Hip OsteoarthritisDROMDPNCT02047292
Dynamic ROM Via Gait Analysis and 3D Fluoroscopy in THA With Different Head Diameters
A study testing THA Corail PinnacleCoC28, THA Corail DeltaMotion36 and THA Corail DeltaMotion40 in people with Hip Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Pain and reduced function are the most common symptoms of coxarthritis. Pain relief and normal range of motion (ROM) restoration are the objectives of a Total Hip Arthroplasty (THA) procedure. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- THA Corail PinnacleCoC28, THA Corail DeltaMotion36 and THA Corail DeltaMotion40
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to 21 Dec 2017
- 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with unilateral primary or secondary hip arthrosis indicated for THA;
- Men and female, age between 35 and 55 years old;
- BMI smaller than 30;
- Patients able to understand the protocol and to sign the informed consent.
Who cannot join
- Child-bearing female;
- Patients with also controlateral hip arthritis;
- Neurological patients, because of possible alteration of neuro-muscular control of the replaced hip;
- Patients treated with joint replacement at any other lower limb articulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Range of Motion (ROM) Assessment Using Gait Analysis and Three-dimensional Fluoroscopy in Patients Treated by Total Hip Arthroplasty (THA) With Different Head Diameters
Pain and reduced function are the most common symptoms of coxarthritis. Pain relief and normal range of motion (ROM) restoration are the objectives of a Total Hip Arthroplasty (THA) procedure. It is recognized that increased head-neck ratio results in increased ROM due to the fact that prosthetic impingement between neck and acetabular liner occurs with wider arcs of motion. This head-neck ratio has been investigated extensively only in vitro (on cadavers or sawbones) or using mathematical modeling in computer simulations. These studies are limited by the lack of soft tissues and muscle activations in the models. This study will clinically assess the effect of prosthetic head diameter on patient capability of performing movements which require extreme arcs of motion of the hip joint. Therefore, the research questions are:
- What role do soft tissues play in limiting ROM?
- Can prosthetic impingement really occur in a well positioned THA?
- Can a bigger head diameter alone reduce the risk of impingement?
Read the detailed description
This will be a prospective comparative randomized double-blind Study (both patient and the clinical engineer performing the gait analysis will be blind with respect to the prosthetic head diameter implanted). Patient recruitment will last 12 months and the Study will have a follow-up period of 12 months. A total number of 45 patients will be recruited. Patients will be randomly allocated into three groups: the first group will undergo THA with a 28mm diameter head (Pinnacle Acetabular System, with a ceramic on ceramic - CoC - bearing), in the second group THA will be performed using a 36 mm diameter head (DeltaMotion), finally patients in the third group will undergo THA with a 40 mm diameter head (DeltaMotion). Patients will be operated by three surgeons of the same hospital according to the same surgical procedure and using the same direct lateral approach. All patients will receive a Corail stem and will follow the same rehabilitation program.
- Primary endpoint: Gait analysis and fluoroscopy will provide quantitative information of prosthesis in vivo performance, e.g. what is the arc (degrees) of active or passive motion when prosthetic impingement occurs?
- Secondary endpoint(s): these analyses will also allow to: 1) assess ROM of the operated hip versus contralateral non operated hip and the effect of prosthetic head diameter and any correlation to hip functional scores validated and commonly used in the Literature; 2) set reproducible criteria for in vivo fluoroscopic analysis of ROM in THA patients.
