OsteoarthritisPhase 2RTHA and THANCT01229293
Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement
A Phase 2 study testing Articular Surface Replacement (ASR) and Standard Total Hip Arthroplasty (THA) in people with Osteoarthritis, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
This study is conducted at Odense University Hospital(OUH) in collaboration with Institute of Clinical Biomechanics and Sport Science, University of Southern Denmark and Clinical Institute, University of Southern Denmark Aim: To evaluate the effect of implant design on postoperative total leg muscle function recovery… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Articular Surface Replacement (ASR) and Standard Total Hip Arthroplasty (THA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2007to Nov 2011
- Phase
- Phase 2
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary arthrosis
Who cannot join
- Osteoporosis, (T-score < 2.5 SD) of proximal femur
- BMI > 35
- Severe acetabulum dysplasia (AP centre edge < 15-20°)
- Femur anteversion > 25°
- Severe caput deformity
- Leg length discrepancy > 1 cm
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- Off-set problems
- Earlier fracture of the ipsilateral proximal femur
- Rheumatoid arthritis
- Neuromuscular or vascular disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Orthopaedic Research Unit, Dept. of Orthopaedic Surgery and Traumatology, Odense University Hospital, Inst. of Clinical Research - University of Southern Denmark
Odense, 5000
About this study
Official title: The Effect of Implant Design on Postoperative Mechanical Muscle Function Recovery and Gait in Hip Replacement Patients: A Randomized Clinical Trail
This study is conducted at Odense University Hospital(OUH) in collaboration with Institute of Clinical Biomechanics and Sport Science, University of Southern Denmark and Clinical Institute, University of Southern Denmark
Aim: To evaluate the effect of implant design on postoperative total leg muscle function recovery and gait in hip replacement patients.
Design: A prospective randomized controlled clinical trial where patients are randomized into (A) total hip arthroplasty surgery (THA) or (B) resurfacing total hip replacement surgery (RTHA). Pre-surgery assessment and follow-up will be conducted at 8, 26 and 52 wks post-surgery.
Read the detailed description
The project consist of three substudies:
- Determination of test-retest reliability and agreement of specific mechanical muscle function variables for the patients of interest.
- Evaluate the effect of implant design on postoperative mechanical muscle recovery
- Evaluate the effect of implant design on postoperative gait
- Conditions
- Osteoarthritis
- Being tested
- Articular Surface Replacement (ASR), Standard Total Hip Arthroplasty (THA)
- Keywords
- Mechanical muscle function, Muscle strength, Hip replacement, Osteoarthritis, Hip arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articular Surface Replacement (ASR)Procedure or surgery
Articular surface replacement, DePuy, posterolateral approach used
Standard Total Hip Arthroplasty (THA)Procedure or surgery
Device: Biomet 28mm
| Study group | Role | What they receive |
|---|---|---|
| Resurfacing Total Hip Arthroplasty | Experimental | A hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint. Articular surface replacement ASR, DePuy posterolateral approach used (RTHA) Receives: Procedure: Articular Surface Replacement (ASR) |
| Standard Total Hip Arthroplasty (THA) | Active comparator | A standard 28 mm head uncemented THA Receives: Procedure: Standard Total Hip Arthroplasty (THA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal muscle strength (Peak torque, Nm)
Maximal muscle strength (peak torque, Nm) during maximal voluntary unilateral knee extension-flexion (seated), hip extension-flexion, and hip adduction-abduction (standing), respectively. Both the affected (AF) and non-affected (NA) leg
Measured: 52 wks post-surgery (primary endpoint)
Secondary outcomes (3)
Rapid force capacity (Rate of torque development, Nm/sec)
Determined as the mean tangential slope of the torque-time curve in time intervals 0-100ms (RTD100ms), 0-200ms (RTD200ms) and 0-peak (RTD peak) relative to onset of contraction (t = 0ms)
Measured: 52 wks post-surgery (primary endpoint)
Gait parameters
Selfselected, matched and maximal speed, limb index, Gait deviation index, Movement profile analysis togeter with tempo- spatial parameters
Measured: 26 wks post-surgery (primary endpoint)
Postural Control
Sway analysis (postural control) during two-leg standing, tandem, one-leg standing and during transistion from sit-to-stand.
Measured: 52 wks post-surgery (primary endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startFeb 2007
- Primary completionMar 2010
- Study completionNov 2011
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 OsteoarthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of the Interior and Health, Denmark, The Danish Rheumatism Association, Odense University Hospital
- Responsible party
- Principal investigator, Carsten Jensen, University of Southern Denmark
- Investigators
- Søren Overgaard, Prof., MD., PhD, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229293
- Sponsor's protocol ID
- VF20050133-2
- Acronym
- RTHA and THA
- Status last verified
- Sep 2012
- First submitted
- 25 Oct 2010
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jensen C, Rosenlund S, Nielsen DB, Overgaard S, Holsgaard-Larsen A. The use of the Gait Deviation Index for the evaluation of participants following total hip arthroplasty: An explorative randomized trial. Gait Posture. 2015 Jun;42(1):36-41. doi: 10.1016/j.gaitpost.2015.02.009. Epub 2015 Apr 28.
