Clinical Outcome and OR Resource Use of Total Knee Arthro... | NCT04114201

Studies
Clinical Outcome and OR Resource Use of Total Knee Arthroplasty Using Patient-Specific or Conventional Instrumentation

NCT04114201

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Oct 3, 2019Actual

Enrollment

139Actual

Phase

Not Applicable

Conditions

Gonarthrosis

Interventions

PSI
Conventional

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2, 2012Actual

Primary Completion Date

Feb 23, 2017Actual

Completion Date

Feb 23, 2017Actual

First Submitted Date

Oct 1, 2019

First Submission Date that Met QC Criteria

Oct 2, 2019

First Posted Date

Oct 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2019

Last Update Posted Date

Oct 3, 2019Actual

Name	Class
Zimmer Biomet	INDUSTRY

Description Module

Brief Summary

Compare OR resource use and clinical Outcome after Total Knee Arthroplasty using Patient-specific or conventional Instrumentation.

Detailed Description

The aim of this study was to compare OR resource use and clinical Outcome after Total Knee Arthroplasty (TKA) using Patient-specific (PSI) or conventional Instrumentation.

For this purpose, economic variables of the surgery (number of instrument trays, setup and cut-sew-time), radiological alignment and patient reported outcomes (VAS Pain Scale, Oxford Knee Score, EQ-5D) were assessed. Cost per QALY (quality-adjusted life year) was assessed using the German DRG reimbursement and the EQ-5D.

A total of 139 TKA with PSI or conventional instrumentation were included in three Centers and were assessed before surgery, as well as 6 weeks, 6 and 12 months postoperatively.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

139Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PSI	Experimental	Patients received TKA using patient-specific Instrumentation.	Procedure: PSI
Conventional	Active Comparator	Patients received TKA conventional Instrumentation.	Procedure: Conventional

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PSI	Procedure	Implantation of a Total Knee Arthroplasty patient-specific instrumentation using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).	PSI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OR time	Operating Room (OR) time: incision to Close in minutes	during surgery

Secondary Outcomes

Measure	Description	Time Frame
OR resource use: number of instrument trays	OR Efficiency measured by number of instrument trays used	during surgery
OR Setup Time	Operating Room (OR) Setup Time in minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Painful, disabled knee joint resulting from osteoarthritis requiring primary TKA
Informed Consent: Patient has signed a "Patient Informed Consent.
Able and willing to undergo a preoperative MRI scan (for PSI cases) and full-leg, standing radiographs (all cases)
Able and willing to follow instructions and complete follow-up
Patient receiving Zimmer NexGen Solutions CR-Flex (including Gender Solutions)

Exclusion Criteria:

Patient is skeletally immature
Active Infection (including septic knee, distant infection, or osteomyelitis)
Severe hip arthrosis
Neurological disorders (including, but not limited to Parkinson's disease)
Prior unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy
Hip or knee ankylosis
Either rheumatoid or post-traumatic knee arthritis
Scheduled for simultaneous bilateral TKA
Indications of intra- and/or extra-articular deformations that would inhibit the use of PSI guides
Any metal within 150 mm of the joint line for the operative-side knee
Knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination
An existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study
A female who is pregnant or lactating
Current involvement in any personal injury litigation, medical-legal or worker's compensation claims
Arterial disease or stents that would exclude the use of a tourniquet

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Department for Orthopaedic and Trauma Surgery, Schön Klinik Lorsch		Lorsch	Hesse	64653	Germany
Department for Orthopaedic and Trauma Surgery, Helios Kliniken Mittelweser

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

ID	Term
D009938	Organizations
D004472	Health Care Economics and Organizations