Hip OsteoarthritisNCT01506024
Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results
A study testing Total hip arthroplasty direct lateral approach, Total hip arthroplasty posterior approach and Total hip arthroplasty, anterior approach in people with Hip Osteoarthritis, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of the present study is to explore the most efficient surgical approach in total hip replacement in short and long term when concerning strength, functionality and postoperative complications. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Total hip arthroplasty direct lateral approach, Total hip arthroplasty posterior approach and Total hip arthroplasty, anterior approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2011to Apr 2014
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled for THA
- Diagnosis of primary osteoarthritis as the main cause for elective THA
- American Society of Anesthesiologists (ASA) score I, II, and stable III
Who cannot join
- Musculoskeletal diseases
- Current heart/pulmonary- or malignant diseases likely to influence the physical testing performance.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study is to explore the most efficient surgical approach in total hip replacement in short and long term when concerning strength, functionality and postoperative complications.
The objective is to register muscular strength, hip joint functionality/mobilisation and complications after total hip arthroplasty (THA) performed by the direct lateral approach (DLA), the posterior approach (PA) and the anterior approach (AA). The latter is a modified Smith-Petersen approach which follows the principles of minimally invasive surgery (MIS).
The primary working hypothesis is that due to a minimal dissection and reduced trauma in the muscles, patients will tolerate early hospital discharge better after the AA than the PA and the DLA. Patients in the AA group are also thought to be more active and maintain muscular strength and hip joint functionality/mobilisation better than patients in the lateral group.
Read the detailed description
With total hip replacement surgery, the orthopaedic surgeon's aim is not only pain relief for the patient, but also restoration of hip joint biomechanics resulting in a minimal functional deficit and maximal longevity of the implant. It is not exceptional that these patients still experience mild to moderate long-term impairments postoperatively. These impairments include pain, muscle weakness of the hip abductors, contracture of the hip, gait disorders, as well as weakness of hip extensors and flexors. These problems may in turn lead to complications such as joint instability and loosening of the implant.
MIS is defined as a surgical approach performed through a short skin and muscle incision to avoid injury to muscles and tendons. Following minimally invasive approach reduced muscle trauma has been found. Moreover clinical outcome improved, as the gluteus medius muscle can be spared more successfully. However, it is debated whether or not the overall results of MIS are superior, or even as good as the traditional hip replacement surgery in terms of component placing and time to revision of the prosthesis.
- Conditions
- Hip Osteoarthritis
- Being tested
- Total hip arthroplasty direct lateral approach, Total hip arthroplasty posterior approach, Total hip arthroplasty, anterior approach
- Keywords
- Arthroplasty, Replacement, Hip, Surgical Procedures, Operative, Surgical Procedures, Minimally Invasive
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplasty direct lateral approachProcedure or surgery
Also called Total hip replacement, THA
Total hip arthroplasty posterior approachProcedure or surgery
Also called Total hip replacement, THA
Total hip arthroplasty, anterior approachProcedure or surgery
Also called Total hip replacement, THA
| Study group | Role | What they receive |
|---|---|---|
| THA Direct lateral | Active comparator | Total hip arthroplasty (THA) carried out by direct lateral approach (DLA) Receives: Procedure: Total hip arthroplasty direct lateral approach |
| THA Posterior | Experimental | Total hip arthroplasty (THA) carried out by posterior approach (DLA) Receives: Procedure: Total hip arthroplasty posterior approach |
| THA Anterior | Experimental | Total hip arthroplasty (THA) carried out by anterior approach (DLA) Receives: Procedure: Total hip arthroplasty, anterior approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Measured by 1 repetition maximum (1 RM)
Measured: 3 months postoperatively
Secondary outcomes (2)
Hip joint functionality and mobility
Measured by patient completed questionnaires and clinician reported scores
Measured: 3 months postoperatively
activity level
Measured by an activity monitor
Measured: 6 subsequent days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Lars Jacob Stovner, prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506024
- Sponsor's protocol ID
- 2011/450
- Status last verified
- Nov 2018
- First submitted
- 9 Dec 2011
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Winther SB, Husby VS, Foss OA, Wik TS, Svenningsen S, Engdal M, Haugan K, Husby OS. Muscular strength after total hip arthroplasty. A prospective comparison of 3 surgical approaches. Acta Orthop. 2016 Feb;87(1):22-8. doi: 10.3109/17453674.2015.1068032. Epub 2015 Aug 27.
PubMed 26141371Winther SB, Foss OA, Husby OS, Wik TS, Klaksvik J, Husby VS. Muscular strength and function after total hip arthroplasty performed with three different surgical approaches: one-year follow-up study. Hip Int. 2019 Jul;29(4):405-411. doi: 10.1177/1120700018810673. Epub 2018 Nov 13.
