The Analysis of Posterior Soft Tissue Repair Durability

July 25, 2020 updated by: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

How Durable is the Posterior Soft Tissue Repair After Total Hip Arthroplasty in Primary Osteoarthiritis Patients?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total of 42 consecutive THA patients (20 women,22 men) operated for primary osteoarthritis (OA) between 2018 and 2019 were included in the study. All patients were operated by the same orthopaedic surgeon under spinal anaesthesia via posterior approach using the same type of uncemented Polar stem(Smith and Nephew Inc) with 36 mm head in combination with uncemented Ep-Fit acetabular cup (Smith and Nephew Inc). All the patients were randomly divided into two groups. The randomization process was done by the odd and even number technique in which the patients with even inpatient numbers were assigned in Group A while the odd inpatient number patients were allotted in Group B. Patients in whom number 5 Ethibond Excel(Ethicon, Somerville, NJ) were used for soft tissue repair were included in Group A (n=22), whereas patients treated with number 2 Vicryl (Ethicon, Somerville,NJ)were in Group B (n=20).

The short external rotators tendons were released from the greater trochanter just at their insertion point. The capsule was incised, but not excised. The posterior repair included reattaching the piriformis,conjoined tendons and the capsule to the greater trochanter at the insertion point through 2, 2 mm drill holes with 2 stitches with non-absorbable no.5 Ethibond suture in one group and with absorbable no 2 vicryl suture in the other group after the prosthesis had been implanted and the joint reduced. One hemoclip was attached to the piriformis tendon and another to the conjoined tendons before pulling the sutures out of the drill holes in the trochanter. The suture materials lateral to the drill holes at the trochanter were also attached with two hemoclips.(fig 1-2) The postoperative regimen included walking with full weight bearing the next day after the surgery with a walking frame and without limitations in internal rotation or flexion. Anteroposterior radiographic examination was undertaken immediately after the patients returned from the operating theatre to the intensive care unit,at the 15th day, at 3 months and 6 months postoperatively (figure 3). The detachment of the hemoclips were measured during the follow up period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bakırkoy
      • Istanbul, Bakırkoy, Turkey, 34150
        • Bakırkoysadikonuk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: posterior soft tissue repair durability
Other: durability of posterior soft tissue repair
how durable is the posterior soft tissue repair after total hip arthroplasty in primary osteoarthiritis patients?

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
elongation of capsular repair
Time Frame: 6 months
measurement of detachment of the sutures after capsular repair
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: erdem edipoglu, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 16, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/252

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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