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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Osteoarthritis, Hip Traumatic Arthritis of Hip
Intervention:	Device: Answer® hip stem

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited by the investigator based on the FDA cleared inclusion/exclusion criteria in the protocol.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The patients were assigned to each group according to the bone cement used with the implant.

Reporting Groups

	Description
Answer Stem Utilizing Simplex Cement	Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
Answer Stem Utilizing Palacos Cement	Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.

Participant Flow for 8 periods

Period 1: Pre-Operative

	Answer Stem Utilizing Simplex Cement	Answer Stem Utilizing Palacos Cement
STARTED	202 ^[1]	200 ^[2]
COMPLETED	107	114
NOT COMPLETED	95	86
Patients Did Not Complete Preop Data	95	86

[1]	202 Patients were enrolled, however only 107 contributed preop data.
[2]	200 patients were enrolled, however only 114 contributed preop data.

Period 2: 6 Months

	Answer Stem Utilizing Simplex Cement	Answer Stem Utilizing Palacos Cement
STARTED	107 ^[1]	114 ^[2]
COMPLETED	9	41
NOT COMPLETED	98	73
Patients did not return for follow-up	98	73

[1]	107 cases were due at 6 Months, however only 9 returned for follow-up.
[2]	114 cases were due at 6 Months, however only 41 returned for follow-up.

Period 3: 1 Year

	Answer Stem Utilizing Simplex Cement	Answer Stem Utilizing Palacos Cement
STARTED	107 ^[1]	114 ^[2]
COMPLETED	18	32
NOT COMPLETED	89	82
Patients did not return for follow-up	89	82

[1]	107 cases were due at 1 Year, however only 18 returned for follow-up.
[2]	114 cases were due at 1 Year, however only 32 returned for follow-up.

Period 4: 2 Years

	Answer Stem Utilizing Simplex Cement	Answer Stem Utilizing Palacos Cement
STARTED	107 ^[1]	114 ^[2]
COMPLETED	15	27
NOT COMPLETED	92	87
Patients did not return for follow-up	92	87

[1]	107 cases were due at 2 Years, however only 15 returned for follow-up.
[2]	114 cases were due at 2 Years, however only 27 returned for follow-up.

Period 5: 4 Years

	Answer Stem Utilizing Simplex Cement	Answer Stem Utilizing Palacos Cement
STARTED	107 ^[1]	114 ^[2]
COMPLETED	16	11
NOT COMPLETED	91	103
Patients did not return for follow-up	91	103

[1]	107 cases were due at 4 Years, however only 16 returned for follow-up.
[2]	114 cases were due at 4 Years, however only 11 returned for follow-up.

Period 6: 6 Years

	Answer Stem Utilizing Simplex Cement	Answer Stem Utilizing Palacos Cement
STARTED	107 ^[1]	114 ^[2]
COMPLETED	3	5
NOT COMPLETED	104	109
Patients did not return for follow-up	104	109

[1]	107 cases were due at 6 Years, however only 3 returned for follow-up.
[2]	114 cases were due at 6 Years, however only 5 returned for follow-up.

Period 7: 8 Years

	Answer Stem Utilizing Simplex Cement	Answer Stem Utilizing Palacos Cement
STARTED	107 ^[1]	114 ^[2]
COMPLETED	2	0
NOT COMPLETED	105	114
Patients did not return for follow-up	105	114

[1]	107 cases were due at 8 Years, however only 2 returned for follow-up.
[2]	114 cases were due at 8 Years, however no patients returned for follow-up.

Period 8: 10 Years

	Answer Stem Utilizing Simplex Cement	Answer Stem Utilizing Palacos Cement
STARTED	107 ^[1]	114 ^[2]
COMPLETED	0	0
NOT COMPLETED	107	114
Incomplete due to study termination	107	114

[1]	107 cases were due at 10 Years, however no patients returned for follow-up.
[2]	114 cases were due at 10 Years, however no patients returned for follow-up.

Baseline Characteristics

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Reporting Groups

	Description
Answer Stem Utilizing Simplex Cement	Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
Answer Stem Utilizing Palacos Cement	Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.

Baseline Measures

	Answer Stem Utilizing Simplex Cement	Answer Stem Utilizing Palacos Cement	Total
Number of Participants [units: participants]	202	200	402
Age [units: years] Mean ( Full Range )	73 ( 46 to 93 )	76 ( 54 to 95 )	75 ( 46 to 95 )
Gender [units: participants]
Female	127	142	269
Male	75	58	133

Outcome Measures

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1. Primary:

Harris Hip Score [ Time Frame: 10 Years Post-Operative ]

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2. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The only disclosure restriction on the PI is that the sponsor can conduct a pre-publication review of articles, papers, or presentations which the PI desires to publish. Any such review must be completed by sponsor within thirty (30)days of the submission of the request. The PI must include whatever credits the sponsor deems necessary or appropriate to disclose its proprietary interest to the material disclosed in the article, paper or presentation.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated prematurely after sponsor no longer distributed the products involved and follow-up failed to produce sufficient data to be analyzed.

Results Point of Contact:

Name/Title: Nick Higdon, Clinical Research Specialist
Organization: Biomet Manufacturing
phone: 1-800-348-9500 ext 3047
e-mail: nicholas.higdon@biomet.com

No publications provided

Responsible Party:	Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:	NCT00588861 History of Changes
Other Study ID Numbers:	101-U-011
Study First Received:	December 19, 2007
Results First Received:	June 14, 2010
Last Updated:	January 12, 2012
Health Authority:	United States: Institutional Review Board