PubMed 30421633
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results
- ClinicalTrials.gov ID
- NCT01506024
- Acronym / sponsor ID
- 2011/450
- Conditions
- Hip Osteoarthritis
- Keywords
- Arthroplasty, Replacement, Hip, Surgical Procedures, Operative, Surgical Procedures, Minimally Invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2011 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Jan 2012 (estimated)
- 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 aim of the present study is to explore the most efficient surgical approach in total hip replacement in short and long term when concerning strength, functionality and postoperative complications.
The objective is to register muscular strength, hip joint functionality/mobilisation and complications after total hip arthroplasty (THA) performed by the direct lateral approach (DLA), the posterior approach (PA) and the anterior approach (AA). The latter is a modified Smith-Petersen approach which follows the principles of minimally invasive surgery (MIS).
The primary working hypothesis is that due to a minimal dissection and reduced trauma in the muscles, patients will tolerate early hospital discharge better after the AA than the PA and the DLA. Patients in the AA group are also thought to be more active and maintain muscular strength and hip joint functionality/mobilisation better than patients in the lateral group.
Detailed description
With total hip replacement surgery, the orthopaedic surgeon's aim is not only pain relief for the patient, but also restoration of hip joint biomechanics resulting in a minimal functional deficit and maximal longevity of the implant. It is not exceptional that these patients still experience mild to moderate long-term impairments postoperatively. These impairments include pain, muscle weakness of the hip abductors, contracture of the hip, gait disorders, as well as weakness of hip extensors and flexors. These problems may in turn lead to complications such as joint instability and loosening of the implant.
MIS is defined as a surgical approach performed through a short skin and muscle incision to avoid injury to muscles and tendons. Following minimally invasive approach reduced muscle trauma has been found. Moreover clinical outcome improved, as the gluteus medius muscle can be spared more successfully. However, it is debated whether or not the overall results of MIS are superior, or even as good as the traditional hip replacement surgery in terms of component placing and time to revision of the prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THA Direct lateral | Active comparator | Procedure: Total hip arthroplasty direct lateral approachTotal hip arthroplasty (THA) carried out by direct lateral approach (DLA) |
| THA Posterior | Experimental | Procedure: Total hip arthroplasty posterior approachTotal hip arthroplasty (THA) carried out by posterior approach (DLA) |
| THA Anterior | Experimental | Procedure: Total hip arthroplasty, anterior approachTotal hip arthroplasty (THA) carried out by anterior approach (DLA) |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for THA
- Diagnosis of primary osteoarthritis as the main cause for elective THA
- American Society of Anesthesiologists (ASA) score I, II, and stable III
Key exclusion criteria (2 listed)
- Musculoskeletal diseases
- Current heart/pulmonary- or malignant diseases likely to influence the physical testing performance.
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 |
|---|---|---|
| Total hip arthroplasty direct lateral approachAlso: Total hip replacement, THA | Procedure or surgery | THA Direct lateral |
| Total hip arthroplasty posterior approachAlso: Total hip replacement, THA | Procedure or surgery | THA Posterior |
| Total hip arthroplasty, anterior approachAlso: Total hip replacement, THA | Procedure or surgery | THA Anterior |
Primary outcome
Muscle strength
Time frame: 3 months postoperatively
Measured by 1 repetition maximum (1 RM)
2 secondary outcomes
Hip joint functionality and mobility
Time frame: 3 months postoperatively
activity level
Time frame: 6 subsequent days postoperatively
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 Nov 2018.
- Results publication: PubMed 26141371Winther SB, Husby VS, Foss OA, Wik TS, Svenningsen S, Engdal M, Haugan K, Husby OS. Muscular strength after total hip arthroplasty. A prospective comparison of 3 surgical approaches. Acta Orthop. 2016 Feb;87(1):22-8. doi: 10.3109/17453674.2015.1068032. Epub 2015 Aug 27.
- Results publication: PubMed 30421633Winther SB, Foss OA, Husby OS, Wik TS, Klaksvik J, Husby VS. Muscular strength and function after total hip arthroplasty performed with three different surgical approaches: one-year follow-up study. Hip Int. 2019 Jul;29(4):405-411. doi: 10.1177/1120700018810673. Epub 2018 Nov 13.
- Individual participant dataSharing planned: Undecided
Related trials for Hip Osteoarthritis
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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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.
Lars Jacob Stovner, prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hip arthroplasty direct lateral approach, Total hip arthroplasty posterior approach and Total hip arthroplasty, anterior approach in people with Hip Osteoarthritis, run by Norwegian University of Science and Technology 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 2 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 Nov 2018. 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?
Muscle strength (time frame: 3 months postoperatively). 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 NCT01506024, which also lists 2 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 Nov 2018.