Hip Prosthesis InfectionNCT03161990
DAIR for Infected Total Hip Arthroplasty - Does the Operative Approach Influence the Functional Result?
An observational study of Hip Prosthesis Infection and Arthroplasty Complications, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The functional outcome and quality of life after treatment for an infected hip arthroplasty have been found to be significantly worse compared to an uncomplicated arthroplasty. However, the type of revision surgery chosen to treat the infection plays a role for the functional outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Prosthesis Infection, Arthroplasty Complications
- What is being tested?
- Transgluteal approach to the hip joint and Posterior approach to the hip joint
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 226 participants
- Where
- 1 siteNorway
- Study dates
- 23 Apr 2018to 17 Nov 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The potential study participant will be identified in the Norwegian Arthroplasty Register.
Who may be able to join
- The infected total hip arthroplasty has only been revised once.
- The revision procedure was a debridement and implant retention.
- Both, the primary and the revision procedure were performed through the same surgical approach; either the transgluteal or the posterior approach.
Who cannot join
- No written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Debridement, Antibiotics and Implant Retention (DAIR) for Infected Total Hip Arthroplasty- Does the Operative Approach Influence the Functional Result?
The functional outcome and quality of life after treatment for an infected hip arthroplasty have been found to be significantly worse compared to an uncomplicated arthroplasty. However, the type of revision surgery chosen to treat the infection plays a role for the functional outcome. The concept of DAIR (debridement, antibiotics and implant retention) has been shown to yield god results with respect to infection control in cases of early infection with a stable implant and better functional results than a to-stage revision. In patients where infection control was achieved after just one DAIR procedure the functional outcome was comparable to an uncomplicated primary arthroplasty. However, it is not known if the operative approach used for the primary and revision surgery plays a role for the functional result after treatment of an infected total hip arthroplasty with DAIR. The project's aim is to investigate if the choice of the operative approach (transgluteal or posterior) for the primary hip replacement and the revision surgery has an influence on the functional result after debridement and implant retention for an infected total hip replacement.
Read the detailed description
Potential study participants will be identified in the Norwegian Arthroplasty Register. Patients who have been revised once for an infected total hip arthroplasty with debridement and implant retention and in whom either the transgluteal og posterior operative approach was used in both procedures will be selected. The potential participants will be contacted by letter. They will be asked for written informed consent and to fill out three questionnaires: the Hip Disability Osteoarthritis Score (HOOS), which also allows for the calculation of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), the EQ-5D (quality of life) and a questionnaire asking about confirmation that the patient only has been revised once for his/her infected arthroplasty, about limping, other complications (nerve injury, dislocation, reoperation for other causes than infection), if the infection is considered to have been eradicated and overall satisfaction. The data recorded in the Norwegian Arthroplasty Register will be used in a multiple linear regression analysis to evaluate if the surgical approach is an independent factor influencing the outcome measures.
- Being tested
- Transgluteal approach to the hip joint, Posterior approach to the hip joint
- Keywords
- DAIR, Transgluteal approach, Posterior approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transgluteal approach to the hip jointProcedure or surgery
Also called Direct lateral approach to the hip joint
Operative approach to the hip joint where the abductors are partly detached from the greater trochanter and the hip joint is approached through the anterior part of the capsule.
Posterior approach to the hip jointProcedure or surgery
Also called Posterolateral approach to the hip joint
Operative approach to the hip joint where the short external rotators are detached from the greater trochanter and the hip joint is approached through the posterior part of the capsule.
| Study group | Role | What they receive |
|---|---|---|
| Transgluteal approach to the hip joint | Patients who have been revised once for an infected total hip replacement with debridement and implant retention and in whom both the primary hip arthroplasty and the revision procedure were performed through a transgluteal approach. Receives: Procedure: Transgluteal approach to the hip joint | |
| Posterior approach to the hip joint | Patients who have been revised once for an infected total hip replacement with debridement and implant retention and in whom both the primary hip arthroplasty and the revision procedure were performed through a posterior approach. Receives: Procedure: Posterior approach to the hip joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function subscale score of the WOMAC
Function subscale score of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC)
Measured: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Secondary outcomes (6)
WOMAC score
Western Ontario and McMaster Universities osteoarthritis index score
Measured: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
HOOS
Hip Disability Osteoarthritis Score
Measured: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
EQ-5D score
Quality of life score
Measured: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Limping
Patient reported limping on the side of the revised total hip replacement.
