Arthroplasty, Replacement, HipNCT01257568

Rejuvenate Modular Outcomes Study

A study testing Rejuvenate Modular Hip in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 3 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

This study will be an evaluation of the Rejuvenate® Modular Hip System for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthroplasty, Replacement, Hip
What is being tested?: Rejuvenate Modular Hip
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 3 sitesUnited States
Study dates: Nov 2010to 20 Jan 2022
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

Patient has signed an IRB approved, study specific Informed Patient Consent Form.
Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
Patient is a candidate for a primary cementless total hip replacement.
Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Patient's operative femur templates to Rejuvenate® Modular Stem size 7-12.

Who cannot join

Patient has a Body Mass Index (BMI) ≥ 40.
Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
Patient has a known sensitivity to device materials.
Patient is a prisoner.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Oakwood Healthcare
Dearborn, Michigan, 48124
St. Cloud Orthopaedics Associates
Sartell, Minnesota, 56377
The Orthopedic Center
Tulsa, Oklahoma, 74104

Other trials in United States

About this study

Official title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System

Conditions: Arthroplasty, Replacement, Hip
Being tested: Rejuvenate Modular Hip

What participants receive

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

Rejuvenate Modular HipDevice
Rejuvenate Modular Hip

Study groups in NCT01257568
Study group	Role	What they receive
Rejuvenate Modular Hip System	Other	Rejuvenate Modular Hip Receives: Device: Rejuvenate Modular Hip

What is being measured

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

Survival Rate of the Rejuvenate Modular Stem/Neck
The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.
Measured: 5 years postoperative

Secondary outcomes (7)

Biomechanical Measurement of Femoral Offset
Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters.
Measured: 6 weeks
Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation
Change from preoperative vertical distance of the anatomic hip center to the planned center of rotation of the hip to the postoperative distance from the planned center of rotation at 6 weeks measured in millimeters.
Measured: 6 weeks
Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation
Change from preoperative horizontal distance of the anatomic hip center to the planned center of rotation of the hip to the postoperative distance from the planned center of rotation at 6 weeks measured in millimeters.
Measured: 6 weeks
Mean Harris Hip Score at Each Visit
The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. 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 of 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, 6 wk, 1, 2, 3, 4, 5, 7 year
Mean SF-12 Scores at Each Visit
The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Measured: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Measured: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Radiographic stability of the stem is defined as having the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of great than or equal to 5 mm. Only subsidence was measured at 6 weeks, migration and fixation are analyzed beginning at 1 year postoperative.
Measured: 6 wks,1,2,3,4,5 yrs

Timeline

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

Nov 201020 Jan 2022

First posted9 Dec 2010 (estimated)
Study startNov 2010
Primary completion6 Jun 2017
Study completion20 Jan 2022

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: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01257568
Sponsor's protocol ID: 68
Status last verified: Feb 2022
First submitted: 8 Dec 2010
Last updated: 16 Feb 2022
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

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The restor3d Outcomes Registry
Joint Replacement, Arthropathy
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
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
Tau Pathology in the Brain After Hip or Knee Replacement Surgery
Postoperative Cognitive Dysfunction, Alzheimer Disease

All Arthroplasty, Replacement, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System
ClinicalTrials.gov ID: NCT01257568
Acronym / sponsor ID: 68
Conditions: Arthroplasty, Replacement, Hip
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Stryker OrthopaedicsIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: 6 Jun 2017 (actual)
Study completion: 20 Jan 2022 (actual)
First posted: 9 Dec 2010 (estimated)
Results: Posted 24 Jan 2019

Clinical summary

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

Study design

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

Arm	Type	Receives
Rejuvenate Modular Hip System	Other	Device: Rejuvenate Modular HipRejuvenate Modular Hip

Who may qualify

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

Key inclusion criteria (6 listed)

Patient has signed an IRB approved, study specific Informed Patient Consent Form.
Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
Patient is a candidate for a primary cementless total hip replacement.
Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Key exclusion criteria (8 listed)

Patient has a Body Mass Index (BMI) ≥ 40.
Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).

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
Rejuvenate Modular HipRejuvenate Modular Hip	Device	Rejuvenate Modular Hip System

Primary outcome

Survival Rate of the Rejuvenate Modular Stem/Neck
Time frame: 5 years postoperative
The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.

7 secondary outcomes

Biomechanical Measurement of Femoral Offset
Time frame: 6 weeks
Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation
Time frame: 6 weeks
Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation
Time frame: 6 weeks
Mean Harris Hip Score at Each Visit
Time frame: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
Mean SF-12 Scores at Each Visit
Time frame: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit
Time frame: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
Time frame: 6 wks,1,2,3,4,5 yrs

Results and safety

Results posted to the registry on 24 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rejuvenate Modular Hip System	40	7

Primary outcome: Survival Rate of the Rejuvenate Modular Stem/Neck

Time frame: 5 years postoperative. Number. Unit: Surviving Hips

Measure	Rejuvenate Modular Hip System n = 40
Value	8

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: To 10 years postoperative. All AEs that meet the definition of serious, excluding elective procedures, and all AEs related to the operative site, regardless of seriousness.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Operative Adverse Events	25 of 42 (59.5%)	9 of 42 (21.4%)	0 of 42
Non-Operative Adverse Events	4 of 40 (10%)	7 of 40 (17.5%)	0 of 40

Limitations and caveats (from the sponsor): Primary Outcome Note: Due to the large number of terminations and halting enrollment early in the study, the primary endpoint analysis will not be performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arthroplasty, Replacement, Hip

RecruitingObservational study
The restor3d Outcomes Registry
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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
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
Tau Pathology in the Brain After Hip or Knee Replacement Surgery
Postoperative Cognitive Dysfunction, Alzheimer Disease

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.

Yogesh Mittal, M.D. principal investigator

The Orthopedic Center

Joseph Nessler, M.D. principal investigator

St. Cloud Orthopaedic Associates

Lawrence Morawa, M.D. principal investigator

Oakwood Healthcare System

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

Questions about this trial

What is this clinical trial studying?

A study testing Rejuvenate Modular Hip in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 3 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 6 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 16 Feb 2022. 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 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 24 Jan 2019). 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?

Survival Rate of the Rejuvenate Modular Stem/Neck (time frame: 5 years postoperative). 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 NCT01257568.

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 16 Feb 2022.