Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty
Sponsor
DePuy Orthopaedics (Industry)
Overall Status
Completed
CT.gov ID
NCT01301950
Collaborator
(none)
30
3
2
39
10
0.3
Study Details
Study Description
Brief Summary
This study is designed to compare the surgical efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique. Specifically, the purpose of this study is to collect time data to enhance the existing economic model.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The study is designed as a prospective, multi-center, controlled, non-randomized, clinical investigation to compare the efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique.
Study Design
Study Type:
Interventional
Actual Enrollment
:
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty Using TruMatch® Personalized Solutions Compared to Conventional Total Knee Arthroplasty
Actual Study Start Date
:
May 1, 2010
Actual Primary Completion Date
:
Aug 1, 2013
Actual Study Completion Date
:
Aug 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: TruMatch® Personalized Solutions Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions (Custom Patient Instrumentation) |
Other: Custom Patient Instrumentation
TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation (CPI). TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon
Other Names:
|
| Active Comparator: Conventional Total Knee Replacement Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments |
Other: Conventional Instruments
Total Knee Arthroplasty implanted using conventional instruments (non-CPI) and surgical technique.
|
Outcome Measures
Primary Outcome Measures
- Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements [Intraoperative (Time from first incision to first stitch)]
Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).
Secondary Outcome Measures
- Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete [Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)]
Operating Room setup time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes]
- Turnover Time (Time to Clean Operating Room After Surgery is Completed) [Intraoperative (Time to clean Operating Room after surgery is completed)]
Turnover Time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes].
- Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures [Intraoperative (Total duration of procedure)]
Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements .
- To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location [Intraoperative]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject is male or female and between the ages of 18 and 80 years old, inclusive.
-
Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
-
Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy
-
Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation, and co-operate with investigational procedures.
-
Subject, who, in the opinion of the Clinical Investigator, are suitable for implantation using TruMatch™ instrumentation. For example, no femoral nails/bone plates that extend into the knee, ie. within 8cm of joint line; no metal device that could cause CT scatter about the knee and no deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture are consistent with TruMatch™ instrumentation.
Exclusion Criteria:
-
The Subject is a woman who is pregnant or lactating.
-
The Subject has participated in a clinical investigation with an investigational product in the last 3 months.
-
The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
-
The Subject has previously had a prosthetic knee replacement device (any type) of the affected knee.
-
The Subject requires simultaneous bilateral total knee replacements.
-
The Subject had a contralateral TKA and that knee was previously entered in the study.
-
Subject in whom the surgeon intends to implant a knee prosthesis that is not in the PFC Sigma primary knee system.
-
Subject who has inflammatory arthritis.
-
Subject who has a Body Mass Index (BMI) of ≥ 40. (Please see Table 2-1: Definition of Terms, for BMI definition and calculation formulas).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Hip and Knee Surgery | Mooresville | Indiana | United States | 46158 |
| 2 | Pinnacle Orthopaedics | Bartlesville | Oklahoma | United States | 74006 |
| 3 | Commonwealth Orthopaedics | Reston | Virginia | United States | 20190 |
Sponsors and Collaborators
- DePuy Orthopaedics
Investigators
- Principal Investigator: Carl Painter, Pinnacle Orthopaedics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT01301950
Other Study ID Numbers:
- 08004
First Posted:
Feb 23, 2011
Last Update Posted:
Apr 10, 2019
Last Verified:
Apr 1, 2019
Keywords provided by DePuy Orthopaedics
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Conventional Total Knee Replacement | TruMatch® Personalized Solutions |
|---|---|---|
| Arm/Group Description | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon. |
| Period Title: Overall Study | ||
| STARTED | 15 | 15 |
| COMPLETED | 15 | 14 |
| NOT COMPLETED | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | TruMatch® Personalized Solutions | Conventional Total Knee Replacement | Total |
|---|---|---|---|
| Arm/Group Description | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments | Total of all reporting groups |
| Overall Participants | 15 | 15 | 30 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
62.9
(12.9)
|
62.7
(9.1)
|
62.8
