Difficulty WalkingNCT02484781
Gait Analyses After Resurfacing Hip Arthroplasty Versus Metal on Metal Total Hip Arthroplasty, an Exploratory Study
A study testing Gait analysis on a trendmill in people with Difficulty Walking and Gait, Stumbling, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Total hip replacement surgery is a very successful operation with good long-term results. Hip resurfacing arthroplasty is offered as a treatment option for young and active patients with osteoarthritis of the hip. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficulty Walking, Gait, Stumbling
- What is being tested?
- Gait analysis on a trendmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2015to Dec 2015
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient part of randomised controlled trial (RCT) of hip resurfacing versus MoM total hip arthroplasty for symptomatic osteoarthritis of the hip
- Patient must be able to consent to the study (written informed consent)
- Patients who are functioning well post-operatively and not under routine follow up
- Patients who are able to walk without any safety rail assistance on the treadmill
Who cannot join
- Patient not originally randomised during an RCT of hip resurfacing versus MoM total hip arthroplasty
- Patients who suffer from any neurological or musculoskeletal conditions that might make a gait test dangerous.
- Patients whose cognitive function prevents them from understanding the study
- Patients who have had or are awaiting revision surgery for their hip
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gait Analyses After Resurfacing Hip Arthroplasty Versus Metal on Metal Total Hip
Total hip replacement surgery is a very successful operation with good long-term results. Hip resurfacing arthroplasty is offered as a treatment option for young and active patients with osteoarthritis of the hip. It has been proposed as a treatment option for younger patients because of claims that it preserves femoral bone stock and has better functional outcomes. The assessment of gait after hip replacement surgery may be able to determine functional differences between patients who have undergone total hip replacement / arthroplasty (THA) versus hip resurfacing.
Read the detailed description
A group of 58 patients, part of a ungoing randomized trial comparing resurfacing hip arthroplasty to metal-on-metal total hip arthroplasty, will be invited to a single gait analysis on a trendmill. All patients have reached a follow up of five years. Patient 's gait will be assessed during two walking sessions, in both sessions spatio-temporal, kinetic and kinematic parameters will be recorded.
- At first when flat walking with increasing speeds to their top walking speed.
- Secondly: when walking at a fixed speed with an increasing incline to their top walking incline.
- Conditions
- Difficulty Walking, Gait, Stumbling
- Being tested
- Gait analysis on a trendmill
- Keywords
- Gait disorder, Resurfacing Hip Arthroplasty, Total Hip Arthroplasty
- Medical subject headings
- Mobility Limitation, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysis on a trendmillOther
Also called Gait realtime analysis interactive lab: MOTEK Medical
Gait analysis on a trendmill "GRAIL" to analyse spatio-temporal kinetics and kinematics when flat walking and inclining
| Study group | Role | What they receive |
|---|---|---|
| Total Hip Arthroplasty | Active comparator | Gait analysis on a trendmill of patients with a well functioning total hip arthroplasty on a trendmill Receives: Other: Gait analysis on a trendmill |
| Resurfacing Hip Arthroplasty | Active comparator | Gait analysis on a trendmill of patients with a well functioning resurfacing hip arthroplasty on a trendmill Receives: Other: Gait analysis on a trendmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Top walking speed
Mean top walking speed in kilometers / hour assessed on a trendmill
Measured: 5 years postoperative
Walking cadence
Mean steps / minute at top walking speed assessed on a trendmill
Measured: 5 years postoperative
Step length
Mean step distance in meters at top walking speed assessed on a trendmill
Measured: 5 years postoperative
Maximum Push off force (N/kg) per cycle
Mean ground reaction forces in Newton / kilogram on a trendmill
Measured: 5 years postoperative
Maximum weight acceptance (N/kg) per cycle
Mean ground reaction forces assessed on a trendmill
Measured: 5 years postoperative
Mid-stance force (N/kg) per cycle
Mean ground reaction forces assessed on a trendmill
Measured: 5 years postoperative
Hip maximum flexion/extension per cycle
Mean hip kinematics in degrees assessed on a trendmill
Measured: 5 years postoperative
Hip maximum internal/external rotation per cycle
Mean hip kinematics in degrees assessed on a trendmill
Measured: 5 years postoperative
Secondary outcomes (3)
Postoperative hip functionality after hip arthroplasty.
Postoperative hip function according the Harris Hip Score and Western Ontario and McMaster Universities Osteoarthritis Index
Measured: 5 years postoperative
General Health according EurQol-5D
Health outcome on the EQ-5D questionairre
Measured: 5 years postoperative
Physical activity level according the UCLA-activity score
The University of California at Los Angeles (UCLA) activity score
Measured: 5 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Difficulty WalkingStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RMC Groot Klimmendaal
- Responsible party
- Principal investigator, Job van Susante, Rijnstate Hospital
- Investigators
- Job LC Susante, Dr, Principal investigator, Rijnstate Hospital, orthopedic surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484781
- Sponsor's protocol ID
- LTC 2015-0576
- Status last verified
- Jul 2016
- First submitted
- 9 Jun 2015
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Aqil A, Drabu R, Bergmann JH, Masjedi M, Manning V, Andrews B, Muirhead-Allwood SK, Cobb JP. The gait of patients with one resurfacing and one replacement hip: a single blinded controlled study. Int Orthop. 2013 May;37(5):795-801. doi: 10.1007/s00264-013-1819-3. Epub 2013 Feb 27.
