Arthroplasty, Replacement, HipNCT00962013

Restoration® Modular Revision Hip System Post Market Study

A study testing Restoration® Modular Revision Hip System in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 13 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Arthroplasty, Replacement, Hip
What is being tested?: Restoration® Modular Revision Hip System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 13 sitesUnited States
Study dates: Jan 2004to Dec 2011
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Candidates for cementless revision of a failed femoral prosthesis.
Patients willing to sign the informed consent.
Patients able to comply with follow-up requirements including post-operative weightbearing restrictions and self-evaluations.
Male and non-pregnant female patients ages 18 to 85 years of age at the time of surgery.

Who cannot join

Patients with ongoing infection.
Patients who are severely immunocompromised.
Patients who are prisoners.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Crystal Clinic
Akron, Ohio, 44333
Orthopedic Associates of Corpus Christi
Corpus Christi, Texas, 78411
Iowa Orthopaedic Center
Des Moines, Iowa, 50314
New West Sports Medicine and Orthopaedic Surgery
Kearney, Nebraska, 68847
Jewish Hospital Center for Advanced Medicine
Louisville, Kentucky, 40202
Hospital for Joint Diseases
New York, New York, 10003
Beth Israel Medical Center
New York, New York, 10021
Orthopaedic Specialty Institute
Orange, California, 92868
Rothman Institute
Philadelphia, Pennsylvania, 19107
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Orthopaedic Specialities
Spokane, Washington, 99204
Scott and White Hospital
Temple, Texas, 76508
Kansas Joint and Spine Institute
Wichita, Kansas, 67226

Other trials in United States

About this study

Official title: A Prospective Open-Label Evaluation of the Restoration® Modular System

The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.

Read the detailed description

The two-piece modular revision stem components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. This study evaluates the System in revision cases only. The stems are intended to be used with Stryker Orthopaedics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.

In addition to demonstrating survivorship at 5 years, this study will seek to gain information on four secondary objectives: radiographic stability, Harris Hip Scores, SF-36 general well-being assessment, and safety profile.

Conditions: Arthroplasty, Replacement, Hip
Being tested: Restoration® Modular Revision Hip System

What participants receive

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

Restoration® Modular Revision Hip SystemDevice
Restoration® Modular Revision System

Study groups in NCT00962013
Study group	Role	What they receive
Restoration® Modular	Other	All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant. Receives: Device: Restoration® Modular Revision Hip System

What is being measured

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

Stem Survivorship (%)
Failure is defined by stem revision for any cause.
Measured: 5 years
Femoral Stem Fracture
Measured: 5 years

Secondary outcomes (4)

Radiographic Stability
Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view.
Measured: 5 years
Harris Hip Score
Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.
90 - 100 = excellent
80 - 89 = good
70 - 79 = fair
0 - 69 = poor
Measured: pre-op and 5 years
SF-36 Health Status Survey: Role - Physical
Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state:
The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health
This Secondary Outcome Measure is focused on the "Role-Physical" score.
Measured: pre-op, 2 year and 5 year
Post-surgery Femoral Crack/Fracture and Subsidence Rate
Measured: Post-op to 5 years

Timeline

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

Jan 2004Dec 2011

First posted19 Aug 2009 (estimated)
Study startJan 2004
Primary completionDec 2011
Study completionDec 2011

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 Arthroplasty, Replacement, 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00962013
Sponsor's protocol ID: 53
Status last verified: Feb 2017
First submitted: 13 Aug 2009
Last updated: 29 Mar 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

RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
RecruitingPhase 4
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
Pain, Postoperative, Muscle Weakness
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
Not yet recruitingObservational study
Carotid Ultrasound for Post-Spinal Anesthesia Hypotension in Elderly Hip Surgery
Hypotension After Spinal Anesthesia

All Arthroplasty, Replacement, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Open-Label Evaluation of the Restoration® Modular System
ClinicalTrials.gov ID: NCT00962013
Acronym / sponsor ID: 53
Conditions: Arthroplasty, Replacement, Hip
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: Stryker OrthopaedicsIndustry (pharma, biotech, devices)
Study start: Jan 2004
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 19 Aug 2009 (estimated)
Results: Posted 15 Aug 2014

Clinical summary

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

The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.

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
Restoration® Modular	Other	Device: Restoration® Modular Revision Hip SystemAll subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Candidates for cementless revision of a failed femoral prosthesis.
Patients willing to sign the informed consent.
Patients able to comply with follow-up requirements including post-operative weightbearing restrictions and self-evaluations.
Male and non-pregnant female patients ages 18 to 85 years of age at the time of surgery.

Key exclusion criteria (3 listed)

Patients with ongoing infection.
Patients who are severely immunocompromised.
Patients who are prisoners.

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
Restoration® Modular Revision Hip SystemRestoration® Modular Revision System	Device	Restoration® Modular

Primary outcome

Stem Survivorship (%)
Time frame: 5 years
Failure is defined by stem revision for any cause.
Femoral Stem Fracture
Time frame: 5 years

4 secondary outcomes

Radiographic Stability
Time frame: 5 years
Harris Hip Score
Time frame: pre-op and 5 years
SF-36 Health Status Survey: Role - Physical
Time frame: pre-op, 2 year and 5 year
Post-surgery Femoral Crack/Fracture and Subsidence Rate
Time frame: Post-op to 5 years

Results and safety

Results posted to the registry on 15 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Restoration® Modular	120	52

Primary outcome: Stem Survivorship (%)

Time frame: 5 years. Number (90% Confidence Interval). Unit: stem survivorship percentage at 5 years

Measure	Restoration® Modular n = 55
Value	94.64 (89.69 to 99.59)

Restoration® Modular: p = 0.0136, Exact Binomial

Population analysed: Participants with 5 year follow-up evaluations or participant had a stem revision before they reached 5 years.

Primary outcome: Femoral Stem Fracture

Time frame: 5 years. Number. Unit: femoral stem fractures

Measure	Restoration® Modular n = 120
Value	0

Population analysed: Participants who received the Restoration Modular Hip System.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Enrollment to 5 years post-op. Censored protocol violations not included as at risk participants. Industry standard Adverse Event (AE) terms (e.g. MedDRA) were not used for AE data collection. Specific AE terms were not used for all AEs collected.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Restoration® Modular	44 of 120 (36.7%)	44 of 120 (36.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arthroplasty, Replacement, Hip

RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
RecruitingPhase 4
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
Pain, Postoperative, Muscle Weakness
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
Not yet recruitingObservational study
Carotid Ultrasound for Post-Spinal Anesthesia Hypotension in Elderly Hip Surgery
Hypotension After Spinal Anesthesia

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.

Steven Barnett, MD principal investigator

Orthopaedic Specialty Institute

Michael W Britt, MD principal investigator

Orthopaedic Associates of Corpus Christi

Kenneth A Greene, MD principal investigator

Crystal Clinic

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Restoration® Modular Revision Hip System in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 13 sites 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 3 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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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 15 Aug 2014). 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?

Stem Survivorship (%) (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT00962013.

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 29 Mar 2017.