NCT06365112

Brief Summary

Try to develop an endoscopic surgical technique to treat acetabulum fractures

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at P25-P50 for early_phase_1

Timeline
20mo left

Started Apr 2024

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Apr 2024Jan 2028

Study Start

First participant enrolled

April 1, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

April 10, 2024

Last Update Submit

April 19, 2024

Conditions

Acetabulum Fracture

Keywords

acetabulum fractureEndoscopyMinimal invasivecollaboration

Outcome Measures

Primary Outcomes (4)

  • Number of patients with major complications

    At three months

  • Number of patients with minor complications

    At three months

  • Operation time

    Intraoperative

  • Patient satisfaction using EQ5D

    through study completion, an average of 1 year

Study Arms (2)

Endoscopic assisted acetabulum fractrure treatment

ACTIVE COMPARATOR
Procedure: Endoscopy assisted

Open reduction

ACTIVE COMPARATOR
Procedure: Endoscopy assisted

Interventions

Endoscopy assistedPROCEDURE

Endoscopy

Endoscopic assisted acetabulum fractrure treatmentOpen reduction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acetabulum fracture

You may not qualify if:

  • \<18years
  • Previous lower abdominal operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University hospital

Tampere, 33521, Finland

RECRUITING

Central Study Contacts

Piia Suomalainen

CONTACT

+3583311611piia.suomalainen@pirha.fi

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 15, 2024

Study Start

April 1, 2024

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

April 24, 2024

Record last verified: 2024-04

Locations

FI(1)