ArthroplastyPhase 4NCT04516239
Comparison of Metal on Metal Total Hip Arthroplasty and Metal on Metal Total Hip Resurfacing.
A Phase 4 study testing THA and HR in people with Arthroplasty and Replacement, run by Ciusss de L'Est de l'Île de Montréal.
Trial summary
The goal of this double-blind prospective randomized study is to compare subjective outcome measures and gait parameters between conventional THA using large diameter femoral heads and total hip resurfacing Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- THA and HR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Jul 2020
- Phase
- Phase 4
- 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
- Patient with degenerative disease of the hip in need for total hip or total hip resurfacing arthroplasty
- Patient who understands the study protocol and willing to comply with the planned clinical follow-up
- Patient can give informed consent
Who cannot join
- Age older than 65 years old or younger than 18 years old
- Charnley class B (both hip diseased) or C (polyarticular disease) patients
- Spinal or lower limb disease other than the degenerated hip that could influence gait and walking performance
- Neuromuscular disorder
- Known or suspected metal allergy
- Pregnancy
- Renal insufficiency
- Known or suspected osteopenia or osteoporosis of the hip
About this study
Official title: Prospective Double-blind Randomized Clinical Trial Comparing Gait Analysis and Clinical Function After Metal on Metal Total Hip Arthroplasty With Large Diameter Femoral Head and Metal on Metal Total Hip Resurfacing.
The goal of this double-blind prospective randomized study is to compare subjective outcome measures and gait parameters between conventional THA using large diameter femoral heads and total hip resurfacing
Read the detailed description
In the early 1960's Sir John Charnley revolutionized total hip arthroplasty (THA) with the introduction of polyethylene as a bearing surface. This innovation allowed THA to become a very successful procedure to treat degeneration of the hip joint, with excellent long term clinical outcome and patient satisfaction.
However, this technique requires sacrifice of the whole femoral head and part of the neck. This bone will not be available for future revision surgery, which seems inevitable in the younger patient. THA does not always allow precise reconstitution of normal hip biomechanics. The femoral canal is also violated, fat and cement embolism can occur and thrombogenic material is released in the bloodstream. Postoperatively the femoral stem can cause thigh pain, proximal stress shielding, and periprosthetic fracture may occur . Finally the use of a 28 millimeter non anatomic femoral head during conventional THA increases the risk of hip impingement and dislocation while limiting hip range of motion.
There is renewed interest in the concept of hip resurfacing and the use of large diameter femoral heads in total hip arthroplasty, since both these options recreate more optimal hip biomechanics. Total hip resurfacing is less invasive than conventional THA using a femoral stem and allows restoration of normal hip anatomy. Additionally, compared to conventional THA, hip resurfacing has the following advantages: preservation of the femoral head and neck, better hip stability, improved hip biomechanics (leg length, offset) and possibly better proprioception. Since the femoral canal is not violated, there is less risk of residual thigh pain, and patients probably have the sensation of a more normal feeling joint.
As for conventional THA with large diameter femoral heads, the use of a near anatomic head size (compared to the small 28mm diameter head use with conventional THA) restores normal stability, helps reduce the incidence of impingement and increases range of motion to a greater extent than hip resurfacing, and might improve proprioception as well. The investigators believe these advantages will have a positive influence on clinical function and gait pattern compared to conventional THA.
Gait analysis has demonstrated that gait pattern is modified after THA and patients do not recover normal gait. Kinematics analysis further showed that abnormal gait pattern is not only observed in the operated hip but also in other articulations, including the contra lateral limb. Walking kinetics are affected to some extent, especially the force generated by the lower limb and synchronization of muscle activity. Finally a subjective feeling of an abnormal hip function may still persists after THA.
The goal of this double-blind prospective randomized study is to compare subjective outcome measures and gait parameters between conventional THA using large diameter femoral heads and total hip resurfacing
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- THA, HR
- Keywords
- Metal-Metal, Large Diameter Head Total Hip Arthroplasty, Hip Resurfacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THADevice
Three surgeons performed the surgeries through a posterior surgical approach in both groups. The fascia lata was opened and the gluteus maximus was split in line with its muscle fibers. The short external rotators were released from the greater trochanter. A posterior capsulotomy was performed and the hip dislocated. For the THA, the standard techniques proposed by the manufacturer for insertion of the stem were followed. Neck sleeve adapters and three different prosthetic neck-shaft angles (125, 135, and 145) were available to adjust leg length and femoral offset with the large-diameter head THA system.
HRDevice
Three surgeons performed the surgeries through a posterior surgical approach in both groups. The fascia lata was opened and the gluteus maximus was split in line with its muscle fibers. The short external rotators were released from the greater trochanter. A posterior capsulotomy was performed and the hip dislocated. In the HR group, the capsulotomy was completed circumferentially, and the gluteus tendinous insertion on the femur was released in all men, but only when needed in women, to improve femur mobilization.
| Study group | Role | What they receive |
|---|---|---|
| LDH THA | Active comparator | large diameter head total hip arthroplasty Receives: Device: THA |
| HR | Active comparator | metal-on-metalhip resurfacing Receives: Device: HR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant revisions
Implant revisions rate will be compared between groups.