- Conditions
- Hip Osteoarthritis
- Being tested
- THA Corail PinnacleCoC28, THA Corail DeltaMotion36, THA Corail DeltaMotion40
- Keywords
- Gait analysis, 3D videofluoroscopy, Femoroacetabular impingement, Neck-cup impingement, Head-neck ratio, Hip scores, Functional assessment, Cup size, Range of motion, Unilateral Primary, Secondary
- Medical subject headings
- Osteoarthritis, Hip, Femoracetabular Impingement, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THA Corail PinnacleCoC28Device
Uncemented THA with Corail stem and Pinnacle acetabular cup with CoC 28 mm head
THA Corail DeltaMotion36Device
Uncemented THA with Corail stem and DeltaMotion acetabular cup with 36 mm head
THA Corail DeltaMotion40Device
Uncemented THA with Corail stem and DeltaMotion acetabular cup with 40 mm head
| Study group | Role | What they receive |
|---|---|---|
| THA28 | Active comparator | THA Corail PinnacleCoC28 Receives: Device: THA Corail PinnacleCoC28 |
| THA36 | Active comparator | THA Corail DeltaMotion36 Receives: Device: THA Corail DeltaMotion36 |
| THA40 | Active comparator | THA Corail DeltaMotion40 Receives: Device: THA Corail DeltaMotion40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants and Hip Joint Positions with the Occurrence of Implant Impingement
Three-dimension videofluoroscopy is used to calculate prosthesis component relative pose, and to estimate minimum distance at the areas of risk of impingement
Measured: 12 months
Number of Participants with Functional Deficits at the Hip Joint as Measured by Gait Analysis
Three-dimension kinematics and kinetics of the trunk, pelvis and lower limb joints is used during level walking and other motor tasks, as well as for the single exercises of hip joint extreme motion analyzed in videofluoroscopy, to assess thoroughly those patients with and without impingement.
Measured: 12 months
Secondary outcomes (4)
Range of Motion of the operated hip versus contralateral non-operated hip
Standard clinical range of motion at the two hips
Measured: 12 months
Correlations between prosthetic head diameter and hip functional scores
The effect of prosthetic head diameter and any correlation to hip functional scores validated and commonly used in the Literature
Measured: 12 months
Standard Clinical Hip Scores
Outcomes: Harris Hip Score, Oxford Hip Score, WOMAC, Forgotten Joint score and UCLA activity score will be assessed and recorded pre-operatively and post-operatively at one year after surgery.
Measured: pre-op, and 12 months
X-ray measurements
Radiographic assessment will also be performed at one year after surgery to assess implant position and osteointegration
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2016
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy International
- Responsible party
- Principal investigator, Alberto Leardini, DPhil, Istituto Ortopedico Rizzoli
- Investigators
- Sandro Giannini, MD, Prof, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047292
- Sponsor's protocol ID
- IORDePuyD57613
- Acronym
- DROMDP
- Status last verified
- Feb 2020
- First submitted
- 22 Jan 2014
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Range of Motion (ROM) Assessment Using Gait Analysis and Three-dimensional Fluoroscopy in Patients Treated by Total Hip Arthroplasty (THA) With Different Head Diameters
- ClinicalTrials.gov ID
- NCT02047292
- Acronym / sponsor ID
- DROMDP / IORDePuyD57613
- Conditions
- Hip Osteoarthritis
- Keywords
- Gait analysis, 3D videofluoroscopy, Femoroacetabular impingement, Neck-cup impingement, Head-neck ratio, Hip scores, Functional assessment, Cup size
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- DePuy International
- Study start
- Jan 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 28 Jan 2014 (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.
Pain and reduced function are the most common symptoms of coxarthritis. Pain relief and normal range of motion (ROM) restoration are the objectives of a Total Hip Arthroplasty (THA) procedure. It is recognized that increased head-neck ratio results in increased ROM due to the fact that prosthetic impingement between neck and acetabular liner occurs with wider arcs of motion. This head-neck ratio has been investigated extensively only in vitro (on cadavers or sawbones) or using mathematical modeling in computer simulations. These studies are limited by the lack of soft tissues and muscle activations in the models. This study will clinically assess the effect of prosthetic head diameter on patient capability of performing movements which require extreme arcs of motion of the hip joint. Therefore, the research questions are:
- What role do soft tissues play in limiting ROM?
- Can prosthetic impingement really occur in a well positioned THA?
- Can a bigger head diameter alone reduce the risk of impingement?
