The Analysis of Posterior Soft Tissue Repair Durability

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04490304
Collaborator
(none)
42
1
1
16.7
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: durability of posterior soft tissue repair
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
prospective randomised trialprospective randomised trial
Masking:
None (Open Label)
Masking Description:
the x-ray measurements after the surgery were done by a care provider, not by the investigator
Primary Purpose:
Treatment
Official Title:
How Durable is the Posterior Soft Tissue Repair After Total Hip Arthroplasty in Primary Osteoarthiritis Patients?
Actual Study Start Date :
Sep 4, 2018
Actual Primary Completion Date :
Oct 16, 2019
Actual Study Completion Date :
Jan 24, 2020

Arms and Interventions

Arm Intervention/Treatment
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?

Outcome Measures

Primary Outcome Measures

  1. elongation of capsular repair [6 months]

    measurement of detachment of the sutures after capsular repair

Eligibility Criteria

Criteria

Ages Eligible for Study:
41 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bakırkoysadikonuk Istanbul Bakırkoy Turkey 34150

Sponsors and Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Principal Investigator: erdem edipoglu, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT04490304
Other Study ID Numbers:
  • 2018/252
First Posted:
Jul 29, 2020
Last Update Posted:
Jul 29, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study Results

No Results Posted as of Jul 29, 2020