Measured: Preoperative to 15 years
Reasons of revisions
Reasons of revisions will be categorized and compared between groups.
Measured: Preoperative to 15 years
Adverse events
Adverse events will be categorized and compared between groups.
Measured: Preoperative to 15 years
Secondary outcomes (8)
Patient reported outcome measures (PROMs) : Womac
Womac score will be compared between groupsScore and Patient's Joint Perception.
Measured: Preoperative to 15 years
Patient reported outcome measures (PROMs) : UCLA activity
The UCLA activity score will be compared between groups.
Measured: Preoperative to 15 years
Patient reported outcome measures (PROMs) : Forgotten Joint
Forgotten Joint score will be compared between groups.
Measured: Preoperative to 15 years
Whole blood chromium metal ions levels
Whole blood chromium metal ion measurements will be compared between groups for participants without other bodily metallic implants or revised implants.
Measured: Preoperative to 15 years
Whole blood cobalt metal ions levels
Whole blood cobalt metal ion measurements will be compared between groups for participants without other bodily metallic implants or revised implants.
Measured: Preoperative to 15 years
Radiological evaluation of femoral stem loosening
Signs of definite femoral stem loosening included continuous lucent lines > 2 mm, stem fracture, subsidence > 5 mm, or a change in component angulation >5° will be compared between groups.
Measured: Preoperative to 15 years
Radiological evaluation of acetabular loosening
Signs of definite acetabular loosening presented as continuous radiolucency > 2 mm, component migration > 3 mm or angulation change >5° will be compared between groups.
Measured: Preoperative to 15 years
Radiological evaluation of heterotopic ossification
Signs of heterotopic ossification grade, estimated according to the Brooker classification, will be compared between groups.
Measured: Preoperative to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study startSep 2005
- Primary completionSep 2007
- Study completionJul 2020
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 ArthroplastyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective randomized clinical trial with two parallel treatment groups. At the preoperative teaching session, the study objectives and the risks and benefits of surgery will be explained to the patient by the research assistant or the surgeon in order to obtain consent. A randomization table will be generated by the SPSS 10 software and sealed numerated envelopes will be assigned to each patient entering the study. A research assistant will coordinate the study and data collection.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascal-André Vendittoli, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516239
- Sponsor's protocol ID
- 04132
- Status last verified
- Mar 2021
- First submitted
- 12 Aug 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kostretzis L, Lavigne M, Kiss MO, Shahin M, Barry J, Vendittoli PA. Despite higher revision rate, MoM large-head THA offers better clinical scores than HR: 14-year results from a randomized controlled trial involving 48 patients. BMC Musculoskelet Disord. 2021 Apr 30;22(1):400. doi: 10.1186/s12891-021-04286-6.
PubMed 33941155
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Double-blind Randomized Clinical Trial Comparing Gait Analysis and Clinical Function After Metal on Metal Total Hip Arthroplasty With Large Diameter Femoral Head and Metal on Metal Total Hip Resurfacing.
- ClinicalTrials.gov ID
- NCT04516239
- Acronym / sponsor ID
- 04132
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Metal-Metal, Large Diameter Head Total Hip Arthroplasty, Hip Resurfacing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- Sep 2005 (actual)
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 18 Aug 2020 (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.
The goal of this double-blind prospective randomized study is to compare subjective outcome measures and gait parameters between conventional THA using large diameter femoral heads and total hip resurfacing
Detailed description
In the early 1960's Sir John Charnley revolutionized total hip arthroplasty (THA) with the introduction of polyethylene as a bearing surface. This innovation allowed THA to become a very successful procedure to treat degeneration of the hip joint, with excellent long term clinical outcome and patient satisfaction.
However, this technique requires sacrifice of the whole femoral head and part of the neck. This bone will not be available for future revision surgery, which seems inevitable in the younger patient. THA does not always allow precise reconstitution of normal hip biomechanics. The femoral canal is also violated, fat and cement embolism can occur and thrombogenic material is released in the bloodstream. Postoperatively the femoral stem can cause thigh pain, proximal stress shielding, and periprosthetic fracture may occur . Finally the use of a 28 millimeter non anatomic femoral head during conventional THA increases the risk of hip impingement and dislocation while limiting hip range of motion.
There is renewed interest in the concept of hip resurfacing and the use of large diameter femoral heads in total hip arthroplasty, since both these options recreate more optimal hip biomechanics. Total hip resurfacing is less invasive than conventional THA using a femoral stem and allows restoration of normal hip anatomy. Additionally, compared to conventional THA, hip resurfacing has the following advantages: preservation of the femoral head and neck, better hip stability, improved hip biomechanics (leg length, offset) and possibly better proprioception. Since the femoral canal is not violated, there is less risk of residual thigh pain, and patients probably have the sensation of a more normal feeling joint.
