NCT00746616

CompletedPhase 3

Durom(R) Hip Resurfacing System Multicenter Trial

Zimmer Biomet Source

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Other study identifiers

Sponsor study identifier

06-100

Secondary identifiers

G060120/S6

Study Type

interventional

Actual enrollment (reported)

40

Locations

1 country

Sites

5

Timeline

Study Start

June 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2011

Actual (reported)

Study Completion

March 2011

Actual (reported)

Brief Summary

The purpose of the study is to gather clinical information on the safety and efficacy of the resurfacing devices in the young, active patient with advanced hip disease. Study enrollment has been temporarily suspended due to a change in the surgical technique.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 40 participants
Study completion date: March 2011
Actual (reported)
Listed locations: 1 countries · 5 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 2, 2008
Actual (reported)
First Posted
September 4, 2008
Actual (reported)
Primary Completion
March 2011
Actual (reported)
Study Completion
March 2011
Actual (reported)

Last Updated: April 10, 2013
Status Verified: April 2013
Last Update Submitted: April 2, 2013

Conditions

Advanced Hip Disease

Keywords

Total Hip Arthroplasty,Acetabular Cup,Hip ResurfacingYoung,activepatients

Outcome Measures

Primary Outcomes (1)

Device Survival
All post-op visits until last patient enrolled reaches 2 year follow-up

Secondary Outcomes (1)

Efficacy
6 month post-op and annually until last patient reaches 2 year follow-up

Study Arms (1)

1

EXPERIMENTAL

Hip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty.

Device: Durom Hip Resurfacing System

Interventions

Durom Hip Resurfacing SystemDevice

Hip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty.

Also known as: Hip Reserfacing

1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient selection without bias to race or gender
Patient is greater than or equal to 18 and less than or equal to 65 years of age.

Sponsors & Collaborators

Zimmer Biomet
Industrylead

Study Sites (5)

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Syracuse Orthopedic Specialists

De Witt, New York, 13214, United States

Eastern Oklahoma Orthopedic Center

Tulsa, Oklahoma, 74136, United States

PENN Orthopedics

Philadelphia, Pennsylvania, 19107, United States

Texas Hip and Knee

Fort Worth, Texas, 76104, United States

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 4, 2008

Study Start

June 2007

Date type not reported

This date has not been verified as actual or estimated.

Female patients only:

actively practicing a contraceptive method, or

surgically sterilized, or

post-menopausal

Pre-operative Harris Hip Score less than or equal to 70.

Primary surgical hip candidate, suffering from hip pain and/or disability due to degenerative joint disease (inflammatory or non-inflammatory), based on physical examination and history, including the following diagnosis:

non-inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis or osteoarthritis

inflammatory joint disease (IJD), e.g. rheumatoid arthritis

Patient is willing and able to cooperate in prescribed post-operative therapy.

Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.

Patient has participated in the Informed Consent process and has signed and IRB approved Informed Consent.

You may not qualify if:

Patient with an acute, chronic, local or systemic infection.
Patient who is skeletally immature.
Patient with a severe muscular, neural or vascular disease that endangers the involved extremity.
Patient with an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible, including but not limited to:
patient with severe osteopenia
patients with a family history of severe osteoporosis or osteopenia
patients with osteonecrosis or avascular necrosis (AVN) with \> 50% involvement of the femoral head (regardless of FICAT grade)
patients with multiple cysts of the femoral head \> 1cm
Patient with total or partial absence of the muscular of ligamentous apparatus.
Patient has known moderate to severe renal insufficiency.
Patient with a known clinical condition which may interfere with patient outcome, including but not limited to:
immuno-compromised conditions (AIDS),
organ transplant recipient,
high doses of corticosteroids etc
Patient who is severely overweight (BMI \>40)
+9 more criteria

Contact the study team to confirm eligibility.

Primary Completion

March 2011

Actual (reported)

Study Completion

March 2011

Actual (reported)

Last Updated

April 10, 2013

Record last verified: 2013-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00746616
Data provider: ClinicalTrials.gov
Source updated: 2013-04-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:50 UTC

Locations

US(5)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations