POLARSTEM Cementless Hip Stem

An observational study of Osteoarthritis, run by Smith & Nephew, Inc. at 3 sites in 2 countries.

Completed

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

Trial summary

Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Osteoarthritis
What is being tested?: Total Hip Arthroplasty
Type of treatment: Medical device
How many people: 218 participants
Where: 3 sitesin 2 countries
Study dates: Mar 2009to Nov 2020
Phase: Observational
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients enrolled in this multicenter clinical observation will have at least one of the indications listed below and meet all of the inclusion criteria. Patients meeting any of the exclusion criteria are not eligible for this study. Indications * Primary or secondary coxarthrosis * Rheumatoid arthritis * Developmental dysplasia of the hip (Crowe type I and II) * Fracture or avascular necrosis of the femoral head

Who may be able to join

Patient has no general medical contraindication to surgery
Informed consent to participate in the MCO signed by the patient
Routine radiographic assessment is possible
Patient is likely to comply with study follow-up requirements
Primary total hip replacement (THR) to the affected side, unilateral or bilateral

Who cannot join

Previously failed endoprosthesis and /or THR components in relevant hip
History of infection in the affected joint; systemic infections
Grossly insufficient femoral or acetabular bone stock in the involved hip
Charcot joint disease or other severe neurosensory deficit
Severe spinal disorders
Age of patient at date of surgery > 75 years
High comorbidity
Cemented acetabular cup

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

Germany2 sites

St. Elisabeth Hospital, Orthopedics and Rheumatology
Bochum, 44787
University Marburg, Orthopedics and Rheumatology
Marburg

Other trials in Germany

Switzerland1 site

Kantonsspital Aarau, Orthopedics
Aarau, 5001

Other trials in Switzerland

About this study

Official title: Multicenter Clinical Observation Using the Cementless Version of the POLARSTEM

Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship.

Read the detailed description

The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the POLARSTEM™.

Efficacy evaluations:

Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, Hip disability and osteoarthritis outcome score (HOOS) [7, 8], an extension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration

Safety evaluations:

Intra- and perioperative device-related adverse events (AE) and complications up to discharge
Postoperative AE up to 10 years

Conditions: Osteoarthritis
Being tested: Total Hip Arthroplasty
Medical subject headings: Osteoarthritis

What participants receive

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

Total Hip ArthroplastyDevice
Total Hip Arthroplasty using Cementless version of the POLARSTEM

What is being measured

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

Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM
Overall survivorship of the Cementless Version of the POLARSTEM pre-operatively, 3 months, 12 months, 12 months, 36 months, 60 months, and 120 months by Kaplan-Meier estimate with overall hip survivorship defined as the time between date of treatment and date of revision for any reason.
Measured: Pre-operatively, 3 months, 12 months, 36 months, 60 months, and 120 months

Secondary outcomes (10)

Harris Hip Score (HHS)
The HHS measured function, range of motion (ROM), and pain sub-scores that are combined to indicate total dysfunction on a numerical scale from 0 to 100, with a higher score indicating less dysfunction (i.e., a better outcome). Reported scores for the HHS utilized the following grading:
- <70 = poor
- 70 to 80 = fair
- 80 to 90 = good
- 90 to 100 = excellent
Measured: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Pain Subscale
WOMAC Pain subscale is a subset of the Hip Disability and Osteoarthritis Outcome Score (HOOS) with a range of 0 to 20. Higher WOMAC scores indicate worse pain (i.e., worse outcome) and lower scores indicate less pain (i.e., a better outcome).
Measured: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Stiffness Subscale
WOMAC Stiffness subscale is a subset of the Hip Disability and Osteoarthritis Outcome Score (HOOS) with a range from 0 to 8 with a higher score indicating a worse outcome and a low score indicating a better outcome.
Measured: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Physical Function Subscale
WOMAC Physical Function subscale is a subset of the Hip Disability and Osteoarthritis Outcome Score (HOOS) with a range from 0 to 68 with a higher score indicating a worse outcome and a low score indicating a better outcome.
Measured: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Total Score
WOMAC total score combines Stiffness, Pain, and Physical Function subscales of the Hip Disability and Osteoarthritis Outcome Score (HOOS) into a range from 0 to 96 with a higher score indicating a worse outcome and a lower score indicating a better outcome.
Measured: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months
Radiological: Radiolucent Lines
Number of hips identified with radiographic findings of radiolucent lines present (Yes/No) in femoral zones 1 to 14. Radiolucent lines indicated seams of 0 millimeters to 2 millimeters or greater.
Measured: 3 months, 12 months, 36 months, 60 months, 120 months
Radiological: Osteolysis
Number of hips identified with radiographic findings of osteolysis present (Yes/No) in femoral zones 1 to 14.
Measured: 3 months, 12 months, 36 months, 60 months, 120 months
Radiological: Atrophy
Number of hips identified with radiographic findings for atrophy in femoral zones 1 to 14 indicated as:
- None
- Mild
- Moderate
- Severe
- Missing
Measured: 3 months, 12 months, 36 months, 60 months, 120 months
Radiological: Hypertrophy
Number of hips identified with radiographic findings for hypertrophy in femoral zones 1 to 14 indicated as:
- None
- Mild
- Moderate
- Severe
- Missing
Measured: 3 months, 12 months, 36 months, 60 months, 120 months
Radiological: Loosening of the Implant or Migration
Number of hips identified with radiographic findings associated with loosening of the implant or migration were indicated as:
- Integration not assessable
- Indifferent, bone unchanged
- Osteointegration, integration
- Bone loss
- Signs of loosening
- Revision indicated
Measured: 3 months, 12 months, 36 months, 60 months, 120 months

Timeline

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

Mar 2009Nov 2020

First posted6 Jan 2016 (estimated)
Study startMar 2009
Primary completionNov 2020
Study completionNov 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 OsteoarthritisStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 218 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02648152
Sponsor's protocol ID: D10070-1
Acronym: POLARSTEM
Status last verified: Dec 2021
First submitted: 5 Jan 2016
Last updated: 21 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Cypres A, Fiquet A, Girardin P, Fitch D, Bauchu P, Bonnard O, Noyer D, Roy C. Long-term outcomes of a dual-mobility cup and cementless triple-taper femoral stem combination in total hip replacement: a multicenter retrospective analysis. J Orthop Surg Res. 2019 Nov 21;14(1):376. doi: 10.1186/s13018-019-1436-y.
PubMed 31752951

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

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Clinical Observation Using the Cementless Version of the POLARSTEM
ClinicalTrials.gov ID: NCT02648152
Acronym / sponsor ID: POLARSTEM / D10070-1
Conditions: Osteoarthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 218 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2009 (actual)
Primary completion: Nov 2020 (actual)
Study completion: Nov 2020 (actual)
First posted: 6 Jan 2016 (estimated)
Results: Posted 21 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship.

Detailed description

The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the POLARSTEM™.

Efficacy evaluations:

Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, Hip disability and osteoarthritis outcome score (HOOS) [7, 8], an extension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration

Safety evaluations:

Intra- and perioperative device-related adverse events (AE) and complications up to discharge
Postoperative AE up to 10 years

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients enrolled in this multicenter clinical observation will have at least one of the indications listed below and meet all of the inclusion criteria. Patients meeting any of the exclusion criteria are not eligible for this study. Indications * Primary or secondary coxarthrosis * Rheumatoid arthritis * Developmental dysplasia of the hip (Crowe type I and II) * Fracture or avascular necrosis of the femoral head

Key inclusion criteria (5 listed)

Patient has no general medical contraindication to surgery
Informed consent to participate in the MCO signed by the patient
Routine radiographic assessment is possible
Patient is likely to comply with study follow-up requirements
Primary total hip replacement (THR) to the affected side, unilateral or bilateral

Key exclusion criteria (8 listed)

Previously failed endoprosthesis and /or THR components in relevant hip
History of infection in the affected joint; systemic infections
Grossly insufficient femoral or acetabular bone stock in the involved hip
Charcot joint disease or other severe neurosensory deficit
Severe spinal disorders

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
Total Hip ArthroplastyTotal Hip Arthroplasty using Cementless version of the POLARSTEM	Device	–

Primary outcome

Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM
Time frame: Pre-operatively, 3 months, 12 months, 36 months, 60 months, and 120 months
Overall survivorship of the Cementless Version of the POLARSTEM pre-operatively, 3 months, 12 months, 12 months, 36 months, 60 months, and 120 months by Kaplan-Meier estimate with overall hip survivorship defined as the time between date of treatment and date of revision for any reason.

10 secondary outcomes

Harris Hip Score (HHS)
Time frame: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Pain Subscale
Time frame: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Stiffness Subscale
Time frame: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Physical Function Subscale
Time frame: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Total Score
Time frame: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months
Radiological: Radiolucent Lines
Time frame: 3 months, 12 months, 36 months, 60 months, 120 months
Radiological: Osteolysis
Time frame: 3 months, 12 months, 36 months, 60 months, 120 months
Radiological: Atrophy
Time frame: 3 months, 12 months, 36 months, 60 months, 120 months
Radiological: Hypertrophy
Time frame: 3 months, 12 months, 36 months, 60 months, 120 months
Radiological: Loosening of the Implant or Migration
Time frame: 3 months, 12 months, 36 months, 60 months, 120 months

Results and safety

Results posted to the registry on 21 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total Hip Arthroplasty	218	94

Primary outcome: Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM

Time frame: Pre-operatively, 3 months, 12 months, 36 months, 60 months, and 120 months. Number (95% Confidence Interval). Unit: percentage of hips

Measure	Total Hip Arthroplasty n = 218
Pre-operatively	100
3 Months	99.6 (96.9 to 99.9)
12 Months	99.1 (96.5 to 99.8)
36 Months	98.7 (95.9 to 99.6)
60 Months	98.7 (95.9 to 99.6)
120 Months	98.7 (95.9 to 99.6)

Population analysed: All participants who received study treatment with data collected for the given outcome at the time point specified.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Surgery to End of Study visit, approximately 120 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Total Hip Arthroplasty	114 of 218 (52.3%)	115 of 218 (52.8%)	29 of 218

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31752951Cypres A, Fiquet A, Girardin P, Fitch D, Bauchu P, Bonnard O, Noyer D, Roy C. Long-term outcomes of a dual-mobility cup and cementless triple-taper femoral stem combination in total hip replacement: a multicenter retrospective analysis. J Orthop Surg Res. 2019 Nov 21;14(1):376. doi: 10.1186/s13018-019-1436-y.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis

Recruiting
Autologous Adipose-Derived Stem Cell Injections for Knee Osteoarthritis
Osteoarthritis, Knee
Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
Not yet recruiting
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Knee Osteoarthritis
RecruitingPhase 4
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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.

Turgay Efe, Dr.med. principal investigator

Philipps University Marburg

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, run by Smith & Nephew, Inc. at 3 sites in 2 countries.

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 5 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Switzerland. 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 21 Jan 2026). 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?

Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM (time frame: Pre-operatively, 3 months, 12 months, 36 months, 60 months, and 120 months). 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 NCT02648152, 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 21 Jan 2026.