Trial Outcomes & Findings for A Clinical Trial of a Metal on Poly Component Versus CORAIL Stem: A Bone Mineral Density Study (NCT NCT01558752)

Results Overview

To prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling for the 2 groups. Bone mineral density was assessed using high-sensitivity dual x-ray absorptiometry region-free analysis (DXA-RFA). Mean number of pixels with change with significant BMD decrease.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

88 participants

Primary outcome timeframe

2 Years Post-operative

Results posted on

2020-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Corail Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem. Total hip replacement with titanium shell and CORAIL stem: Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion).	Tri-Lock Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock). Total hip replacement with Modular Titanium Femoral Stem: Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert).
Overall Study STARTED	42	46
Overall Study COMPLETED	40	46
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Corail Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem. Total hip replacement with titanium shell and CORAIL stem: Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion).	Tri-Lock Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock). Total hip replacement with Modular Titanium Femoral Stem: Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert).
Overall Study Physician Decision	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Corail n=40 Participants Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem. Total hip replacement with titanium shell and CORAIL stem: Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion).	Tri-Lock n=46 Participants Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock). Total hip replacement with Modular Titanium Femoral Stem: Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert).	Total n=86 Participants Total of all reporting groups
Age, Continuous	58.6 years STANDARD_DEVIATION 10.2 • n=40 Participants	60.4 years STANDARD_DEVIATION 10.1 • n=46 Participants	59.4 years STANDARD_DEVIATION 10.5 • n=86 Participants
Sex: Female, Male Female	23 Participants n=40 Participants	24 Participants n=46 Participants	47 Participants n=86 Participants
Sex: Female, Male Male	17 Participants n=40 Participants	22 Participants n=46 Participants	39 Participants n=86 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	40 participants n=40 Participants	46 participants n=46 Participants	86 participants n=86 Participants
American Society of Anesthesiologists (ASA) Grade Grade 1	3 Participants n=40 Participants	1 Participants n=46 Participants	4 Participants n=86 Participants
American Society of Anesthesiologists (ASA) Grade Grade 2	31 Participants n=40 Participants	28 Participants n=46 Participants	59 Participants n=86 Participants
American Society of Anesthesiologists (ASA) Grade Grade 3	6 Participants n=40 Participants	17 Participants n=46 Participants	23 Participants n=86 Participants

PRIMARY outcome

Timeframe: 2 Years Post-operative

To prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling for the 2 groups. Bone mineral density was assessed using high-sensitivity dual x-ray absorptiometry region-free analysis (DXA-RFA). Mean number of pixels with change with significant BMD decrease.

Outcome measures

Outcome measures
Measure	Corail n=40 Participants Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem. Total hip replacement with titanium shell and CORAIL stem: Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion).	Tri-Lock n=46 Participants Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock). Total hip replacement with Modular Titanium Femoral Stem: Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert).
Change in Bone Mineral Density	1072 number of pixels with change Standard Deviation 50	1295 number of pixels with change Standard Deviation 73

SECONDARY outcome

Timeframe: 2 Years post-operative

Biochemical markers of bone turnover will be assessed from morning-fasting serum samples and compared from baseline to 2-years post-operative.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years post-operative

Stem and cup migration will be assessed using radiographic images at baseline and 2-years post-operative.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 Years post-operative

The change from baseline to 2-years post-operative on the Modified Harris Hip Score (mHHS). The mHHS assesses a patient's functional outcome and pain. The maximum score is 100 and the lowest is 0. A higher score is indicative of better outcomes and lower pain levels.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 Years post-operative

The change from baseline to 2-years post-operative on the SF-36 score: a quality of-life measure. The score consists of 36 questions separated into 8 concepts. These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100. The health related quality of life is increases as the scores are increased. The average score is 50.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 Years post-operative

The change from baseline to 2-years post-operative on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC score consists of 24 items, separated into 3 subscales. Each question is scored on a scale of 0 to 4, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. The scores of each subscale are summed to give a total score. Higher scores are indicative of worse pain, stiffness and functional limitations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 Years post-operatively

The change from baseline to 2-years post-operative on the UCLA Activity score. The UCLA activity scale is a 10 point scale evaluating a patients activity level. The possible score range is from 0-10. A low value is indicative of sedentary or inactivity, whereas a high score is indicative of high levels of activity.

Outcome measures

Outcome data not reported

Adverse Events

Corail

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Tri-Lock

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Corail n=40 participants at risk Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem. Total hip replacement with titanium shell and CORAIL stem: Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion).	Tri-Lock n=46 participants at risk Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock). Total hip replacement with Modular Titanium Femoral Stem: Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert).
Infections and infestations Superficial wound infection	2.5% 1/40 • Number of events 1 • Adverse event data was collected at each standard of care clinical visit (10-14 days post-op, 3-, 6-, 12- and 24-months post-operative).	0.00% 0/46 • Adverse event data was collected at each standard of care clinical visit (10-14 days post-op, 3-, 6-, 12- and 24-months post-operative).
Musculoskeletal and connective tissue disorders Aseptic Loosening	0.00% 0/40 • Adverse event data was collected at each standard of care clinical visit (10-14 days post-op, 3-, 6-, 12- and 24-months post-operative).	2.2% 1/46 • Number of events 1 • Adverse event data was collected at each standard of care clinical visit (10-14 days post-op, 3-, 6-, 12- and 24-months post-operative).

Other adverse events

Other adverse events
Measure	Corail n=40 participants at risk Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem. Total hip replacement with titanium shell and CORAIL stem: Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion).	Tri-Lock n=46 participants at risk Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock). Total hip replacement with Modular Titanium Femoral Stem: Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert).
Musculoskeletal and connective tissue disorders Thigh pain	2.5% 1/40 • Number of events 1 • Adverse event data was collected at each standard of care clinical visit (10-14 days post-op, 3-, 6-, 12- and 24-months post-operative).	10.9% 5/46 • Number of events 5 • Adverse event data was collected at each standard of care clinical visit (10-14 days post-op, 3-, 6-, 12- and 24-months post-operative).
Metabolism and nutrition disorders Intra-operative Calcar Fracture	7.5% 3/40 • Number of events 3 • Adverse event data was collected at each standard of care clinical visit (10-14 days post-op, 3-, 6-, 12- and 24-months post-operative).	2.2% 1/46 • Number of events 1 • Adverse event data was collected at each standard of care clinical visit (10-14 days post-op, 3-, 6-, 12- and 24-months post-operative).
Musculoskeletal and connective tissue disorders Femoral nerve palsy	0.00% 0/40 • Adverse event data was collected at each standard of care clinical visit (10-14 days post-op, 3-, 6-, 12- and 24-months post-operative).	2.2% 1/46 • Number of events 1 • Adverse event data was collected at each standard of care clinical visit (10-14 days post-op, 3-, 6-, 12- and 24-months post-operative).

Additional Information

Dr Paul Beaule

The Ottawa Hospital Research Institute

Phone: 613-737-8899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place