Osteoarthritis, HipNCT02851992

A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem

A study testing GTS cementless stem in people with Osteoarthritis, Hip, run by Zimmer Biomet.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is a multicenter, non-controlled, prospective study. 303 subjects (GTS standard and lateralized) have been recruited. Study will be conducted in centers across Europe. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Hip
What is being tested?: GTS cementless stem
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 303 participants
Where: No sites listed yet
Study dates: Sep 2012to May 2025
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients inclusion criteria for this evaluation are be in accordance with the indications of the GTS® stem and specifically
Primary osteoarthritis or secondary coxarthritis
Inflammation of the hip: rheumatoid arthritis, etc.
Femoral neck fracture
Avascular necroses of the femoral head
Sequelae from previous operations on the hip, osteotomies, etc.

Show all 11Show fewer

Congenital hip dysplasia
Additional inclusion criteria include:
18 years of age or older
Subjects willing to return for follow-up evaluations
Subjects who read, understood study information and provided an informed written consent (specific local regulatory requirements)

Who cannot join

Exclusion criteria are in accordance with absolute and relative contraindications for use for GTS® stem
Absolute contraindications include:
Local or systemic infections.
Severe muscular, neurological or vascular deficiencies of the extremity involved
Bone destruction or poor bone quality that is likely to affect implant stability(Paget's disease, osteoporosis, etc.)
Concomitant disease likely to affect implant function

Show all 13Show fewer

Allergy to any of the components of the implant
Patients weighing more than 110 kg
Additional exclusion criteria:
Subjects unable to co-operate with and complete the study
Dementia and/or inability to understand and follow instructions
Neurological conditions affecting movement
Patient over 18 under law supervision

About this study

This is a multicenter, non-controlled, prospective study. 303 subjects (GTS standard and lateralized) have been recruited. Study will be conducted in centers across Europe.

Read the detailed description

The objective of this prospective clinical study is to obtain multi-center, long-term (10-year) clinical data on the new GTS® femoral stem in its standard and lateralized versions as part of Post Market Surveillance requirements.

The initial study assessment period will be 12 years; 24 months recruitment and the follow-up clinical reviews for all patients will be at 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.

Conditions: Osteoarthritis, Hip
Being tested: GTS cementless stem
Medical subject headings: Osteoarthritis, Hip

What participants receive

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

GTS cementless stemDevice
Total Hip Arthroplasty

Study groups in NCT02851992
Study group	Role	What they receive
GTS cementless stem	Other	Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene) Receives: Device: GTS cementless stem

What is being measured

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

Mean Harris Hip Score
Harris Hip Score (HHS) tests will be carried out pre-operatively and at each follow-up period.
The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The minimum and maximum values of the scale are 0-100, with a higher score indicating a better outcome. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70.
Measured: Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-operatively.

Secondary outcomes (4)

Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
The presence or absence of the following femoral radiographic findings was assessed at the 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years post-surgery follow-up visit: subsidence of the stem, stem radiolucencies, calcar resorption, and heterotopic ossification.
Measured: 10 years post-surgery.
Patient Satisfaction
EQ-5D quality of life score will be taken at every follow-up clinic and by postal questionnaire when patients are not attending a clinic.
The EQ-5D is a standardized instrument widely used to measure health status. The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. Scores will be within the range of 0-1 with 1 corresponding to perfect health.
Measured: Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-surgery
Adverse Events/Complications
The number of revisions/removals, SAE's and deaths are listed.
Measured: From surgery through the 10-year post-operative follow-up period.
Revision-Free Survivorship Through 10 Years
Revision-free survivorship was defined as the number of participants who did not undergo revision or removal of any hip implant component from implantation through the 10-year post-operative follow-up period.
Measured: From implantation through 10 years post-operatively

Timeline

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

Sep 2012May 2025

First posted2 Aug 2016 (estimated)
Study startSep 2012
Primary completionMay 2020
Study completionMay 2025

Why it stopped: Zimmer Biomet is prioritizing specific products within its portfolio and has chosen not to extend the CE mark for the GTS stem under MDR requirements, leading to the premature termination of the GTS study in 2024.