Measured: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Other complications
Patient reported nerve injury, dislocation, reoperation for other causes than infection.
Measured: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Overall satisfaction
Overall satisfaction with the revised total hip replacement assessed by questionnaire.
Measured: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start23 Apr 2018
- Primary completion17 Nov 2018
- Study completion17 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hip Prosthesis InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Principal investigator, Asbjorn Aroen, University Hospital, Akershus
- Investigators
- Asbjorn Aaroen, Professor, Study director, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161990
- Sponsor's protocol ID
- 287901
- Status last verified
- Jun 2019
- First submitted
- 15 May 2017
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cahill JL, Shadbolt B, Scarvell JM, Smith PN. Quality of life after infection in total joint replacement. J Orthop Surg (Hong Kong). 2008 Apr;16(1):58-65. doi: 10.1177/230949900801600115.
PubMed 18453662Byren I, Bejon P, Atkins BL, Angus B, Masters S, McLardy-Smith P, Gundle R, Berendt A. One hundred and twelve infected arthroplasties treated with 'DAIR' (debridement, antibiotics and implant retention): antibiotic duration and outcome. J Antimicrob Chemother. 2009 Jun;63(6):1264-71. doi: 10.1093/jac/dkp107. Epub 2009 Mar 31.
PubMed 19336454Grammatopoulos G, Kendrick B, McNally M, Athanasou NA, Atkins B, McLardy-Smith P, Taylor A, Gundle R. Outcome Following Debridement, Antibiotics, and Implant Retention in Hip Periprosthetic Joint Infection-An 18-Year Experience. J Arthroplasty. 2017 Jul;32(7):2248-2255. doi: 10.1016/j.arth.2017.02.066. Epub 2017 Mar 6.
PubMed 28385345Pollmann CT, Gjertsen JE, Dale H, Straume-Naesheim TM, Dybvik E, Hallan G. Operative approach influences functional outcome after DAIR for infected total hip arthroplasty. Bone Joint J. 2020 Dec;102-B(12):1662-1669. doi: 10.1302/0301-620X.102B12.BJJ-2020-0501.R1.
PubMed 33249901
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Debridement, Antibiotics and Implant Retention (DAIR) for Infected Total Hip Arthroplasty- Does the Operative Approach Influence the Functional Result?
- ClinicalTrials.gov ID
- NCT03161990
- Acronym / sponsor ID
- 287901
- Keywords
- DAIR, Transgluteal approach, Posterior approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 17 Nov 2018 (actual)
- Study completion
- 17 Nov 2018 (actual)
- First posted
- 22 May 2017 (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 functional outcome and quality of life after treatment for an infected hip arthroplasty have been found to be significantly worse compared to an uncomplicated arthroplasty. However, the type of revision surgery chosen to treat the infection plays a role for the functional outcome. The concept of DAIR (debridement, antibiotics and implant retention) has been shown to yield god results with respect to infection control in cases of early infection with a stable implant and better functional results than a to-stage revision. In patients where infection control was achieved after just one DAIR procedure the functional outcome was comparable to an uncomplicated primary arthroplasty. However, it is not known if the operative approach used for the primary and revision surgery plays a role for the functional result after treatment of an infected total hip arthroplasty with DAIR. The project's aim is to investigate if the choice of the operative approach (transgluteal or posterior) for the primary hip replacement and the revision surgery has an influence on the functional result after debridement and implant retention for an infected total hip replacement.
