- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04490304
The Analysis of Posterior Soft Tissue Repair Durability
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bakırkoy
-
Istanbul, Bakırkoy, Turkey, 34150
- Bakırkoysadikonuk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
---|---|
Other: posterior soft tissue repair durability
|
how durable is the posterior soft tissue repair after total hip arthroplasty in primary osteoarthiritis patients?
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- Principal Investigator: erdem edipoglu, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2018/252
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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