PubMed 23443980
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analyses After Resurfacing Hip Arthroplasty Versus Metal on Metal Total Hip
- ClinicalTrials.gov ID
- NCT02484781
- Acronym / sponsor ID
- LTC 2015-0576
- Conditions
- Difficulty Walking, Gait, Stumbling
- Keywords
- Gait disorder, Resurfacing Hip Arthroplasty, Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- RMC Groot Klimmendaal
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Jun 2015 (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.
Total hip replacement surgery is a very successful operation with good long-term results. Hip resurfacing arthroplasty is offered as a treatment option for young and active patients with osteoarthritis of the hip. It has been proposed as a treatment option for younger patients because of claims that it preserves femoral bone stock and has better functional outcomes. The assessment of gait after hip replacement surgery may be able to determine functional differences between patients who have undergone total hip replacement / arthroplasty (THA) versus hip resurfacing.
Detailed description
A group of 58 patients, part of a ungoing randomized trial comparing resurfacing hip arthroplasty to metal-on-metal total hip arthroplasty, will be invited to a single gait analysis on a trendmill. All patients have reached a follow up of five years. Patient 's gait will be assessed during two walking sessions, in both sessions spatio-temporal, kinetic and kinematic parameters will be recorded.
- At first when flat walking with increasing speeds to their top walking speed.
- Secondly: when walking at a fixed speed with an increasing incline to their top walking incline.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Hip Arthroplasty | Active comparator | Other: Gait analysis on a trendmillGait analysis on a trendmill of patients with a well functioning total hip arthroplasty on a trendmill |
| Resurfacing Hip Arthroplasty | Active comparator | Other: Gait analysis on a trendmillGait analysis on a trendmill of patients with a well functioning resurfacing hip arthroplasty on a trendmill |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient part of randomised controlled trial (RCT) of hip resurfacing versus MoM total hip arthroplasty for symptomatic osteoarthritis of the hip
- Patient must be able to consent to the study (written informed consent)
- Patients who are functioning well post-operatively and not under routine follow up
- Patients who are able to walk without any safety rail assistance on the treadmill
Key exclusion criteria (4 listed)
- Patient not originally randomised during an RCT of hip resurfacing versus MoM total hip arthroplasty
- Patients who suffer from any neurological or musculoskeletal conditions that might make a gait test dangerous.
- Patients whose cognitive function prevents them from understanding the study
- Patients who have had or are awaiting revision surgery for their hip
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 |
|---|---|---|
| Gait analysis on a trendmillAlso: Gait realtime analysis interactive lab: MOTEK MedicalGait analysis on a trendmill "GRAIL" to analyse spatio-temporal kinetics and kinematics when flat walking and inclining | Other | Resurfacing Hip Arthroplasty, Total Hip Arthroplasty |
Primary outcome
Top walking speed
Time frame: 5 years postoperative
Mean top walking speed in kilometers / hour assessed on a trendmill
Walking cadence
Time frame: 5 years postoperative
Mean steps / minute at top walking speed assessed on a trendmill
Step length
Time frame: 5 years postoperative
Mean step distance in meters at top walking speed assessed on a trendmill
Maximum Push off force (N/kg) per cycle
Time frame: 5 years postoperative
Mean ground reaction forces in Newton / kilogram on a trendmill
Maximum weight acceptance (N/kg) per cycle
Time frame: 5 years postoperative
Mean ground reaction forces assessed on a trendmill
Mid-stance force (N/kg) per cycle
Time frame: 5 years postoperative
Mean ground reaction forces assessed on a trendmill
Hip maximum flexion/extension per cycle
Time frame: 5 years postoperative
Mean hip kinematics in degrees assessed on a trendmill
Hip maximum internal/external rotation per cycle
Time frame: 5 years postoperative
Mean hip kinematics in degrees assessed on a trendmill
3 secondary outcomes
Postoperative hip functionality after hip arthroplasty.
Time frame: 5 years postoperative
General Health according EurQol-5D
Time frame: 5 years postoperative
Physical activity level according the UCLA-activity score
Time frame: 5 years postoperative
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 15 Jul 2016.
- Background: PubMed 23443980Aqil A, Drabu R, Bergmann JH, Masjedi M, Manning V, Andrews B, Muirhead-Allwood SK, Cobb JP. The gait of patients with one resurfacing and one replacement hip: a single blinded controlled study. Int Orthop. 2013 May;37(5):795-801. doi: 10.1007/s00264-013-1819-3. Epub 2013 Feb 27.
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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.
Job LC Susante, Dr principal investigator
Rijnstate Hospital, orthopedic surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait analysis on a trendmill in people with Difficulty Walking and Gait, Stumbling, run by Rijnstate Hospital 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 4 inclusion and 4 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 15 Jul 2016. 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?
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?
Top walking speed (time frame: 5 years postoperative). The study lists 8 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 NCT02484781, which also lists 1 linked publication.
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 15 Jul 2016.