Trial Outcomes & Findings for Omnifit Hydroxylapatite (HA) Hip Outcomes Study (NCT NCT00958347)

NCT ID: NCT00958347

Last Updated: 2014-08-19

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 226 participants
• Primary outcome timeframe: 25 Years Post-Operatively
• Results posted on: 2014-08-19

Participant Flow

226 participants = 262 hips

Participant milestones

Measure	Omnifit HA Hip Stem Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem.
Overall Study STARTED	226
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	226

Reasons for withdrawal

Measure	Omnifit HA Hip Stem Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem.
Overall Study Death	43
Overall Study Withdrawal by Subject	23
Overall Study Lost to Follow-up	15
Overall Study revision/removal	10
Overall Study study termination	135

Baseline Characteristics

Omnifit Hydroxylapatite (HA) Hip Outcomes Study

Baseline characteristics by cohort

Measure	Omnifit HA Hip Stem n=226 Participants Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
Age, Continuous	51.55 years STANDARD_DEVIATION 10.83 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants
Sex: Female, Male Male	113 Participants n=5 Participants

PRIMARY outcome

Timeframe: 25 Years Post-Operatively

Population: The study was closed and no subjects reached the 25 year postoperative endpoint.

Outcome measures

Outcome data not reported

Adverse Events

Omnifit HA Hip Stem

Serious events: 104 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Measure	Omnifit HA Hip Stem n=226 participants at risk Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
Cardiac disorders Non-operative Site Cardiac Disorders	5.8% 13/226 • Number of events 13 • 22 years Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
Gastrointestinal disorders Non-operative Site Gastrointestinal Disorders	0.44% 1/226 • Number of events 1 • 22 years Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
Infections and infestations Non-operative Site Infections and Infestations	0.88% 2/226 • Number of events 2 • 22 years Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
Infections and infestations Operative Site Infection and Infestation	0.88% 2/226 • Number of events 3 • 22 years Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
Musculoskeletal and connective tissue disorders Non-operative Site Musculoskeletal and Connective Tissue Disorders	4.0% 9/226 • Number of events 9 • 22 years Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
Musculoskeletal and connective tissue disorders Operative Site Musculoskeletal and Connective Tissue Disorders	35.8% 81/226 • Number of events 122 • 22 years Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Operative Site Neoplasms Benign,Malignant,and Unspecified	3.1% 7/226 • Number of events 7 • 22 years Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
Renal and urinary disorders Non-operative Site Renal and Urinary Disorders	0.44% 1/226 • Number of events 1 • 22 years Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
Skin and subcutaneous tissue disorders Operative Site Skin and Subcutaneous Tissue Disorders	0.44% 1/226 • Number of events 1 • 22 years Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
Vascular disorders Non-operative Site Vascular Disorders	4.0% 9/226 • Number of events 9 • 22 years Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.

Other adverse events

Measure	Omnifit HA Hip Stem n=226 participants at risk Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
Musculoskeletal and connective tissue disorders Non-operative Site Musculoskeletal and Connective Tissue Disorder	8.4% 19/226 • Number of events 26 • 22 years Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.
Musculoskeletal and connective tissue disorders Operative Site Musculoskeletal and Connective Tissue Disorder	26.1% 59/226 • Number of events 75 • 22 years Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract \& intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, \& mid-foot/flat-foot surgeries.

Additional Information

Director of Clinical Research

Stryker Orthopaedics

Phone: 201-831-5401

Email: ellen.axelson@stryker.com

Results disclosure agreements

• Principal investigator is a sponsor employee For 7 years from and after termination date of the agreement, prior to submission for publication of abstracts, manuscripts, presentations or other communications describing the results of any aspect of the Study ("Manuscript"), You and the Institution shall send Stryker Orthopaedics a copy of the Manuscript to be submitted, and allow Stryker Orthopaedics sixty (60) days from the date of receipt to review the Manuscript.
• Publication restrictions are in place

Restriction type: OTHER