Loosening, ProsthesisNCT05508958
Cup Revisions Through Anterior or Posterolateral Approach: an RCT
A study testing Anterior approach and Posterolateral approach in people with Loosening, Prosthesis, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
Trial summary
With increasing numbers of total hip arthroplasties performed each year, the incidence of problems related to loosening and wear of total hip arthroplasties is expected to also increase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loosening, Prosthesis
- What is being tested?
- Anterior approach and Posterolateral approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Sep 2022to Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- On waiting list or scheduled for isolated cup revision surgery through anterior or posterolateral approach
- A good command of the Dutch language
Who cannot join
- Revision for confirmed or suspected infection
- Not suitable for both approaches under study, as judged by orthopaedic surgeon
- Unable to fully understand study information and to accurately/reliably complete the questionnaires, as judged by researcher and/or orthopaedic surgeon
- Unable to accurately follow instructions for study procedures / measurements, as judged by researcher and/or orthopaedic surgeon
- Unwilling to sign informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimising Recovery After Cup Revision - is the Anterior Approach Superior to Posterolateral?
With increasing numbers of total hip arthroplasties performed each year, the incidence of problems related to loosening and wear of total hip arthroplasties is expected to also increase. While the anterior approach for primary total hip arthroplasty has demonstrated to result in a faster short-term recovery than the traditional lateral and posterior approach, this effect has not yet been investigated in revision surgery. Accelerating functional outcome may increase patient satisfaction and reduce healthcare costs.
The primary objective is to assess whether isolated cup revision surgery through the anterior approach results in increased functional status and higher patient satisfaction than through the posterolateral approach.
Read more
This is a prospective Randomized Controlled Trial (RCT) in which 68 patients will be included (34 per group). Patients will be evaluated preoperatively and 6 weeks, 3 months and 1 year postoperatively.
The main endpoints are functional recovery as measured with the 30-sec Chair Stand Test (30s-CST), 40m Fast Paced Walking Test (40m FPWT) and the Stair Climb Test (SCT).
Secondary endpoints are Modified Borg scale outcomes after the functional tests, Numeric Rating Scale (NRS) for pain (rest/movement), Oxford Hip Score (OHS), HOOS-PS, EQ-5D-5L, satisfaction, cup inclination and complications at 30 days and 90 days postoperatively.
- Conditions
- Loosening, Prosthesis
- Being tested
- Anterior approach, Posterolateral approach
- Keywords
- Isolated cup revision, Hip revision surgery, Anterior approach, Posterolateral approach, Cup revision surgery
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior approachProcedure or surgery
Anterior approach
Posterolateral approachProcedure or surgery
Posterolateral approach
| Study group | Role | What they receive |
|---|---|---|
| Anterior approach | Experimental | Cup revision surgery through the anterior approach Receives: Procedure: Anterior approach |
| Posterolateral approach | Active comparator | Cup revision surgery through the posterolateral approach Receives: Procedure: Posterolateral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks
The 30 second Chair Stand Test (30s-CST) is designed to test the sit-to-stand activity, incorporating lower body strength and dynamic balance, and measures the maximum number of chair stand repetitions possible in a 30 second period. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Measured: 6 weeks postoperatively
Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks
The 40m Fast Paced Walk Test (40m FPWT) tests walking speed over short distances and changing directions during walking. It is timed over 4 x 10 meters, for a total of 40 meters. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Measured: 6 weeks postoperatively
Change from baseline Stair Climb Test (SCT) at 6 weeks
The Stair Climb Test (SCT) is designed to test ascending and descending stair activity, and measures the time in seconds to ascend and descend a flight of stairs. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Measured: 6 weeks postoperatively
Secondary outcomes (14)
Change from baseline Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 30s-CST at 6 weeks, 3 months and 1 year
We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks
Measured: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 40m FPWT at 6 weeks, 3 months and 1 year
We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks
Measured: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during SCT at 6 weeks, 3 months and 1 year
We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks
Measured: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks, 3 months and 1 year
The 30 second Chair Stand Test (30s-CST) is designed to test the sit-to-stand activity, incorporating lower body strength and dynamic balance, and measures the maximum number of chair stand repetitions possible in a 30 second period. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Measured: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks, 3 months and 1 year
The 40m Fast Paced Walk Test (40m FPWT) tests walking speed over short distances and changing directions during walking. It is timed over 4 x 10 meters, for a total of 40 meters. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Measured: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
Change from baseline Stair Climb Test (SCT) at 6 weeks, 3 months and 1 year
The Stair Climb Test (SCT) is designed to test ascending and descending stair activity, and measures the time in seconds to ascend and descend a flight of stairs. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Measured: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
Patient reported outcome measure: Pain at rest
Measured using Numeric Rating Scale (NRS) for pain at rest
Measured: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: Pain during movement
Measured using Numeric Rating Scale (NRS) for pain during movement
Measured: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: Oxford Hip Score (OHS)
The Oxford Hip Score (OHS) is a hip specific questionnaire, consisting of 12 items concerning pain and daily functions. In the original scoring, each question is scored on a 5-point Likert scale, ranging from 1 (no pain/easy to do) to 5 (unbearable/impossible to do). The original total score ranges from 12 (best) to 60 (worst) points. It has been developed for total hip surgery. In the revised scoring, each question is scored from 0 (worst) to 4 (best), ranging the total score from 0 (worst) to 48 (best) (20). The revised scoring will be used in this study.
Measured: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: HOOS-PS
The HOOS-PS is a short measure of physical function for hip osteoarthritis (OA), derived from the original, longer, Hip disability and Osteoarthritis Outcome Score (HOOS). The raw scoring ranges from 0 (none) to 4 (extreme) per question, for a total raw score range of 0 to 20 (lower is less difficulty). The person interval level score ranges, which can be calculated from the total raw score using a nomogram, ranges from 0 (no difficulty) to 100 (extreme difficulty).
