Bursa; TuberculousNCT06553508
Trochanteric Bursal Repair After a Total Hip Replacement - Are There Benefits During the First 90 Days
A study testing Trochanteric bursa repaired and Trochanteric bursa unrepaired in people with Bursa; Tuberculous and Hip Bursitis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
During total hip arthroplasty surgery, the trochanteric bursa is routinely excised. This anatomical structure, which functions as a soft tissue barrier, is generally recommended for removal as it facilitates the surgical approach. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bursa; Tuberculous, Hip Bursitis, Deep Gluteal Syndrome
- What is being tested?
- Trochanteric bursa repaired and Trochanteric bursa unrepaired
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jan 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 to 90 years of age
- With a diagnosis of primary hip osteoarthritis
- Willing to be included in the study
Who cannot join
- Patients who had a known history of trochanteric bursitis, deep gluteal syndrome, sciatica, vertebral fracture, hip fracture, hip arthroscopy, and core decompression surgery
- Patients who had a history of bursal injection within 6 months
- Patients undergoing hip arthroplasty with a shortening osteotomy
Trial locations and contacts
1 site in 1 country.
About this study
During total hip arthroplasty surgery, the trochanteric bursa is routinely excised. This anatomical structure, which functions as a soft tissue barrier, is generally recommended for removal as it facilitates the surgical approach. However, recent studies have suggested that the trochanteric bursa is an important soft tissue barrier and may protect against infections. The aim of this study is to evaluate the differences in infection rates, wound complications, deep gluteal syndrome presence, pain, and clinical scores within the first 90 days between patients in whom the trochanteric bursa was repaired and those in whom it was not, and to provide recommendations regarding bursal repair.
Read the detailed description
During total hip arthroplasty surgery, the trochanteric bursa is routinely excised. This anatomical structure, which functions as a soft tissue barrier, is typically recommended for removal as it facilitates the surgical approach. However, recent studies have suggested that the trochanteric bursa is an important soft tissue barrier and may provide protection against infections. The aim of this study is to evaluate the differences in infection rates, wound complications, deep gluteal syndrome presence, pain, and clinical scores within the first 90 days between patients in whom the trochanteric bursa was repaired and those in whom it was not, and to provide recommendations regarding bursal repair.
This research will be a prospective randomized controlled trial with patients subjected to sequential randomization. One group of patients will undergo the routine excision of the bursa during surgery, referred to as Group 1. In the other group, the trochanteric bursa will be carefully retracted and subsequently repaired in its anatomical location beneath the fascia after the surgical procedure. Wound closure will be performed routinely, with subcutaneous and skin closure. All patients will have a Hemovac drain placed, and they will follow the same rehabilitation protocol.
Patients will be evaluated on postoperative days15, 30, and 90 using Visual Analog Scale scores, and on days 30 and 90 using the Harris Hip Score. Additionally, patients will be assessed for tenderness on palpation, the presence of hip snapping (a sensation of the hip catching), hemoglobin drop, 90-day infection rates, and the presence of deep gluteal syndrome.
- Conditions
- Bursa; Tuberculous, Hip Bursitis, Deep Gluteal Syndrome, Hip Disease
- Being tested
- Trochanteric bursa repaired, Trochanteric bursa unrepaired
- Keywords
- bursa, greater trochanter, hip arthroplasty, deep gluteal syndrome, piriformis syndrome
- Medical subject headings
- Latent Tuberculosis, Hip socket neuropathy, Piriformis Muscle Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trochanteric bursa repairedProcedure or surgery
As a routine procedure in our centre, the trochanteric bursa is left unrepaired after a hip arthroplasty.
Trochanteric bursa unrepairedProcedure or surgery
For the experimental arm, the trochanteric bursa is repaired after a hip arthroplasty. The conventional joint closure is performed after reduction and then the bursa is retrieved and repaired.
