Arthroplasty ComplicationsNCT04490304
The Analysis of Posterior Soft Tissue Repair Durability
A study testing durability of posterior soft tissue repair in people with Arthroplasty Complications, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 41 to 79 years
- Conditions the study is for
- Arthroplasty Complications
- What is being tested?
- durability of posterior soft tissue repair
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2018to 24 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary osteoarthritis patients between 40-80 years old undergoing total hip replacement surgery between 2018-2019
Who cannot join
- Any type of secondary osteoarthritis patients, and patients younger than 40 and older than 80 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthroplasty Complications
- Being tested
- durability of posterior soft tissue repair
- Keywords
- posterior soft tissue repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
durability of posterior soft tissue repairOther
how durable is the posterior soft tissue repair after total hip arthroplasty in primary osteoarthiritis patients?
| Study group | Role | What they receive |
|---|---|---|
| posterior soft tissue repair durability | Other | Not described Receives: Other: durability of posterior soft tissue repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
elongation of capsular repair
measurement of detachment of the sutures after capsular repair
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start4 Sep 2018
- Primary completion16 Oct 2019
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective randomised trial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- erdem edipoglu, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490304
- Sponsor's protocol ID
- 2018/252
- Status last verified
- Jul 2020
- First submitted
- 25 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Durable is the Posterior Soft Tissue Repair After Total Hip Arthroplasty in Primary Osteoarthiritis Patients?
- ClinicalTrials.gov ID
- NCT04490304
- Acronym / sponsor ID
- 2018/252
- Conditions
- Arthroplasty Complications
- Keywords
- posterior soft tissue repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective randomised trial
| Arm | Type | Receives |
|---|---|---|
| posterior soft tissue repair durability | Other | Other: durability of posterior soft tissue repair |
Who may qualify
- Ages
- 41 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary osteoarthritis patients between 40-80 years old undergoing total hip replacement surgery between 2018-2019
Key exclusion criteria (1 listed)
- Any type of secondary osteoarthritis patients, and patients younger than 40 and older than 80 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| durability of posterior soft tissue repairhow durable is the posterior soft tissue repair after total hip arthroplasty in primary osteoarthiritis patients? | Other | posterior soft tissue repair durability |
Primary outcome
elongation of capsular repair
Time frame: 6 months
measurement of detachment of the sutures after capsular repair
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
erdem edipoglu principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing durability of posterior soft tissue repair in people with Arthroplasty Complications, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
elongation of capsular repair (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.