(10.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
6
40%
|
11
73.3%
|
17
56.7%
|
| Male |
9
60%
|
4
26.7%
|
13
43.3%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
15
100%
|
15
100%
|
30
100%
|
Outcome Measures
| Title | Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements |
|---|---|
| Description | Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms). |
| Time Frame | Intraoperative (Time from first incision to first stitch) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Conventional Total Knee Replacement | TruMatch® Personalized Solutions |
|---|---|---|
| Arm/Group Description | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon. |
| Measure Participants | 15 | 14 |
| Mean (Standard Deviation) [minutes] |
65.8
(12.3)
|
67.3
(20.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Conventional Total Knee Replacement, TruMatch® Personalized Solutions |
|---|---|---|
| Comments | The null hypothesis was no difference in skin-to-skin time. The alternative hypothesis was that the TruMatch group time was less than the conventional group. Statistical power was anticipated to be 86% with 40 enrolled subjects based upon a Cohen's D effect size of 1. The Sponsor had difficulty identifying and recruiting sites suitable for participation. The statistically required sample size (N=40) was therefore not obtained, causing the group comparison to be statistically underpowered. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.54 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete |
|---|---|
| Description | Operating Room setup time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes] |
| Time Frame | Intraoperative (Operating Room cleaned up from previous case to surgical draping complete) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Conventional Total Knee Replacement | TruMatch® Personalized Solutions |
|---|---|---|
| Arm/Group Description | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon. |
| Measure Participants | 15 | 14 |
| Mean (Standard Deviation) [minutes] |
28.9
(15.0)
|
28.8
(14.4)
|
| Title | Turnover Time (Time to Clean Operating Room After Surgery is Completed) |
|---|---|
| Description | Turnover Time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes]. |
| Time Frame | Intraoperative (Time to clean Operating Room after surgery is completed) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 1 site (9 subjects) was excluded from Turnover Time analysis as this substep could not be accurately assessed due to unexpected difficulties during video collection. |
| Arm/Group Title | Conventional Total Knee Replacement | TruMatch® Personalized Solutions |
|---|---|---|
| Arm/Group Description | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon. |
| Measure Participants | 10 | 10 |
| Mean (Standard Deviation) [minutes] |
10.1
(4.8)
|
11.4
(2.8)
|
| Title | Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures |
|---|---|
| Description | Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements . |
| Time Frame | Intraoperative (Total duration of procedure) |
Outcome Measure Data
| Analysis Population Description |
|---|
| No cost data were collected, resulting in a sample size of 0. |
| Arm/Group Title | Conventional Total Knee Replacement | TruMatch® Personalized Solutions |
|---|---|---|
| Arm/Group Description | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon. |
| Measure Participants | 0 | 0 |
| Title | To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location |
|---|---|
| Description | |
| Time Frame | Intraoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| No operating room efficiency data was analyzed as a function of geography and institution, resulting in a sample size of 0. |
| Arm/Group Title | Conventional Total Knee Replacement | TruMatch® Personalized Solutions |
|---|---|---|
| Arm/Group Description | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon. |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | Intraoperative | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | TruMatch™ Personalized Solutions | Conventional Total Knee Replacement | ||
| Arm/Group Description | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions Instrument: TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments | ||
All Cause Mortality |
||||
| TruMatch™ Personalized Solutions | Conventional Total Knee Replacement | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| TruMatch™ Personalized Solutions | Conventional Total Knee Replacement | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/15 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| TruMatch™ Personalized Solutions | Conventional Total Knee Replacement | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/15 (0%) | ||
Limitations/Caveats
A statistically powered sample size was not obtained; Two secondary objectives (compare costs & compare differences in OR efficiency as a function of institution type & geographic location) could not be assessed as originally intended by the protocol
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Sam Himden, Clinical Portfolio Leader |
|---|---|
| Organization | DePuy Synthes |
| Phone | 574-372-7231 |
| shimden@its.jnj.com |
Responsible Party:
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT01301950
Other Study ID Numbers:
- 08004
First Posted:
Feb 23, 2011
Last Update Posted:
Apr 10, 2019
Last Verified:
Apr 1, 2019