Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty

• Sponsor: Hartford Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01114646
• Collaborator: Zimmer Biomet (Industry)
• Enrollment: 130
• Location: 1
• Arms: 2
• Duration (Months): 50
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

Hemiarthroplasty (half of a hip replacement) is the most common treatment for displaced fractures of the femoral neck in the elderly and is associated with a better functional outcome and fewer reoperations than internal fixation. Currently, the operative management of displaced femoral neck fractures favors the use of cemented implants. This technique is believed to be more stable in the immediate post-operative period, but there is limited evidence of a decreased morbidity and mortality with cemented versus press-fit stems (uncemented). In 2006, a meta-analysis concluded that the evidence was too limited to recommend a cemented or press-fit hemiarthroplasty.

In this investigation, the morbidity, mortality and functional outcome associated with cemented and press-fit hemiarthroplasty will be compared prospectively. We propose that the use of press-fit hemiarthroplasty in the treatment of displaced subcapital fractures of the femoral neck would be associated with a decreased risk of adverse peri-operative outcomes, and that the functional results of cemented and press-fit hemiarthroplasty will be equivalent at one year.

Condition or Disease	Intervention/Treatment	Phase
Femoral Neck Fracture	Device: Cemented Hip Hemiarthroplasty; Device: VerSys Beaded FullCoat, Zimmer	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Functional Status, Morbidity and Mortality in Cemented Versus Uncemented Hemiarthroplasty for Subcapital Hip Fractures: A Prospective Randomized Trial
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Cemented Hip Hemiarthroplasty This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).	Device: Cemented Hip Hemiarthroplasty; The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.
Experimental: Press-Fit Hip Hemiarthroplasty This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),	Device: VerSys Beaded FullCoat, Zimmer; The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,

Outcome Measures

Primary Outcome Measures

1. Mortality [1 year]

   Assessment of post-operative mortality at one-year.

2. Post-Operative Unstable Angina [1 week post-operation]

   Unstable angina was defined as the new onset of prolonged chest pain (greater than or equal to 30 minutes) or two episodes of chest pain thought to be of cardiac origin or an electrocardiogram showing new T-wave inversion, ST depression or elevation with enzymes non-diagnostic of myocardial ischemia.

3. Post-Operative Myocardial Infarction [1 week post-operation]

   Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.

Secondary Outcome Measures

1. Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) Scale [1 year]

   A modified version of the Older Americans Resources and Services Instrument (OARS) which asks about performance of tasks of daily living during the preceding two weeks.14 These activities include: getting to places, walking distances, shopping for groceries or clothes, preparing meals and doing housecleaning.

2. Energy/Fatigue Scale [1 year]

   An inquire about fatigue, level of energy and self-efficiency.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• older than 55 years

• non-pathologic, displaced subcapital femoral neck fracture

• designated for surgical reconstruction with a hemiarthroplasty by the attending surgeon

• able to ambulate ten feet prior to presentation

Exclusion Criteria:

• unable to walk ten feet prior to hip fracture

• multiple extremity trauma

• pathologic fracture of the hip (including malignancy)

• clinically recognized acute myocardial infarction within thirty days prior to enrollment

• previously participated in the trial

• symptoms associated with anemia

• pre-existing metabolic bone disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hartford Hospital	Hartford	Connecticut	United States	06106

Sponsors and Collaborators

• Hartford Hospital
• Zimmer Biomet

Investigators

• Study Director: Joseph P. DeAngelis, MD, Hartford Hospital
• Principal Investigator: Courtland G. Lewis, MD, Hartford Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hartford Hospital
• ClinicalTrials.gov Identifier: NCT01114646
• Other Study ID Numbers: 03001334HU; 124013
• First Posted: May 3, 2010
• Last Update Posted: Aug 7, 2018
• Last Verified: Mar 1, 2013

• Keywords provided by Hartford Hospital: Hemiarthroplasty; Cemented; Press Fit; Mortality; Morbidity; Functional Status; Displaced femoral neck fracture
• Additional relevant MeSH terms: Fractures, Bone; Femoral Neck Fractures

Study Results

Participant Flow

Arm/Group Title	Cemented Hip Hemiarthroplasty	Press-Fit Hip Hemiarthroplasty
Arm/Group Description	This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).	This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
Period Title: Overall Study
STARTED	66	64
COMPLETED	63	62
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Cemented Hip Hemiarthroplasty	Press-Fit Hip Hemiarthroplasty	Total
Arm/Group Description	This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).	This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),	Total of all reporting groups
Overall Participants	66	64	130
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	66 100%	64 100%	130 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	81.8 (9.0)	82.8 (7.6)	82.3 (8.3)
Sex: Female, Male (Count of Participants)
Female	52 78.8%	48 75%	100 76.9%
Male	14 21.2%	16 25%	30 23.1%
Region of Enrollment (participants) [Number]
United States	66 100%	64 100%	130 100%

Outcome Measures

1. Primary Outcome

Title	Mortality
Description	Assessment of post-operative mortality at one-year.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cemented Hip Hemiarthroplasty	Press-Fit Hip Hemiarthroplasty
Arm/Group Description	This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).	This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
Measure Participants	66	64
Number [pecent]	23.1	20.1

2. Primary Outcome

Title	Post-Operative Unstable Angina
Description	Unstable angina was defined as the new onset of prolonged chest pain (greater than or equal to 30 minutes) or two episodes of chest pain thought to be of cardiac origin or an electrocardiogram showing new T-wave inversion, ST depression or elevation with enzymes non-diagnostic of myocardial ischemia.
Time Frame	1 week post-operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Primary Outcome

Title	Post-Operative Myocardial Infarction
Description	Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.
Time Frame	1 week post-operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) Scale
Description	A modified version of the Older Americans Resources and Services Instrument (OARS) which asks about performance of tasks of daily living during the preceding two weeks.14 These activities include: getting to places, walking distances, shopping for groceries or clothes, preparing meals and doing housecleaning.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Energy/Fatigue Scale
Description	An inquire about fatigue, level of energy and self-efficiency.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days.
Adverse Event Reporting Description	other events such pneumonia, wound infection, thromboembolic event, cerebrovascular accident major hemorrhage will be assessed by concurrent medical record review. Hospital outcome will be assessed by surgical and medical team. Functional outcome will be completed over the telephone (self-reported)
Arm/Group Title	Cemented Hip Hemiarthroplasty		Press-Fit Hip Hemiarthroplasty
Arm/Group Description	This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).		This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
All Cause Mortality
	Cemented Hip Hemiarthroplasty		Press-Fit Hip Hemiarthroplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Cemented Hip Hemiarthroplasty		Press-Fit Hip Hemiarthroplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/66 (1.5%)		1/64 (1.6%)
Cardiac disorders
Death	1/66 (1.5%)		1/64 (1.6%)
Other (Not Including Serious) Adverse Events
	Cemented Hip Hemiarthroplasty		Press-Fit Hip Hemiarthroplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/66 (16.7%)		8/64 (12.5%)
Cardiac disorders
Myocardial Infarction	2/66 (3%)		1/64 (1.6%)
General disorders
ICU stay	4/66 (6.1%)		5/64 (7.8%)
Infections and infestations
Wound Infection	1/66 (1.5%)		1/64 (1.6%)
Respiratory, thoracic and mediastinal disorders
Pneumonia	3/66 (4.5%)		1/64 (1.6%)
Surgical and medical procedures
Re-operation	1/66 (1.5%)		0/64 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.