Detailed description
Potential study participants will be identified in the Norwegian Arthroplasty Register. Patients who have been revised once for an infected total hip arthroplasty with debridement and implant retention and in whom either the transgluteal og posterior operative approach was used in both procedures will be selected. The potential participants will be contacted by letter. They will be asked for written informed consent and to fill out three questionnaires: the Hip Disability Osteoarthritis Score (HOOS), which also allows for the calculation of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), the EQ-5D (quality of life) and a questionnaire asking about confirmation that the patient only has been revised once for his/her infected arthroplasty, about limping, other complications (nerve injury, dislocation, reoperation for other causes than infection), if the infection is considered to have been eradicated and overall satisfaction. The data recorded in the Norwegian Arthroplasty Register will be used in a multiple linear regression analysis to evaluate if the surgical approach is an independent factor influencing the outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transgluteal approach to the hip joint | – | Procedure: Transgluteal approach to the hip jointPatients who have been revised once for an infected total hip replacement with debridement and implant retention and in whom both the primary hip arthroplasty and the revision procedure were performed through a transgluteal approach. |
| Posterior approach to the hip joint | – | Procedure: Posterior approach to the hip jointPatients who have been revised once for an infected total hip replacement with debridement and implant retention and in whom both the primary hip arthroplasty and the revision procedure were performed through a posterior approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The potential study participant will be identified in the Norwegian Arthroplasty Register.
Key inclusion criteria (3 listed)
- The infected total hip arthroplasty has only been revised once.
- The revision procedure was a debridement and implant retention.
- Both, the primary and the revision procedure were performed through the same surgical approach; either the transgluteal or the posterior approach.
Key exclusion criteria (1 listed)
- No written informed consent.
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 |
|---|---|---|
| Transgluteal approach to the hip jointAlso: Direct lateral approach to the hip jointOperative approach to the hip joint where the abductors are partly detached from the greater trochanter and the hip joint is approached through the anterior part of the capsule. | Procedure or surgery | Transgluteal approach to the hip joint |
| Posterior approach to the hip jointAlso: Posterolateral approach to the hip jointOperative approach to the hip joint where the short external rotators are detached from the greater trochanter and the hip joint is approached through the posterior part of the capsule. | Procedure or surgery | Posterior approach to the hip joint |
Primary outcome
Function subscale score of the WOMAC
Time frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Function subscale score of the Western Ontario and McMaster Universities osteoarthritis index (WOMAC)
6 secondary outcomes
WOMAC score
Time frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
HOOS
Time frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
EQ-5D score
Time frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Limping
Time frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Other complications
Time frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
Overall satisfaction
Time frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure
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 18 Jun 2019.
- Background: PubMed 18453662Cahill JL, Shadbolt B, Scarvell JM, Smith PN. Quality of life after infection in total joint replacement. J Orthop Surg (Hong Kong). 2008 Apr;16(1):58-65. doi: 10.1177/230949900801600115.
- Background: PubMed 19336454Byren I, Bejon P, Atkins BL, Angus B, Masters S, McLardy-Smith P, Gundle R, Berendt A. One hundred and twelve infected arthroplasties treated with 'DAIR' (debridement, antibiotics and implant retention): antibiotic duration and outcome. J Antimicrob Chemother. 2009 Jun;63(6):1264-71. doi: 10.1093/jac/dkp107. Epub 2009 Mar 31.
- Background: PubMed 28385345Grammatopoulos G, Kendrick B, McNally M, Athanasou NA, Atkins B, McLardy-Smith P, Taylor A, Gundle R. Outcome Following Debridement, Antibiotics, and Implant Retention in Hip Periprosthetic Joint Infection-An 18-Year Experience. J Arthroplasty. 2017 Jul;32(7):2248-2255. doi: 10.1016/j.arth.2017.02.066. Epub 2017 Mar 6.
- Derived from this study: PubMed 33249901Pollmann CT, Gjertsen JE, Dale H, Straume-Naesheim TM, Dybvik E, Hallan G. Operative approach influences functional outcome after DAIR for infected total hip arthroplasty. Bone Joint J. 2020 Dec;102-B(12):1662-1669. doi: 10.1302/0301-620X.102B12.BJJ-2020-0501.R1.
- Individual participant dataSharing planned: No
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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.
Asbjorn Aaroen, Professor study director
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Prosthesis Infection and Arthroplasty Complications, run by University Hospital, Akershus at 1 site in Norway.
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 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 18 Jun 2019. 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 Norway. 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?
Function subscale score of the WOMAC (time frame: At minimum 1 year, on average 5 year follow-up from the DAIR procedure). 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 NCT03161990, which also lists 4 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 18 Jun 2019.