Suture, ComplicationNCT06675968
Evaluating the Need for Transosseous Anchoring in Anterolateral Hip Prosthetic Surgery
A study testing Direct Suture and Transosseus Suture in people with Suture, Complication, run by Mireia Vinas Noguera at 1 site in Spain.
Trial summary
The study aims to discuss the challenges associated with breakage or failure of the abductor mechanism after total hip arthroplasty, which can lead to gait issues, instability, and the need for revision surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Suture, Complication
- What is being tested?
- Direct Suture and Transosseus Suture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2022to 12 Dec 2023
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult population
- Patients diagnosed with coxarthrosis (stages 2 and 3), confirmed by X-ray, according to D. Tonnis's classification of 1972
- Willingness to follow up for up to 12 months
- Patients capable of understanding the study and giving their informed consent
Who cannot join
- Difficulty understanding and following the study procedure
- Patients with previous surgery on the same hip
- Patients with a diagnosis other than the inclusion criteria (e.g. acute femoral fracture requiring total hip arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Prospective, Single-blind Controlled Clinical Trial to Systematically Assess the Need for Transosseous Anchoring in the Anterolateral Approach to Primary Hip Prosthetic Surgery
The study aims to discuss the challenges associated with breakage or failure of the abductor mechanism after total hip arthroplasty, which can lead to gait issues, instability, and the need for revision surgery. Sutures play a crucial role in preventing these failures, with two main types: transosseous and tendon sutures. Transosseous suturing involves using non-absorbable threads anchored in the bone, while tendon suturing uses absorbable threads for layered closure.
Both techniques are commonly used, but there is a lack of evidence to determine which is more beneficial for patients. Current studies are limited and often focus on cases requiring revision surgery due to complications, with transosseous sutures generally being the preferred method.
A meta-analysis indicated that transosseous repair may result in lower dislocation rates and less postoperative pain, but further randomized clinical trials with long-term follow-up are necessary for definitive conclusions. The text proposes a prospective study to compare transosseous suturing with the common absorbable tendon suturing in primary hip surgeries.
- Conditions
- Suture, Complication
- Being tested
- Direct Suture, Transosseus Suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct SutureProcedure or surgery
A capsular closure will be performed, closure of the gluteus medius with a direct tendon and absorbable suture. Addittionally, the iliotibial band, subcutaneous and skin suture closure will be performed.
Transosseus SutureProcedure or surgery
A capsular closure will be performed, transosseous suture with a non-absorbable suture. Addittionally, the iliotibial band, subcutaneous and skin suture closure will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Direct suture | Experimental | Not described Receives: Procedure: Direct Suture |
| Transsosseus suture | Experimental | Not described Receives: Procedure: Transosseus Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trendelenburg Test
It evaluates the paradoxical elevation of the pelvis in monopodal support on the observed limb. It suggests insufficiency or rupture of the abductor apparatus. It can be positive (+), that is, suggesting abductor pathology, or negative (-), that is, suggesting the absence of a clinical problem in that segment. This is a clinical test that is usually performed during preoperative and follow-up visits to the patient and does not present any risks for the patient. It is performed with the patient standing with body weight evenly distributed. The examiner stands behind the patient and identifies the iliac crests and posterior superior iliac spine. The patient raises the leg that is contralateral to the side being evaluated.
Measured: preoperative and 3 months
Secondary outcomes (6)
Pain Level
Pain levels, assessed with a visual analogue scale (VAS) from 0 to 10, with 0 being no pain and 10 being the maximum bearable pain.
Measured: Preoperative at 24 and 48 hours and postoperative at 3, 6 and 12 months
Quality of life
Functionality and quality of life are assessed with the Harris Hip Score questionnaire (questionnaire on functionality, quality of life, limp, mobility, deformity). This functional test is approved by the International Society of Hip Surgery (Harris Hip Score)
Measured: Preoperative, 3, 6 and 12 months.
Surgeons sensation
Score 1-3, 1 suture stability, 2 partial stability, 3 sensation of instability.
Measured: 3 and 12 months
Patient Satisfaction
Questionnaire with 5 possible and gradual responses, from zero to complete satisfaction.
Measured: 3 and 12 months
Complications
Determine the presence and, where appropriate, the type.
