Outcome After Arthroscopic Surgery in Patients Treated Wi... | NCT02945995

Studies
Outcome After Arthroscopic Surgery in Patients Treated With PAO

NCT02945995

Sponsor

Aarhus University Hospital

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

45Estimated

Phase

Not provided

Conditions

Developmental Dysplasia of the Hip

Interventions

hip arthroscopy

Countries

Not provided

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 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 2015

Primary Completion Date

Oct 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Mar 18, 2015

First Submission Date that Met QC Criteria

Oct 25, 2016

First Posted Date

Oct 26, 2016Estimated

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

Feb 21, 2017

Last Update Posted Date

Feb 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of the study is to evaluate outcome after arthroscopy if the hip in patients previous treated with periacetabular osteotomy

Detailed Description

It is well known the patients with developmental dysplasia of the hip beyond the bony malformation has intraarticular damage to labrum and chondral structures.

In DK, if the patients has persistent pain in the hip joint after PAO, they have been offered a hip arthroscopy, however we do not if their hip functions and pain improved by the surgery

The investigator aimed to make a short to middle-term followup study to see if the patients had benefits of the surgery.

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

45Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hip arthroscopy	Procedure	Follow up after hip arthroscopy in pt with previous PAO. Follow up by questionnaires send til the cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patient with the need of a total hip arthroplasty after PAO and hip arthroscopy	Questionnaire	48 months after hip arthroscopy

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the patients pain in rest and during activity on a NRS Scale	Questionnaire	48 months after hip arthroscopy
Evaluation of hip function and pain using MHHS (modified harris hip score)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

previous PAO and hip arthroscopy
developmental dysplasia of the hip

Exclusion Criteria:

calve legg perthes disease
femoral osteotomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing hip arthrocopy previous treated with periacetabular osteotomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Lind, MD,PhD,DmSc	Aarhus University Hospital	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000082602	Developmental Dysplasia of the Hip

Ancestor Terms

ID	Term
D006617	Hip Dislocation
D004204	Joint Dislocations
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided