OsteoarthritistaperlocNCT02087436

Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density

A study testing Taperloc Complete Microplasty and Taperloc Complete Standard in people with Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary purpose of this study is to measure the postoperative changes in bone mineral density, comparing the Taperloc Complete Reduced Distal Microplasty stem and the standard length Taperloc Complete Reduced Distal stem. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Osteoarthritis, Avascular Necrosis, Traumatic Arthritis
What is being tested?: Taperloc Complete Microplasty and Taperloc Complete Standard
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 2 sitesSouth Korea
Study dates: Mar 2013to Dec 2019
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients suitable for primary Total Hip Replacement
Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:
Osteoarthritis
Avascular necrosis
Legg Perthes
Rheumatoid Arthritis

Show all 12Show fewer

Diastrophic variant
Fused hip
Sequelae of Slipped capital epiphysis
Traumatic arthritis
Patients aged over 20
Patients must be able to understand instructions and be willing to return for follow-up

Who cannot join

Absolute contraindications include: infection, sepsis, and osteomyelitis.
Relative contraindications include:
uncooperative patient or patient with neurologic disorders who are incapable of following directions,
Small Femoral canal
2) Severe osteoporosis (Patients over 65 years old) 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7) vascular insufficiency, muscular atrophy, or neuromuscular disease. 8) pregnancy 9) Fracture of the pelvis 10) Subcapital fractures

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

Seoul National University Bundang Hospital
Gyeonggi-do
Chung-Ang University Hospital
Seoul

Other trials in South Korea

About this study

Read the detailed description

The Taperloc Microplasty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption. The primary aim of this study is therefore to compare the postoperative changes in bone density with the Taperloc Microplasty stem, using the standard length Taperloc stem as a control.

In addition, the Taperloc stem has historically had a neck angle of 138°. There have been criticisms that this neck angle is too high for the typical Korean population. The newer Taperloc Complete system (both Microplasty and standard length) has a neck angle of 133°. A secondary aim is Occurrence ratio of thigh pain difference between Microplasty and standard stem in Korean Population

Conditions: Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Rheumatoid Arthritis, Legg-Perthes Disease
Being tested: Taperloc Complete Microplasty, Taperloc Complete Standard
Medical subject headings: Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid, Legg-Calve-Perthes Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Taperloc Complete MicroplastyDevice
Taperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption.
Taperloc Complete StandardDevice
Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques.

Study groups in NCT02087436
Study group	Role	What they receive
Taperloc Complete Standard	Active comparator	Group one will receive a total hip replacement with Taperloc Complete Standard. Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques. Receives: Device: Taperloc Complete Standard
Taperloc Complete Microplasty	Active comparator	Group one will receive a total hip replacement with Taperloc Complete Microplasty.Taperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption. Receives: Device: Taperloc Complete Microplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

Bone Mineral Density
evaluate bone mineral density around the implant
Measured: 1 year

Secondary outcomes (11)

Radiographic Evaluation,
Radiographic measurements of stability and fixation
Measured: 2 years
VAS Score
The measurement of pain intensity
Measured: 2 years
Modified Harris Hip Score
- Over all Survivorship
- Harris Hip Score
Measured: 2 years
Radiographic Evaluation
Radiographic measurements of stability and fixation
Measured: 1 year
Radiographic Evaluation
Radiographic measurements of stability and fixation
Measured: 6 Weeks
VAS Score
The measurement of pain intensity
Measured: 1 year
VAS Score
The measurement of pain intensity
Measured: 6 Weeks
VAS Score
The measurement of pain intensity
Measured: 6 Months
Modified Harris Hip Score
- Over all Survivorship
- Harris Hip Score
Measured: 1 year
Modified Harris Hip Score
- Over all Survivorship
- Harris Hip Score
Measured: 6 Months
Bone Mineral Density
- Two X-ray beams with different energy levels are aimed at the patient's bones.
- DEXA
- evaluate the bone mineral density around the implant
Measured: Immediate post-op(2 - 4Weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Dec 2019

First posted14 Mar 2014 (estimated)
Study startMar 2013
Primary completionJul 2014
Study completionDec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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
Masking: Single blind
Who is masked: Participant
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02087436
Sponsor's protocol ID: INT.CR.GH3.13
Acronym: taperloc
Status last verified: Jul 2019
First submitted: 14 Jan 2014
Last updated: 9 Jan 2020
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis

All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density
ClinicalTrials.gov ID: NCT02087436
Acronym / sponsor ID: taperloc / INT.CR.GH3.13
Conditions: Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Rheumatoid Arthritis, Legg-Perthes Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Jul 2014 (actual)
Study completion: Dec 2019 (actual)
First posted: 14 Mar 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Taperloc Complete Standard	Active comparator	Device: Taperloc Complete StandardGroup one will receive a total hip replacement with Taperloc Complete Standard. Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques.
Taperloc Complete Microplasty	Active comparator	Device: Taperloc Complete MicroplastyGroup one will receive a total hip replacement with Taperloc Complete Microplasty.Taperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Patients suitable for primary Total Hip Replacement
Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:
Osteoarthritis
Avascular necrosis
Legg Perthes

Key exclusion criteria (5 listed)

Absolute contraindications include: infection, sepsis, and osteomyelitis.
uncooperative patient or patient with neurologic disorders who are incapable of following directions,
Small Femoral canal
2) Severe osteoporosis (Patients over 65 years old) 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7) vascular insufficiency, muscular atrophy, or neuromuscular disease. 8) pregnancy 9) Fracture of the pelvis 10) Subcapital fractures

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 MicroplastyTaperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption.	Device	Taperloc Complete Microplasty
Taperloc Complete StandardTaperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques.	Device	Taperloc Complete Standard

Primary outcome

Bone Mineral Density
Time frame: 1 year
evaluate bone mineral density around the implant

11 secondary outcomes

Radiographic Evaluation,
Time frame: 2 years
VAS Score
Time frame: 2 years
Modified Harris Hip Score
Time frame: 2 years
Radiographic Evaluation
Time frame: 1 year
Radiographic Evaluation
Time frame: 6 Weeks
VAS Score
Time frame: 1 year
VAS Score
Time frame: 6 Weeks
VAS Score
Time frame: 6 Months
Modified Harris Hip Score
Time frame: 1 year
Modified Harris Hip Score
Time frame: 6 Months
Bone Mineral Density
Time frame: Immediate post-op(2 - 4Weeks)

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 9 Jan 2020.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis

Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis

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.

Yong-Chan Ha, PHD principal investigator

Chung-Ang University Hospital

Young-Kyun Lee, PHD principal investigator

Seoul National University Bundang Hospital

2 sites 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 and Taperloc Complete Standard in people with Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 2 sites in South Korea.

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 12 inclusion and 5 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 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. 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?

Bone Mineral Density (time frame: 1 year). 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 NCT02087436.

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 9 Jan 2020.