Hip OsteoarthritisNCT03409666
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
A study testing Taperloc Complete Microplasty stem and Taperloc Complete Reduced Distal stem in people with Hip Osteoarthritis and Noninflammatory Degenerative Joint Disease, run by Zimmer Biomet at 1 site in Netherlands.
Trial summary
This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis
- What is being tested?
- Taperloc Complete Microplasty stem and Taperloc Complete Reduced Distal stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 May 2017to 6 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
- Correction of functional deformity.
- Male or female
- -≥ 18 and ≤ 70 years of age
- Subjects willing to return for follow-up evaluations.
- Subjects able to read and understand Dutch language.
Who cannot join
- active Infection (or within 6 weeks after infection)
- Sepsis
- Osteomyelitis
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- diagnosed Osteoporosis or Osteomalacia
- Metabolic disorders which may impair bone formation
Show all 9Show fewer
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy or neuromuscular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.
Read the detailed description
A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner.
All potential study subjects will be required to participate in the Informed Consent process.
- Conditions
- Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Correction of Functional Deformity, Rheumatoid Arthritis
- Being tested
- Taperloc Complete Microplasty stem, Taperloc Complete Reduced Distal stem
- Keywords
- Total Hip Arthroplasty, Medical Device, Performance, Safety, Hip prosthesis, Roentgen Stereophotogrammetric Analysis
- Medical subject headings
- Osteoarthritis, Hip, Osteonecrosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taperloc Complete Microplasty stemDevice
Also called Total hip arthroplasty
Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
Taperloc Complete Reduced Distal stemDevice
Also called Total hip arthroplasty
Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
| Study group | Role | What they receive |
|---|---|---|
| Taperloc Complete Microplasty stem | Experimental | Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem. Receives: Device: Taperloc Complete Microplasty stem |
| Taperloc Complete Reduced Distal stem | Active comparator | Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem. Receives: Device: Taperloc Complete Reduced Distal stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)
Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP)
Measured: 2 years postoperatively
Secondary outcomes (8)
Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty
Assessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation.
Measured: 2 years postoperatively
Early Survival Assessed by Counting the Number of Implant Revisions
Assessed by counting the number of implant revisions
Measured: Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)
Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis.
The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)
Measured: pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation
Assess radiographs for signs of stress shielding, radiolucency and stem alignment.
Measured: 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)
The outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms.
Measured: 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome EQ5D
Each question in the EQ5D assessment can be answered in three ways, indicating no, moderate or extreme problems. Index scores are created with a weight for each dimension, ranging from 0 (health state equivalent to death) to 1 (perfect health). The EQ5D also includes a question about health status, ranging from 0 (worst health) to 100 (best health).
Measured: 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)
The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score.
Measured: pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)
The Forgotten Joint Score (FJS) is a questionnaire, which focuses on the awareness of having a joint prosthesis.
The rationale of this questionnaire is that the ultimate goal in joint arthroplasty resulting in the greatest possible patient satisfaction is the ability to forget the artificial joint. The outcome is scored on a 0 to 100 scale, with a total score of 0 indicating the highest level of awareness of having a joint prosthesis.
Measured: 6 weeks, 1 year and 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start12 May 2017
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 Zimmer BiometThe 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
- Model description
- 1:1 assignment of treatment
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paola Vivoda, BSc, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409666
- Sponsor's protocol ID
- ORTHO.CR.GH60
- Status last verified
- Jun 2022
- First submitted
- 8 Jan 2018
- Last updated
- 14 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Koster L, Kaptein BL, Goorden E, Bell CAMP, Nelissen RGHH. Similar 2 year migration patterns for a shortened and a distally reduced stem design in uncemented total hip arthroplasty: a randomized controlled trial using radiostereometric analysis. Acta Orthop. 2026 Aug 31;97:568-575. doi: 10.2340/17453674.2026.46551.
PubMed 42670834
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
- ClinicalTrials.gov ID
- NCT03409666
- Acronym / sponsor ID
- ORTHO.CR.GH60
- Conditions
- Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Correction of Functional Deformity, Rheumatoid Arthritis
- Keywords
- Total Hip Arthroplasty, Medical Device, Performance, Safety, Hip prosthesis, Roentgen Stereophotogrammetric Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 12 May 2017 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Posted 14 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.
Detailed description
A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner.
All potential study subjects will be required to participate in the Informed Consent process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 assignment of treatment
| Arm | Type | Receives |
|---|---|---|
| Taperloc Complete Microplasty stem | Experimental | Device: Taperloc Complete Microplasty stemSubjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem. |
| Taperloc Complete Reduced Distal stem | Active comparator | Device: Taperloc Complete Reduced Distal stemSubjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
- Correction of functional deformity.
- Male or female
- -≥ 18 and ≤ 70 years of age
- Subjects willing to return for follow-up evaluations.
Key exclusion criteria (9 listed)
- active Infection (or within 6 weeks after infection)
- Sepsis
- Osteomyelitis
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- diagnosed Osteoporosis or Osteomalacia
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 |
|---|---|---|
| Taperloc Complete Microplasty stemAlso: Total hip arthroplastyTotal hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner | Device | Taperloc Complete Microplasty stem |
| Taperloc Complete Reduced Distal stemAlso: Total hip arthroplastyTotal hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner | Device | Taperloc Complete Reduced Distal stem |
Primary outcome
Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)
Time frame: 2 years postoperatively
Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP)
8 secondary outcomes
Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty
Time frame: 2 years postoperatively
Early Survival Assessed by Counting the Number of Implant Revisions
Time frame: Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)
Time frame: pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation
Time frame: 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)
Time frame: 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome EQ5D
Time frame: 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)
Time frame: pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)
Time frame: 6 weeks, 1 year and 2 years postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42670834Koster L, Kaptein BL, Goorden E, Bell CAMP, Nelissen RGHH. Similar 2 year migration patterns for a shortened and a distally reduced stem design in uncemented total hip arthroplasty: a randomized controlled trial using radiostereometric analysis. Acta Orthop. 2026 Aug 31;97:568-575. doi: 10.2340/17453674.2026.46551.
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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.
Paola Vivoda, BSc study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taperloc Complete Microplasty stem and Taperloc Complete Reduced Distal stem in people with Hip Osteoarthritis and Noninflammatory Degenerative Joint Disease, run by Zimmer Biomet 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 6 inclusion and 9 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 14 Jul 2022. 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?
Yes. Results are posted in the registry (first posted 14 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA) (time frame: 2 years 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 NCT03409666, 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 14 Jul 2022.