| Study group | Role | What they receive |
|---|---|---|
| Unrepaired bursa group | Active comparator | As a routine procedure in our centre, the trochanteric bursa is left unrepaired after a hip arthroplasty. The conventional joint closure is performed after reduction and the layers are closed in a routine fashion. Receives: Procedure: Trochanteric bursa unrepaired |
| Repaired Bursa group | Experimental | For the experimental arm, the trochanteric bursa is repaired after a hip arthroplasty. The conventional joint closure is performed after reduction and then the bursa is retrieved and repaired. Layers are then closed in a routine fashion. Receives: Procedure: Trochanteric bursa repaired |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of superficial wound problems
Wound leakage, superficial infection, wound dehiscence - Recorded as Yes / No
Measured: First postoperative 90 days
Rate of posterior gluteal pain
The condition is also refered to as Deep Gluteal Syndrome - Recorded as Yes / No
Measured: First postoperative 90 days
Rate of painful trochanteric bursitis
Recorded as pain on the trochanteric region on palpation - Recorded as Yes / No
Measured: First postoperative 90 days
Secondary outcomes (3)
Range of motion (ROM)
Angular measurement of hip joint motion - minimum value:0, maximum value 130, higher values mean better outcome
Measured: First postoperative 90 days
Visual Analog Scale (VAS)
minimum value:0, maximum value 10, higher values mean worse outcome
Measured: First postoperative 90 days
Harris Hip Score (HHS)
minimum value:0, maximum value 100, higher values mean better outcome
Measured: First postoperative 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bursa; TuberculousStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enejd Veizi, MD, Ankara City Hospital Bilkent
- Investigators
- Enejd Veizi, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553508
- Sponsor's protocol ID
- E2-21-1124
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwartsmann CR, Loss F, de Freitas Spinelli L, Furian R, Silva MF, Zanatta JM, Boschin LC, Goncalves RZ, Yepez AK. Association between trochanteric bursitis, osteoarthrosis and total hip arthroplasty. Rev Bras Ortop. 2014 Apr 25;49(3):267-70. doi: 10.1016/j.rboe.2014.04.009. eCollection 2014 May-Jun.
PubMed 26229811Shemesh SS, Moucha CS, Keswani A, Maher NA, Chen D, Bronson MJ. Trochanteric Bursitis Following Primary Total Hip Arthroplasty: Incidence, Predictors, and Treatment. J Arthroplasty. 2018 Apr;33(4):1205-1209. doi: 10.1016/j.arth.2017.11.016. Epub 2017 Nov 13.
PubMed 29195847Moerenhout K, Benoit B, Gaspard HS, Rouleau DM, Laflamme GY. Greater trochanteric pain after primary total hip replacement, comparing the anterior and posterior approach: A secondary analysis of a randomized trial. Orthop Traumatol Surg Res. 2021 Dec;107(8):102709. doi: 10.1016/j.otsr.2020.08.011. Epub 2020 Oct 31.
PubMed 33132093
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trochanteric Bursal Repair After a Total Hip Replacement - Are There Benefits During the First 90 Days
- ClinicalTrials.gov ID
- NCT06553508
- Acronym / sponsor ID
- E2-21-1124
- Conditions
- Bursa; Tuberculous, Hip Bursitis, Deep Gluteal Syndrome, Hip Disease
- Keywords
- bursa, greater trochanter, hip arthroplasty, deep gluteal syndrome, piriformis syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 14 Aug 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.
During total hip arthroplasty surgery, the trochanteric bursa is routinely excised. This anatomical structure, which functions as a soft tissue barrier, is generally recommended for removal as it facilitates the surgical approach. However, recent studies have suggested that the trochanteric bursa is an important soft tissue barrier and may protect against infections. The aim of this study is to evaluate the differences in infection rates, wound complications, deep gluteal syndrome presence, pain, and clinical scores within the first 90 days between patients in whom the trochanteric bursa was repaired and those in whom it was not, and to provide recommendations regarding bursal repair.
Detailed description
During total hip arthroplasty surgery, the trochanteric bursa is routinely excised. This anatomical structure, which functions as a soft tissue barrier, is typically recommended for removal as it facilitates the surgical approach. However, recent studies have suggested that the trochanteric bursa is an important soft tissue barrier and may provide protection against infections. The aim of this study is to evaluate the differences in infection rates, wound complications, deep gluteal syndrome presence, pain, and clinical scores within the first 90 days between patients in whom the trochanteric bursa was repaired and those in whom it was not, and to provide recommendations regarding bursal repair.
This research will be a prospective randomized controlled trial with patients subjected to sequential randomization. One group of patients will undergo the routine excision of the bursa during surgery, referred to as Group 1. In the other group, the trochanteric bursa will be carefully retracted and subsequently repaired in its anatomical location beneath the fascia after the surgical procedure. Wound closure will be performed routinely, with subcutaneous and skin closure. All patients will have a Hemovac drain placed, and they will follow the same rehabilitation protocol.