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.
Other trials for Osteoarthritis, HipStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 303 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02851992
Sponsor's protocol ID: ORTHO.CR.H36
Status last verified: Jul 2026
First submitted: 25 Jul 2016
Last updated: 10 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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?

Official record

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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
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Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
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FRONT Block for Quality of Recovery After Total Hip Arthroplasty
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Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
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Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis

All Osteoarthritis, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
ClinicalTrials.gov ID: NCT02851992
Acronym / sponsor ID: ORTHO.CR.H36
Conditions: Osteoarthritis, Hip
Study type: Interventional
Recruitment status: TerminatedReason stopped: Zimmer Biomet is prioritizing specific products within its portfolio and has chosen not to extend the CE mark for the GTS stem under MDR requirements, leading to the premature termination of the GTS study in 2024.
Enrolment: 303 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Sep 2012 (actual)
Primary completion: May 2020 (actual)
Study completion: May 2025 (actual)
First posted: 2 Aug 2016 (estimated)
Results: Posted 1 Dec 2023

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 multicenter, non-controlled, prospective study. 303 subjects (GTS standard and lateralized) have been recruited. Study will be conducted in centers across Europe.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GTS cementless stem	Other	Device: GTS cementless stemTotal Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Patients inclusion criteria for this evaluation are be in accordance with the indications of the GTS® stem and specifically
Primary osteoarthritis or secondary coxarthritis
Inflammation of the hip: rheumatoid arthritis, etc.
Femoral neck fracture
Avascular necroses of the femoral head

Key exclusion criteria (13 listed)

Exclusion criteria are in accordance with absolute and relative contraindications for use for GTS® stem
Local or systemic infections.
Severe muscular, neurological or vascular deficiencies of the extremity involved
Bone destruction or poor bone quality that is likely to affect implant stability(Paget's disease, osteoporosis, etc.)
Concomitant disease likely to affect implant function

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
GTS cementless stemTotal Hip Arthroplasty	Device	GTS cementless stem

Primary outcome

Mean Harris Hip Score
Time frame: Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-operatively.
Harris Hip Score (HHS) tests will be carried out pre-operatively and at each follow-up period. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The minimum and maximum values of the scale are 0-100, with a higher score indicating a better outcome. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70.

4 secondary outcomes

Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling
Time frame: 10 years post-surgery.
Patient Satisfaction
Time frame: Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-surgery
Adverse Events/Complications
Time frame: From surgery through the 10-year post-operative follow-up period.
Revision-Free Survivorship Through 10 Years
Time frame: From implantation through 10 years post-operatively

Results and safety

Results posted to the registry on 1 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GTS Cementless Stem	303	41

Primary outcome: Mean Harris Hip Score

Time frame: Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-operatively.. Mean (Standard Deviation). Unit: Units on a scale

Measure	GTS Cementless Stem n = 280
Pre-operative	50.36 (15.93)
3 Months	85.7 (10.5)
1 Year	91.2 (7.2)
2 Year	91.9 (6.3)
3 Year	93.3 (2.0)
5 Year	92.8 (4.3)
7 Year	91.4 (6.8)
10 year post-operatively	92.7 (5.7)

Population analysed: The HHS was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a maximum of 100 points.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From implantation through 10 years post-operatively. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GTS Cementless Stem	12 of 281 (4.3%)	11 of 281 (3.9%)	5 of 281

Limitations and caveats (from the sponsor): The study was terminated prematurely, resulting in limited participant follow-up beyond 7 years and reduced long-term data availability.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis, Hip

Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
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
Recruiting
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Osteoarthritis of the Hip, Postoperative Pain
RecruitingObservational study
Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
Hip OA
Not yet recruitingObservational study
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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 study testing GTS cementless stem in people with Osteoarthritis, Hip, run by Zimmer Biomet.

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 11 inclusion and 13 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: stopped early, as of the sponsor's last update on 10 Aug 2026. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2023). 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?

Mean Harris Hip Score (time frame: Pre-operatively, 3 months and 1, 2, 3, 5, 7, and 10 years post-operatively.). 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 NCT02851992.

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 10 Aug 2026.