NCT04490304

Brief Summary

Dislocation after THA usually occurs early after surgery and some go on to disabling recurrent dislocations . The posterior surgical approach is frequently used since it provides excellent exposure of both acetabulum and femur. However, many series on primary THA have reported that dislocation is 2 to 3 times more frequent after the posterior approach as compared to other approaches . Dissatisfaction with these dislocation rates resulted in the introduction of different posterior soft tissue repair techniques. Many authors have reported statistically significant differences in dislocation rates with posterior soft tissue repair as compared to without . However, there is still a concern in the literature regarding the durability of posterior soft tissue repair. The aim of our study was to analyse THA patients with posterior soft tissue repair in terms of suture durability of two different suture materials and time of suture failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 4, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

July 25, 2020

Last Update Submit

July 25, 2020

Conditions

Arthroplasty Complications

Keywords

posterior soft tissue repair

Outcome Measures

Primary Outcomes (1)

  • elongation of capsular repair

    measurement of detachment of the sutures after capsular repair

    6 months

Study Arms (1)

posterior soft tissue repair durability

OTHER
Other: durability of posterior soft tissue repair

Interventions

durability of posterior soft tissue repairOTHER

how durable is the posterior soft tissue repair after total hip arthroplasty in primary osteoarthiritis patients?

posterior soft tissue repair durability

Eligibility Criteria

Age41 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary osteoarthritis patients between 40-80 years old undergoing total hip replacement surgery between 2018-2019

You may not qualify if:

  • Any type of secondary osteoarthritis patients, and patients younger than 40 and older than 80 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırkoysadikonuk

Istanbul, Bakırkoy, 34150, Turkey (Türkiye)

Location

Study Officials

  • erdem edipoglu

    Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
the x-ray measurements after the surgery were done by a care provider, not by the investigator
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective randomised trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2020

First Posted

July 29, 2020

Study Start

September 4, 2018

Primary Completion

October 16, 2019

Study Completion

January 24, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

TU(1)