Evaluation of Return to Sports Activity After Periacetabu... | NCT07590882

Studies
Evaluation of Return to Sports Activity After Periacetabular Osteotomy: An Observational Study

NCT07590882

Sponsor

Istituto Ortopedico Rizzoli

Status

Enrolling by invitation

Last Update Posted

May 15, 2026Actual

Enrollment

26Estimated

Phase

Not provided

Conditions

Hip Surgeries
Hip Developmental Dysplasia

Interventions

Correction Factor

Countries

Italy

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

May 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2025Actual

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Jan 1, 2027Estimated

First Submitted Date

Apr 30, 2026

First Submission Date that Met QC Criteria

May 12, 2026

First Posted Date

May 15, 2026Actual

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

May 12, 2026

Last Update Posted Date

May 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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 study aims to collect datas about patient who underwent periacetabular osteotomy

Detailed Description

The aim of the study is to understant the long term effet of the periacetabular osteotomy in terms of pain relief, patient satisfaction and ability to return to sports

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

26Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient undergoing periacetabular osteootmy		patient undergoing periacetabular osteootmy	Procedure: Correction Factor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Correction Factor	Procedure	periacetabular osteotomy	patient undergoing periacetabular osteootmy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
return to sport	The percentage of patients who return to their preoperative sports activity	follow-up of 6 months

Secondary Outcomes

Measure	Description	Time Frame
failure rate	determine the failure rate of PAO during follow-up	follow-up of 6 months
level of pain post operative	Pain assessment using the Visual Analog Scale (VAS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of both sexes who underwent periacetabular osteotomy (PAO) at the sites of the Istituto Ortopedico Rizzoli (IOR) in Bologna (CORTI), Argenta, and Bagheria between 2017 and March 2025
Postoperative follow-up ≥ 6 months
Complete clinical and radiographic documentation available for retrospective analysis
Willingness to participate in the study
Age at the time of surgery between 12 and 40 years

Exclusion Criteria:

Patients unable to provide informed consent, unable to understand and decide, or minors whose parents/legal guardians do not provide informed consent
Patients with previous or ongoing oncological diseases, if associated with a potential impact on joint function or bone healing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

patients undergoing periacetabular osteotomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Istituto Ortopedico Rizzoli		Bologna		40136	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

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