PubMed 25957650Jensen C, Aagaard P, Overgaard S. Recovery in mechanical muscle strength following resurfacing vs standard total hip arthroplasty - a randomised clinical trial. Osteoarthritis Cartilage. 2011 Sep;19(9):1108-16. doi: 10.1016/j.joca.2011.06.011. Epub 2011 Jun 28.
PubMed 21749928
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Implant Design on Postoperative Mechanical Muscle Function Recovery and Gait in Hip Replacement Patients: A Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT01229293
- Acronym / sponsor ID
- RTHA and THA / VF20050133-2
- Conditions
- Osteoarthritis
- Keywords
- Mechanical muscle function, Muscle strength, Hip replacement, Osteoarthritis, Hip arthroplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Ministry of the Interior and Health, Denmark, The Danish Rheumatism Association, Odense University Hospital
- Study start
- Feb 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 27 Oct 2010 (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.
This study is conducted at Odense University Hospital(OUH) in collaboration with Institute of Clinical Biomechanics and Sport Science, University of Southern Denmark and Clinical Institute, University of Southern Denmark
Aim: To evaluate the effect of implant design on postoperative total leg muscle function recovery and gait in hip replacement patients.
Design: A prospective randomized controlled clinical trial where patients are randomized into (A) total hip arthroplasty surgery (THA) or (B) resurfacing total hip replacement surgery (RTHA). Pre-surgery assessment and follow-up will be conducted at 8, 26 and 52 wks post-surgery.
Detailed description
The project consist of three substudies:
- Determination of test-retest reliability and agreement of specific mechanical muscle function variables for the patients of interest.
- Evaluate the effect of implant design on postoperative mechanical muscle recovery
- Evaluate the effect of implant design on postoperative gait
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resurfacing Total Hip Arthroplasty | Experimental | Procedure: Articular Surface Replacement (ASR)A hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint. Articular surface replacement ASR, DePuy posterolateral approach used (RTHA) |
| Standard Total Hip Arthroplasty (THA) | Active comparator | Procedure: Standard Total Hip Arthroplasty (THA)A standard 28 mm head uncemented THA |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary arthrosis
Key exclusion criteria (10 listed)
- Osteoporosis, (T-score < 2.5 SD) of proximal femur
- BMI > 35
- Severe acetabulum dysplasia (AP centre edge < 15-20°)
- Femur anteversion > 25°
- Severe caput deformity
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 |
|---|---|---|
| Articular Surface Replacement (ASR)Articular surface replacement, DePuy, posterolateral approach used | Procedure or surgery | Resurfacing Total Hip Arthroplasty |
| Standard Total Hip Arthroplasty (THA)Device: Biomet 28mm | Procedure or surgery | Standard Total Hip Arthroplasty (THA) |
Primary outcome
Maximal muscle strength (Peak torque, Nm)
Time frame: 52 wks post-surgery (primary endpoint)
Maximal muscle strength (peak torque, Nm) during maximal voluntary unilateral knee extension-flexion (seated), hip extension-flexion, and hip adduction-abduction (standing), respectively. Both the affected (AF) and non-affected (NA) leg
3 secondary outcomes
Rapid force capacity (Rate of torque development, Nm/sec)
Time frame: 52 wks post-surgery (primary endpoint)
Gait parameters
Time frame: 26 wks post-surgery (primary endpoint)
Postural Control
Time frame: 52 wks post-surgery (primary endpoint)
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 25 Sep 2012.
- Derived from this study: PubMed 25957650Jensen C, Rosenlund S, Nielsen DB, Overgaard S, Holsgaard-Larsen A. The use of the Gait Deviation Index for the evaluation of participants following total hip arthroplasty: An explorative randomized trial. Gait Posture. 2015 Jun;42(1):36-41. doi: 10.1016/j.gaitpost.2015.02.009. Epub 2015 Apr 28.
- Derived from this study: PubMed 21749928Jensen C, Aagaard P, Overgaard S. Recovery in mechanical muscle strength following resurfacing vs standard total hip arthroplasty - a randomised clinical trial. Osteoarthritis Cartilage. 2011 Sep;19(9):1108-16. doi: 10.1016/j.joca.2011.06.011. Epub 2011 Jun 28.
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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.
Søren Overgaard, Prof., MD., PhD study chair
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Articular Surface Replacement (ASR) and Standard Total Hip Arthroplasty (THA) in people with Osteoarthritis, run by University of Southern Denmark at 1 site in Denmark.
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 1 inclusion and 10 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 25 Sep 2012. 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 Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maximal muscle strength (Peak torque, Nm) (time frame: 52 wks post-surgery (primary endpoint)). 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 NCT01229293, 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 25 Sep 2012.