/133 • Number of events 1
|
Additional Information
Linda Meijer, Clinical Operations Manager
Zimmer Biomet
Phone: +31786292935
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place