OsteoarthritisSPDNCT00306917

Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement

A study testing non-coated femoral hip stem and coated femoral hip stem in people with Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics 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

Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty Read more about this study

Who is it for?: Ages Up to 75 years
Conditions the study is for: Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
What is being tested?: non-coated femoral hip stem and coated femoral hip stem
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 245 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2002to 29 Jan 2009
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 Up to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Primary total hip replacement
Patient age less than or equal to 75
Sufficient bone stock to support prosthesis

Who cannot join

Previous hip replacement
Significant angular/bony deformity
Active joint sepsis
Metal allergy
Renal transplant
Psychosocial disease
Neurological disease/musculoskeletal disease that may affect weight-bearing

Trial locations and contacts

1 site in 1 country.

United States1 site

DePuy Orthopaedics
Warsaw, Indiana, 46581

Other trials in United States

About this study

Official title: A Prospective, Randomized Study of Summit™ Porocoat® Versus Summit™ DuoFix™ HA in Cementless Total Hip Arthroplasty

Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty

Read the detailed description

Hydroxyapatite (HA) is a bioactive ceramic that resembles the natural inorganic mineral content of bone, and as such is a highly osteoconductive material. The purpose of this study is to compare an HA coated and uncoated prosthesis.

Conditions: Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Avascular Necrosis, Acute Fracture
Being tested: non-coated femoral hip stem, coated femoral hip stem
Keywords: Total Hip Replacement
Medical subject headings: Osteoarthritis, Arthritis, Rheumatoid, Osteonecrosis

What participants receive

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

non-coated femoral hip stemDevice
Also called Summit DuoFix HA hip stem
total hip replacement
coated femoral hip stemDevice
Also called Summit Porocoated porous coated hip stem.
total hip replacement

Study groups in NCT00306917
Study group	Role	What they receive
1	Active comparator	DuoFix HA Receives: Device: non-coated femoral hip stem
2	Active comparator	Porocoat porous coated Receives: Device: coated femoral hip stem

What is being measured

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

Harris Hip Score (HHS)
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction.
Measured: Preoperative, 6, 12, 24, 36, 48, and 60 months

Secondary outcomes (1)

Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure.
Medical imaging as a secondary outcome inclusive of all post-operative intervals for all participants at study closure. This measure is a percentage of the overall Participants with a specific radiographic outcome. Measurements were made by an Independent Radiographic Reviewer (IRR) and include assessments made based on protocol defined radiographic success criteria that includes Subsidence (10 mm), Osseointegration, Radiolucency > 2 mm in any zone, Complete Circumferential Radiolucencies, Spot-Welds (AP View) p < .10, Spot-Welds (Lateral View) p < .10, Cortical Hypertrophy (AP View), Cortical Hypertrophy (Lateral View)
Measured: Postoperative, 6, 12, 24, 36, 48 and 60 months

Timeline

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

1 Nov 200229 Jan 2009

First posted27 Mar 2006 (estimated)
Study start1 Nov 2002
Primary completion29 Jan 2009
Study completion29 Jan 2009

Why it stopped: Terminated due to limited enrollment and 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 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 245 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00306917
Sponsor's protocol ID: SPD
Acronym: SPD
Status last verified: Jun 2022
First submitted: 23 Mar 2006
Last updated: 19 Jul 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

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee

All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized Study of Summit™ Porocoat® Versus Summit™ DuoFix™ HA in Cementless Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT00306917
Acronym / sponsor ID: SPD / SPD
Conditions: Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Avascular Necrosis, Acute Fracture
Keywords: Total Hip Replacement
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to limited enrollment and follow up.
Enrolment: 245 participants (actual)
Lead sponsor: DePuy OrthopaedicsIndustry (pharma, biotech, devices)
Study start: 1 Nov 2002 (actual)
Primary completion: 29 Jan 2009 (actual)
Study completion: 29 Jan 2009 (actual)
First posted: 27 Mar 2006 (estimated)
Results: Posted 10 Mar 2010

Clinical summary

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

Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Device: non-coated femoral hip stemDuoFix HA
2	Active comparator	Device: coated femoral hip stemPorocoat porous coated

Who may qualify

Ages: Up to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Primary total hip replacement
Patient age less than or equal to 75
Sufficient bone stock to support prosthesis

Key exclusion criteria (7 listed)

Previous hip replacement
Significant angular/bony deformity
Active joint sepsis
Metal allergy
Renal transplant

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
non-coated femoral hip stemAlso: Summit DuoFix HA hip stemtotal hip replacement	Device	1
coated femoral hip stemAlso: Summit Porocoated porous coated hip stem.total hip replacement	Device	2

Primary outcome

Harris Hip Score (HHS)
Time frame: Preoperative, 6, 12, 24, 36, 48, and 60 months
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction.

1 secondary outcome

Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure.
Time frame: Postoperative, 6, 12, 24, 36, 48 and 60 months

Results and safety

Results posted to the registry on 10 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DuoFix HA	121	13
Porocoat Porous Coated	124	15

Primary outcome: Harris Hip Score (HHS)

Time frame: Preoperative, 6, 12, 24, 36, 48, and 60 months. Mean (Standard Deviation). Unit: Units on a scale

Measure	DuoFix HA n = 121	Porocoat Porous Coated n = 124
Preoperative HHS	49.9 (13.4)	51.2 (14.0)
Postoperative to 6 Month HHS	90.2 (10.3)	91.6 (8.3)
12 Month HHS	92.8 (7.9)	92.3 (11.6)
24 Month HHS	93.3 (7.8)	93.5 (9.7)
36 Month HHS	94.0 (8.5)	93.8 (9.4)
48 Month HHS	91.8 (12.2)	95.5 (10.5)
60 Month HHS	93.8 (7.9)	93.6 (7.8)

Population analysed: Before the first interval there were five missing HHS scores for the DuoFix arm and four missing HHS scores for the Porocoat Porous Coated arm. At the final interval (60 months), there were eleven subjects in the DuoFix arm with complete HHS scores and there were fourteen subjects in the Porocoat Porous Coated arm with complete HHS scores.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DuoFix HA	3 of 121 (2.5%)	6 of 121 (5%)	Not reported
Porocoat Porous Coated	4 of 124 (3.2%)	7 of 124 (5.6%)	Not reported

Limitations and caveats (from the sponsor): The protocol called for 400 subjects to be followed for 5 years, but due to slow enrollment the study closed early. 245 subjects were enrolled \& study endpoint was modified to 2 years. Enrollment closed on June 30, 2006; study closed on Jan 29, 2009.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee

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.

David A Fisher, MD principal investigator

Orthopaedics Indianapolis

J W Mesko, MD principal investigator

Michigan Orthopaedics Center

Paul Perona, MD principal investigator

St Margaret's Hospital Family Orthopaedics

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

Questions about this trial

What is this clinical trial studying?

A study testing non-coated femoral hip stem and coated femoral hip stem in people with Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics 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 3 inclusion and 7 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 19 Jul 2022. 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 10 Mar 2010). 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 (HHS) (time frame: Preoperative, 6, 12, 24, 36, 48, and 60 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 NCT00306917.

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 19 Jul 2022.