Detailed description
This will be a prospective comparative randomized double-blind Study (both patient and the clinical engineer performing the gait analysis will be blind with respect to the prosthetic head diameter implanted). Patient recruitment will last 12 months and the Study will have a follow-up period of 12 months. A total number of 45 patients will be recruited. Patients will be randomly allocated into three groups: the first group will undergo THA with a 28mm diameter head (Pinnacle Acetabular System, with a ceramic on ceramic - CoC - bearing), in the second group THA will be performed using a 36 mm diameter head (DeltaMotion), finally patients in the third group will undergo THA with a 40 mm diameter head (DeltaMotion). Patients will be operated by three surgeons of the same hospital according to the same surgical procedure and using the same direct lateral approach. All patients will receive a Corail stem and will follow the same rehabilitation program.
- Primary endpoint: Gait analysis and fluoroscopy will provide quantitative information of prosthesis in vivo performance, e.g. what is the arc (degrees) of active or passive motion when prosthetic impingement occurs?
- Secondary endpoint(s): these analyses will also allow to: 1) assess ROM of the operated hip versus contralateral non operated hip and the effect of prosthetic head diameter and any correlation to hip functional scores validated and commonly used in the Literature; 2) set reproducible criteria for in vivo fluoroscopic analysis of ROM in THA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THA28 | Active comparator | Device: THA Corail PinnacleCoC28THA Corail PinnacleCoC28 |
| THA36 | Active comparator | Device: THA Corail DeltaMotion36THA Corail DeltaMotion36 |
| THA40 | Active comparator | Device: THA Corail DeltaMotion40THA Corail DeltaMotion40 |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with unilateral primary or secondary hip arthrosis indicated for THA;
- Men and female, age between 35 and 55 years old;
- BMI smaller than 30;
- Patients able to understand the protocol and to sign the informed consent.
Key exclusion criteria (4 listed)
- Child-bearing female;
- Patients with also controlateral hip arthritis;
- Neurological patients, because of possible alteration of neuro-muscular control of the replaced hip;
- Patients treated with joint replacement at any other lower limb articulation
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 |
|---|---|---|
| THA Corail PinnacleCoC28Uncemented THA with Corail stem and Pinnacle acetabular cup with CoC 28 mm head | Device | THA28 |
| THA Corail DeltaMotion36Uncemented THA with Corail stem and DeltaMotion acetabular cup with 36 mm head | Device | THA36 |
| THA Corail DeltaMotion40Uncemented THA with Corail stem and DeltaMotion acetabular cup with 40 mm head | Device | THA40 |
Primary outcome
Number of Participants and Hip Joint Positions with the Occurrence of Implant Impingement
Time frame: 12 months
Three-dimension videofluoroscopy is used to calculate prosthesis component relative pose, and to estimate minimum distance at the areas of risk of impingement
Number of Participants with Functional Deficits at the Hip Joint as Measured by Gait Analysis
Time frame: 12 months
Three-dimension kinematics and kinetics of the trunk, pelvis and lower limb joints is used during level walking and other motor tasks, as well as for the single exercises of hip joint extreme motion analyzed in videofluoroscopy, to assess thoroughly those patients with and without impingement.
4 secondary outcomes
Range of Motion of the operated hip versus contralateral non-operated hip
Time frame: 12 months
Correlations between prosthetic head diameter and hip functional scores
Time frame: 12 months
Standard Clinical Hip Scores
Time frame: pre-op, and 12 months
X-ray measurements
Time frame: 12 months
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 17 Feb 2020.
- Istituto Ortopedico RizzoliLink provided by the sponsor.
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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.
Sandro Giannini, MD, Prof principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THA Corail PinnacleCoC28, THA Corail DeltaMotion36 and THA Corail DeltaMotion40 in people with Hip Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 17 Feb 2020. 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 Italy. 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?
Number of Participants and Hip Joint Positions with the Occurrence of Implant Impingement (time frame: 12 months). The study lists 2 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 17 Feb 2020.