Osteoarthritis, HipNCT00588861

Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement

A study testing Answer® hip stem in people with Osteoarthritis, Hip and Traumatic Arthritis of Hip, run by Biomet Orthopedics, LLC at 1 site in United States.

Terminated

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

Official record

Search all trials

Trial summary

The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Hip, Traumatic Arthritis of Hip
What is being tested?: Answer® hip stem
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 siteUnited States
Study dates: Sep 2002to May 2010
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

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

Who cannot join

Infection, sepsis, and osteomyelitis

Trial locations and contacts

1 site in 1 country.

United States1 site

Biomet Orthopedics, LLC
Warsaw, Indiana, 46581

Other trials in United States

About this study

Official title: Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Acetabular Shell Using Simplex® or Palacos® Bone Cement

Read the detailed description

Conditions: Osteoarthritis, Hip, Traumatic Arthritis of Hip
Being tested: Answer® hip 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.

Answer® hip stemDevice
Also called Answer Hip Stem, Simplex Bone Cement
Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
Answer® hip stemDevice
Also called Answer Hip Stem, Palacos Bone Cement
Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.

Study groups in NCT00588861
Study group	Role	What they receive
Answer® hip stem with Simplex Cement	Active comparator	Femoral stem replacement with Answer® hip stem \& Simplex Bone Cement Receives: Device: Answer® hip stem
Answer® hip stem with Palacos Cement	Active comparator	Femoral stem replacement with Answer® hip stem \& Palacos Bone Cement Receives: Device: Answer® hip stem

What is being measured

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

Harris Hip Score
The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor."
Measured: 10 Years Post-Operative

Secondary outcomes (1)

Harris Hip Score Pain
Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered "None/Ignores." 40 is considered "Slight/Occasional." 30 is considered "Mild." 20 is considered "Moderate." 10 is considered "Marked." 0 is considered "Totally Disabled."
Measured: Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year

Timeline

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

Sep 2002May 2010

First posted9 Jan 2008 (estimated)
Study startSep 2002
Primary completionMay 2010
Study completionMay 2010

Why it stopped: Study was terminated due to insufficient data and lack of patient follow-up

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.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00588861
Sponsor's protocol ID: 101-U-011
Status last verified: Jan 2012
First submitted: 19 Dec 2007
Last updated: 27 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

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
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 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Acetabular Shell Using Simplex® or Palacos® Bone Cement
ClinicalTrials.gov ID: NCT00588861
Acronym / sponsor ID: 101-U-011
Conditions: Osteoarthritis, Hip, Traumatic Arthritis of Hip
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated due to insufficient data and lack of patient follow-up
Enrolment: 400 participants (actual)
Lead sponsor: Biomet Orthopedics, LLCIndustry (pharma, biotech, devices)
Study start: Sep 2002
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 9 Jan 2008 (estimated)
Results: Posted 26 Jan 2012

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Answer® hip stem with Simplex Cement	Active comparator	Device: Answer® hip stemFemoral stem replacement with Answer® hip stem \& Simplex Bone Cement
Answer® hip stem with Palacos Cement	Active comparator	Device: Answer® hip stemFemoral stem replacement with Answer® hip stem \& Palacos Bone Cement

Who may qualify

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

Key inclusion criteria (4 listed)

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

Key exclusion criteria (1 listed)

Infection, sepsis, and osteomyelitis

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
Answer® hip stemAlso: Answer Hip Stem, Simplex Bone CementTotal hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.	Device	Answer® hip stem with Palacos Cement, Answer® hip stem with Simplex Cement
Answer® hip stemAlso: Answer Hip Stem, Palacos Bone CementTotal hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.	Device	Answer® hip stem with Palacos Cement, Answer® hip stem with Simplex Cement

Primary outcome

Harris Hip Score
Time frame: 10 Years Post-Operative
The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor."

1 secondary outcome

Harris Hip Score Pain
Time frame: Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year

Results and safety

Results posted to the registry on 26 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Answer Stem Utilizing Simplex Cement	202	107
Answer Stem Utilizing Palacos Cement	200	114

Primary outcome: Harris Hip Score

Time frame: 10 Years Post-Operative

Population analysed: This population represents patients that returned for follow-up per protocol. Because no patients returned at the primary outcome measure time frame (10 years), 0 patients were analyzed at 10 years.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 8 Years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Answer Stem Utilizing Simplex Cement	15 of 202 (7.4%)	0 of 202 (0%)	Not reported
Answer Stem Utilizing Palacos Cement	8 of 200 (4%)	0 of 200 (0%)	Not reported

Limitations and caveats (from the sponsor): Study was terminated prematurely after sponsor no longer distributed the products involved and follow-up failed to produce sufficient data to be analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip 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.

Ken Beres, MD 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 Answer® hip stem in people with Osteoarthritis, Hip and Traumatic Arthritis of Hip, run by Biomet Orthopedics, LLC at 1 site in United States.

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 4 inclusion and 1 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 27 Jan 2017. 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 United States. 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 26 Jan 2012). 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?

Harris Hip Score (time frame: 10 Years Post-Operative). 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 NCT00588861.

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 27 Jan 2017.