Patients will be evaluated on postoperative days15, 30, and 90 using Visual Analog Scale scores, and on days 30 and 90 using the Harris Hip Score. Additionally, patients will be assessed for tenderness on palpation, the presence of hip snapping (a sensation of the hip catching), hemoglobin drop, 90-day infection rates, and the presence of deep gluteal syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Unrepaired bursa group | Active comparator | Procedure: Trochanteric bursa unrepairedAs a routine procedure in our centre, the trochanteric bursa is left unrepaired after a hip arthroplasty. The conventional joint closure is performed after reduction and the layers are closed in a routine fashion. |
| Repaired Bursa group | Experimental | Procedure: Trochanteric bursa repairedFor the experimental arm, the trochanteric bursa is repaired after a hip arthroplasty. The conventional joint closure is performed after reduction and then the bursa is retrieved and repaired. Layers are then closed in a routine fashion. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between 18 to 90 years of age
- With a diagnosis of primary hip osteoarthritis
- Willing to be included in the study
Key exclusion criteria (3 listed)
- Patients who had a known history of trochanteric bursitis, deep gluteal syndrome, sciatica, vertebral fracture, hip fracture, hip arthroscopy, and core decompression surgery
- Patients who had a history of bursal injection within 6 months
- Patients undergoing hip arthroplasty with a shortening osteotomy
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 |
|---|---|---|
| Trochanteric bursa repairedAs a routine procedure in our centre, the trochanteric bursa is left unrepaired after a hip arthroplasty. | Procedure or surgery | Repaired Bursa group |
| Trochanteric bursa unrepairedFor the experimental arm, the trochanteric bursa is repaired after a hip arthroplasty. The conventional joint closure is performed after reduction and then the bursa is retrieved and repaired. | Procedure or surgery | Unrepaired bursa group |
Primary outcome
Rate of superficial wound problems
Time frame: First postoperative 90 days
Wound leakage, superficial infection, wound dehiscence - Recorded as Yes / No
Rate of posterior gluteal pain
Time frame: First postoperative 90 days
The condition is also refered to as Deep Gluteal Syndrome - Recorded as Yes / No
Rate of painful trochanteric bursitis
Time frame: First postoperative 90 days
Recorded as pain on the trochanteric region on palpation - Recorded as Yes / No
3 secondary outcomes
Range of motion (ROM)
Time frame: First postoperative 90 days
Visual Analog Scale (VAS)
Time frame: First postoperative 90 days
Harris Hip Score (HHS)
Time frame: First postoperative 90 days
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 16 Aug 2024.
- Background: PubMed 26229811Schwartsmann CR, Loss F, de Freitas Spinelli L, Furian R, Silva MF, Zanatta JM, Boschin LC, Goncalves RZ, Yepez AK. Association between trochanteric bursitis, osteoarthrosis and total hip arthroplasty. Rev Bras Ortop. 2014 Apr 25;49(3):267-70. doi: 10.1016/j.rboe.2014.04.009. eCollection 2014 May-Jun.
- Background: PubMed 29195847Shemesh SS, Moucha CS, Keswani A, Maher NA, Chen D, Bronson MJ. Trochanteric Bursitis Following Primary Total Hip Arthroplasty: Incidence, Predictors, and Treatment. J Arthroplasty. 2018 Apr;33(4):1205-1209. doi: 10.1016/j.arth.2017.11.016. Epub 2017 Nov 13.
- Background: PubMed 33132093Moerenhout K, Benoit B, Gaspard HS, Rouleau DM, Laflamme GY. Greater trochanteric pain after primary total hip replacement, comparing the anterior and posterior approach: A secondary analysis of a randomized trial. Orthop Traumatol Surg Res. 2021 Dec;107(8):102709. doi: 10.1016/j.otsr.2020.08.011. Epub 2020 Oct 31.
- Individual participant dataSharing planned: No
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.
Enejd Veizi, MD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trochanteric bursa repaired and Trochanteric bursa unrepaired in people with Bursa; Tuberculous and Hip Bursitis, run by Ankara City Hospital Bilkent 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 3 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 16 Aug 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 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?
Rate of superficial wound problems (time frame: First postoperative 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06553508, which also lists 3 linked publications.
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 16 Aug 2024.