Measured: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: EQ-5D-5L
EuroQol-5D (EQ-5D) is a general health-related quality of life questionnaire and consists of five questions regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression and one visual analog scale (VAS) to document the perceived quality of life. It is also used to assess quality adjusted life years (QALY).
Measured: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: Satisfaction
Anchor question regarding how satisfied the subject is (in general) with the results of his/her hip surgery?
Measured: 6 weeks, 3 months and 1 year postoperatively.
Cup inclination
Categorized into ≤35°, 35° - 45° and ≥45°
Measured: 6 weeks postoperatively
Complications
Postoperative complications as recorded in the electronic patient file
Measured: 30 days postoperatively and 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start8 Sep 2022
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loosening, ProsthesisStudies 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
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reinier Haga Orthopedisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M. Rutgers, MD, Principal investigator, Reinier Haga Orthopedisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508958
- Sponsor's protocol ID
- OC-2020-018
- Status last verified
- Sep 2022
- First submitted
- 12 Aug 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Recovery After Cup Revision - is the Anterior Approach Superior to Posterolateral?
- ClinicalTrials.gov ID
- NCT05508958
- Acronym / sponsor ID
- OC-2020-018
- Conditions
- Loosening, Prosthesis
- Keywords
- Isolated cup revision, Hip revision surgery, Anterior approach, Posterolateral approach, Cup revision surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Reinier Haga Orthopedisch CentrumUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 19 Aug 2022 (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.
With increasing numbers of total hip arthroplasties performed each year, the incidence of problems related to loosening and wear of total hip arthroplasties is expected to also increase. While the anterior approach for primary total hip arthroplasty has demonstrated to result in a faster short-term recovery than the traditional lateral and posterior approach, this effect has not yet been investigated in revision surgery. Accelerating functional outcome may increase patient satisfaction and reduce healthcare costs.
The primary objective is to assess whether isolated cup revision surgery through the anterior approach results in increased functional status and higher patient satisfaction than through the posterolateral approach.
This is a prospective Randomized Controlled Trial (RCT) in which 68 patients will be included (34 per group). Patients will be evaluated preoperatively and 6 weeks, 3 months and 1 year postoperatively.
The main endpoints are functional recovery as measured with the 30-sec Chair Stand Test (30s-CST), 40m Fast Paced Walking Test (40m FPWT) and the Stair Climb Test (SCT).
Secondary endpoints are Modified Borg scale outcomes after the functional tests, Numeric Rating Scale (NRS) for pain (rest/movement), Oxford Hip Score (OHS), HOOS-PS, EQ-5D-5L, satisfaction, cup inclination and complications at 30 days and 90 days postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Anterior approach | Experimental | Procedure: Anterior approachCup revision surgery through the anterior approach |
| Posterolateral approach | Active comparator | Procedure: Posterolateral approachCup revision surgery through the posterolateral approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- On waiting list or scheduled for isolated cup revision surgery through anterior or posterolateral approach
- A good command of the Dutch language
Key exclusion criteria (5 listed)
- Revision for confirmed or suspected infection
- Not suitable for both approaches under study, as judged by orthopaedic surgeon
- Unable to fully understand study information and to accurately/reliably complete the questionnaires, as judged by researcher and/or orthopaedic surgeon
- Unable to accurately follow instructions for study procedures / measurements, as judged by researcher and/or orthopaedic surgeon
- Unwilling to sign informed consent form
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 |
|---|---|---|
| Anterior approachAnterior approach | Procedure or surgery | Anterior approach |
| Posterolateral approachPosterolateral approach | Procedure or surgery | Posterolateral approach |
Primary outcome
Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks
Time frame: 6 weeks postoperatively
The 30 second Chair Stand Test (30s-CST) is designed to test the sit-to-stand activity, incorporating lower body strength and dynamic balance, and measures the maximum number of chair stand repetitions possible in a 30 second period. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks
Time frame: 6 weeks postoperatively
The 40m Fast Paced Walk Test (40m FPWT) tests walking speed over short distances and changing directions during walking. It is timed over 4 x 10 meters, for a total of 40 meters. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Change from baseline Stair Climb Test (SCT) at 6 weeks
Time frame: 6 weeks postoperatively
The Stair Climb Test (SCT) is designed to test ascending and descending stair activity, and measures the time in seconds to ascend and descend a flight of stairs. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
14 secondary outcomes
Change from baseline Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 30s-CST at 6 weeks, 3 months and 1 year
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 40m FPWT at 6 weeks, 3 months and 1 year
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during SCT at 6 weeks, 3 months and 1 year
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks, 3 months and 1 year
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks, 3 months and 1 year
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
Change from baseline Stair Climb Test (SCT) at 6 weeks, 3 months and 1 year
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
Patient reported outcome measure: Pain at rest
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: Pain during movement
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: Oxford Hip Score (OHS)
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: HOOS-PS
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: EQ-5D-5L
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: Satisfaction
Time frame: 6 weeks, 3 months and 1 year postoperatively.
Cup inclination
Time frame: 6 weeks postoperatively
Complications
Time frame: 30 days postoperatively and 90 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
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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.
M. Rutgers, MD principal investigator
Reinier Haga Orthopedisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior approach and Posterolateral approach in people with Loosening, Prosthesis, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
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 5 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: status not confirmed, as of the sponsor's last update on 13 Sep 2022. 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 Netherlands. 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?
Results are not available in the source record.
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?
Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks (time frame: 6 weeks postoperatively). 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?
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 13 Sep 2022.