Trial Outcomes & Findings for Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty (NCT NCT01114646)

NCT ID: NCT01114646

Last Updated: 2018-08-07

Results Overview

Assessment of post-operative mortality at one-year.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 130 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2018-08-07

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Cemented Hip Hemiarthroplasty This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).	Press-Fit Hip Hemiarthroplasty This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cemented Hip Hemiarthroplasty n=66 Participants This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).	Press-Fit Hip Hemiarthroplasty n=64 Participants This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),	Total n=130 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	66 Participants n=5 Participants	64 Participants n=7 Participants	130 Participants n=5 Participants
Age, Continuous	81.8 years STANDARD_DEVIATION 9.0 • n=5 Participants	82.8 years STANDARD_DEVIATION 7.6 • n=7 Participants	82.3 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	48 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	66 participants n=5 Participants	64 participants n=7 Participants	130 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Assessment of post-operative mortality at one-year.

Outcome measures

Measure	Cemented Hip Hemiarthroplasty n=66 Participants This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).	Press-Fit Hip Hemiarthroplasty n=64 Participants This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
Mortality	23.1 pecent	20.1 pecent

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 week post-operation

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Outcome data not reported

Adverse Events

Cemented Hip Hemiarthroplasty

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Press-Fit Hip Hemiarthroplasty

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cemented Hip Hemiarthroplasty n=66 participants at risk This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).	Press-Fit Hip Hemiarthroplasty n=64 participants at risk This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
Cardiac disorders Death	1.5% 1/66 • Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days. 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)	1.6% 1/64 • Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days. 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)

Other adverse events

Measure	Cemented Hip Hemiarthroplasty n=66 participants at risk This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).	Press-Fit Hip Hemiarthroplasty n=64 participants at risk This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
General disorders ICU stay	6.1% 4/66 • Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days. 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)	7.8% 5/64 • Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days. 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)
Respiratory, thoracic and mediastinal disorders Pneumonia	4.5% 3/66 • Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days. 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)	1.6% 1/64 • Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days. 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)
Cardiac disorders Myocardial Infarction	3.0% 2/66 • Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days. 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)	1.6% 1/64 • Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days. 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)
Infections and infestations Wound Infection	1.5% 1/66 • Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days. 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)	1.6% 1/64 • Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days. 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)
Surgical and medical procedures Re-operation	1.5% 1/66 • Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days. 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)	0.00% 0/64 • Post-randomization unstable angina, MI during the index hospitalization or death for any reason within 30 days. 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)

Additional Information

Arben Ademi, CCRP

Hartford Hostpial

Phone: 860-972-3561

Email: arben.ademi@hhcealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place