As for conventional THA with large diameter femoral heads, the use of a near anatomic head size (compared to the small 28mm diameter head use with conventional THA) restores normal stability, helps reduce the incidence of impingement and increases range of motion to a greater extent than hip resurfacing, and might improve proprioception as well. The investigators believe these advantages will have a positive influence on clinical function and gait pattern compared to conventional THA.
Gait analysis has demonstrated that gait pattern is modified after THA and patients do not recover normal gait. Kinematics analysis further showed that abnormal gait pattern is not only observed in the operated hip but also in other articulations, including the contra lateral limb. Walking kinetics are affected to some extent, especially the force generated by the lower limb and synchronization of muscle activity. Finally a subjective feeling of an abnormal hip function may still persists after THA.
The goal of this double-blind prospective randomized study is to compare subjective outcome measures and gait parameters between conventional THA using large diameter femoral heads and total hip resurfacing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a prospective randomized clinical trial with two parallel treatment groups. At the preoperative teaching session, the study objectives and the risks and benefits of surgery will be explained to the patient by the research assistant or the surgeon in order to obtain consent. A randomization table will be generated by the SPSS 10 software and sealed numerated envelopes will be assigned to each patient entering the study. A research assistant will coordinate the study and data collection.
| Arm | Type | Receives |
|---|---|---|
| LDH THA | Active comparator | Device: THAlarge diameter head total hip arthroplasty |
| HR | Active comparator | Device: HRmetal-on-metalhip resurfacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with degenerative disease of the hip in need for total hip or total hip resurfacing arthroplasty
- Patient who understands the study protocol and willing to comply with the planned clinical follow-up
- Patient can give informed consent
Key exclusion criteria (8 listed)
- Age older than 65 years old or younger than 18 years old
- Charnley class B (both hip diseased) or C (polyarticular disease) patients
- Spinal or lower limb disease other than the degenerated hip that could influence gait and walking performance
- Neuromuscular disorder
- Known or suspected metal allergy
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 |
|---|---|---|
| THAThree surgeons performed the surgeries through a posterior surgical approach in both groups. The fascia lata was opened and the gluteus maximus was split in line with its muscle fibers. The short external rotators were released from the greater trochanter. A posterior capsulotomy was performed and the hip dislocated. For the THA, the standard techniques proposed by the manufacturer for insertion of the stem were followed. Neck sleeve adapters and three different prosthetic neck-shaft angles (125, 135, and 145) were available to adjust leg length and femoral offset with the large-diameter head THA system. | Device | LDH THA |
| HRThree surgeons performed the surgeries through a posterior surgical approach in both groups. The fascia lata was opened and the gluteus maximus was split in line with its muscle fibers. The short external rotators were released from the greater trochanter. A posterior capsulotomy was performed and the hip dislocated. In the HR group, the capsulotomy was completed circumferentially, and the gluteus tendinous insertion on the femur was released in all men, but only when needed in women, to improve femur mobilization. | Device | HR |
Primary outcome
Implant revisions
Time frame: Preoperative to 15 years
Implant revisions rate will be compared between groups.
Reasons of revisions
Time frame: Preoperative to 15 years
Reasons of revisions will be categorized and compared between groups.
Adverse events
Time frame: Preoperative to 15 years
Adverse events will be categorized and compared between groups.
8 secondary outcomes
Patient reported outcome measures (PROMs) : Womac
Time frame: Preoperative to 15 years
Patient reported outcome measures (PROMs) : UCLA activity
Time frame: Preoperative to 15 years
Patient reported outcome measures (PROMs) : Forgotten Joint
Time frame: Preoperative to 15 years
Whole blood chromium metal ions levels
Time frame: Preoperative to 15 years
Whole blood cobalt metal ions levels
Time frame: Preoperative to 15 years
Radiological evaluation of femoral stem loosening
Time frame: Preoperative to 15 years
Radiological evaluation of acetabular loosening
Time frame: Preoperative to 15 years
Radiological evaluation of heterotopic ossification
Time frame: Preoperative to 15 years
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 Mar 2021.
- Derived from this study: PubMed 33941155Kostretzis L, Lavigne M, Kiss MO, Shahin M, Barry J, Vendittoli PA. Despite higher revision rate, MoM large-head THA offers better clinical scores than HR: 14-year results from a randomized controlled trial involving 48 patients. BMC Musculoskelet Disord. 2021 Apr 30;22(1):400. doi: 10.1186/s12891-021-04286-6.
- The John Charnley Award: The functional outcome of hip resurfacing and large-head THA is the same: a randomized, double-blind studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing THA and HR in people with Arthroplasty and Replacement, run by Ciusss de L'Est de l'Île de Montréal.
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 8 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 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Implant revisions (time frame: Preoperative to 15 years). 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?
On the ClinicalTrials.gov record for NCT04516239, 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 16 Mar 2021.