Measured: Up to 1 year
Complementary tests
In the case of a positive Trendelenburg test, the integrity of the abductor apparatus and motor innervation can be studied. Ultrasound is a non-invasive test usually performed in the case of clinical suspicion of abductor apparatus insufficiency. Electromyography is a non-invasive test, performed using surface electrodes, which assesses the functionality of the superior gluteal nerve, responsible for innervation of the gluteus medius muscle, usually requested in the case of suspicion of the abductor apparatus.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start2 May 2022
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suture, ComplicationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mireia Vinas Noguera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mireia Vinas Noguera, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675968
- Sponsor's protocol ID
- Gluteus Medius
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2024
- Last updated
- 6 Nov 2024
- 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 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Single-blind Controlled Clinical Trial to Systematically Assess the Need for Transosseous Anchoring in the Anterolateral Approach to Primary Hip Prosthetic Surgery
- ClinicalTrials.gov ID
- NCT06675968
- Acronym / sponsor ID
- Gluteus Medius
- Conditions
- Suture, Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Mireia Vinas NogueraUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 6 Nov 2024 (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.
The study aims to discuss the challenges associated with breakage or failure of the abductor mechanism after total hip arthroplasty, which can lead to gait issues, instability, and the need for revision surgery. Sutures play a crucial role in preventing these failures, with two main types: transosseous and tendon sutures. Transosseous suturing involves using non-absorbable threads anchored in the bone, while tendon suturing uses absorbable threads for layered closure.
Both techniques are commonly used, but there is a lack of evidence to determine which is more beneficial for patients. Current studies are limited and often focus on cases requiring revision surgery due to complications, with transosseous sutures generally being the preferred method.
A meta-analysis indicated that transosseous repair may result in lower dislocation rates and less postoperative pain, but further randomized clinical trials with long-term follow-up are necessary for definitive conclusions. The text proposes a prospective study to compare transosseous suturing with the common absorbable tendon suturing in primary hip surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct suture | Experimental | Procedure: Direct Suture |
| Transsosseus suture | Experimental | Procedure: Transosseus Suture |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult population
- Patients diagnosed with coxarthrosis (stages 2 and 3), confirmed by X-ray, according to D. Tonnis's classification of 1972
- Willingness to follow up for up to 12 months
- Patients capable of understanding the study and giving their informed consent
Key exclusion criteria (3 listed)
- Difficulty understanding and following the study procedure
- Patients with previous surgery on the same hip
- Patients with a diagnosis other than the inclusion criteria (e.g. acute femoral fracture requiring total hip arthroplasty
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 |
|---|---|---|
| Direct SutureA capsular closure will be performed, closure of the gluteus medius with a direct tendon and absorbable suture. Addittionally, the iliotibial band, subcutaneous and skin suture closure will be performed. | Procedure or surgery | Direct suture |
| Transosseus SutureA capsular closure will be performed, transosseous suture with a non-absorbable suture. Addittionally, the iliotibial band, subcutaneous and skin suture closure will be performed. | Procedure or surgery | Transsosseus suture |
Primary outcome
Trendelenburg Test
Time frame: preoperative and 3 months
It evaluates the paradoxical elevation of the pelvis in monopodal support on the observed limb. It suggests insufficiency or rupture of the abductor apparatus. It can be positive (+), that is, suggesting abductor pathology, or negative (-), that is, suggesting the absence of a clinical problem in that segment. This is a clinical test that is usually performed during preoperative and follow-up visits to the patient and does not present any risks for the patient. It is performed with the patient standing with body weight evenly distributed. The examiner stands behind the patient and identifies the iliac crests and posterior superior iliac spine. The patient raises the leg that is contralateral to the side being evaluated.
6 secondary outcomes
Pain Level
Time frame: Preoperative at 24 and 48 hours and postoperative at 3, 6 and 12 months
Quality of life
Time frame: Preoperative, 3, 6 and 12 months.
Surgeons sensation
Time frame: 3 and 12 months
Patient Satisfaction
Time frame: 3 and 12 months
Complications
Time frame: Up to 1 year
Complementary tests
Time frame: Up to 1 year
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 6 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Suture and Transosseus Suture in people with Suture, Complication, run by Mireia Vinas Noguera at 1 site in Spain.
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 4 inclusion and 3 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 6 Nov 2024. 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 Spain. 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?
Trendelenburg Test (time frame: preoperative and 3 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 6 Nov 2024.