Painful Knee Prosthesis. Relationship Between Endogenous... | NCT01811888

Studies
Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.

NCT01811888

Sponsor

Parc de Salut Mar

Status

Completed

Last Update Posted

Mar 31, 2016Estimated

Enrollment

180Actual

Phase

Not provided

Conditions

Knee Osteoarthritis

Interventions

Quantitative sensory testing (QST)

Countries

Spain

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

Mar 2016

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

Jan 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Mar 13, 2013

First Submission Date that Met QC Criteria

Mar 13, 2013

First Posted Date

Mar 15, 2013Estimated

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

Mar 29, 2016

Last Update Posted Date

Mar 31, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective, observational study, aimed to establish the relationship between an inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the probability to develop chronic pain after surgery (persistent post surgical pain). Endogenous analgesia efficiency will be measured during the month previous to surgery using quantitative sensory testing (QST). Persistent post surgical pain will be defined as presence of pain in movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with knee osteoarthritis			Behavioral: Quantitative sensory testing (QST)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quantitative sensory testing (QST)	Behavioral		Patients with knee osteoarthritis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of pain in the operated knee, 6 months after surgery.		Presence of pain greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.

Secondary Outcomes

Measure	Description	Time Frame
Endogenous Analgesia efficiency measured with QST (Quantitative sensory testing) techniques.		From start of recruitment untill day 180.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 18 patients
Scheduled for primary total knee arthroplasty
Disposition to visits and scheduled tests

Exclusion Criteria:

Previous surgery on knee to be operated
Documented peripheral neuropathy
Severe disease or condition that could potentially interfere with interpretation of tests.

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

Patients with knee osteoarthritis scheduled for total knee artheroplasty.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Servicio d'Anestesia i Reanimació, Hospital del Mar		Barcelona	Barcelona	08003	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33817538	Derived	Dursteler C, Salazar Y, Rodriguez U, Pelfort X, Verdie LP. Conditioned pain modulation predicts persistent pain after knee replacement surgery. Pain Rep. 2021 Mar 29;6(1):e910. doi: 10.1097/PR9.0000000000000910. eCollection 2021 Jan-Feb.

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