A Clinical Trial of a Metal on Poly Component Versus CORAIL Stem: A Bone Mineral Density Study

• Sponsor: Ottawa Hospital Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01558752
• Collaborator: Johnson & Johnson (Industry)
• Enrollment: 88
• Location: 1
• Arms: 2
• Actual Duration (Months): 127.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The main goal is to prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem compared to a modular titanium femoral stem (Tri-lock). Patients will be randomized to one of the two treatment groups prior to surgery. Each patient will be evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month visits following surgery. Patients will be asked to have bilateral DEXA bone mineral density tests (10-14 days post-surgery, and 6, 12 and 24 months post-operatively). Urine and serum samples (measures of bone turnover) will be collected at 3, 6 and 12 months post-operatively after an overnight fast. Patient reported questionnaires will be completed preoperatively and at the 3, 6, 12, and 24 month visits.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty	Device: Total hip replacement with titanium shell and CORAIL stem; Device: Total hip replacement with Modular Titanium Femoral Stem	N/A

Detailed Description

The main goal is to prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem compared to a modular titanium femoral stem (Tri-lock). The investigators expect the CORAIL femoral stem group to show significantly less bone loss on the femoral side as compared to the Tri-lock group. The primary outcome is percent change in bone mineral density (BMD) (g/cm2) from baseline (10-14 days post-op) to the two year post-operative interval, as measured radiographically in zones 1 and 7.

Patients will be randomized to one of the two treatment groups prior to surgery. Each patient will be evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month visits following surgery.

Bilateral DXA bone mineral density tests will be performed at 10-14 days following surgery (baseline assessment) and at 6, 12, and 24 months post-operatively.

Urine and serum samples (measures of bone turnover) will be collected at 3, 6 and 12 months post-operatively after an overnight fast.

The Harris Hip Score will be completed at each post-operative visit except the immediate (10-14 days), when risk of dislocation precludes a determination of range of motion. At the 3, 6, 12 and 24 month post-operative visits, the patient will complete the SF-36 Item Health Survey, WOMAC and UCLA activity scale.

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial of a Modular Cementless Acetabular Metal on Poly Component Versus a Monoblock Cementless Titanium Shell With Ceramic on Ceramic Bearing and CORAIL Stem: A Bone Mineral Density Study
• Actual Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Jul 31, 2019
• Actual Study Completion Date: Nov 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Titanium Shell with CORAIL stem Patients in Group 1 will receive a total hip replacement with titanium shell and CORAIL stem.	Device: 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).
Active Comparator: Modular Titanium Femoral Stem (Tri-Lock) Patients in Group 2 will receive a total hip replacement with Modular Titanium Femoral Stem (Tri-lock).	Device: 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).

Outcome Measures

Primary Outcome Measures

1. Change in Bone Mineral Density [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.

Secondary Outcome Measures

1. Comparison of Bone Turnover Markers Between Groups [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.

2. Implant Migration [2 years post-operative]

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

3. Change in Modified Harris Hip Score [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.

4. Change in SF-36 Score [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.

5. Change in WOMAC Questionnaire [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.

6. Change in UCLA Activity Scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who are undergoing primary hip surgery for osteo/degenerative arthritis (does not include traumatic arthritis, congenital hip dysplasia, or avascular necrosis).

• Patients who are skeletally mature, as determined by Risser sign or at least 18 years of age

• Patients under 75 years of age

• Patients for whom there is a reasonable expectation that they will be available for each examination scheduled over a two year post-operative follow-up period.

Exclusion Criteria:

• Patients with previous fusions, acute femoral neck fractures and above knee amputations.

• Patients with evidence of active local infection

• Patients with neurologic or musculoskeletal disease that may adversely affect gait or weight-bearing.

• Patients who have previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device, or any prior hip surgery or retained internal fixation.

• Patients who are anticipated to require contralateral hip surgery in the next year

• Patients with known disorders of bone metabolism, systemic inflammatory disorders, and use of drug medications, including oral steroids, HRT, Tamoxifen, calcium, or vitamin D in the past year, and any past bisphosphonate therapy.

• Patients with a Body Mass Index (BMI) > 35

• Patients with neuropathic joints

• Patients with severe documented psychiatric disease

• Patients requiring structural bone grafts

• Patients with an ipsilateral girdlestone

• Patients with sickle cell disease

• Patients with major acetabular bone stock deficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ottawa Hospital - General Campus	Ottawa	Ontario	Canada	K1H 8L6

Sponsors and Collaborators

• Ottawa Hospital Research Institute
• Johnson & Johnson

Investigators

• Principal Investigator: Paul E Beaulé, MD, FRCSC, Ottawa Hospital Research Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 7, 2013

More Information

Publications

None provided.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT01558752
• Other Study ID Numbers: 2010913-01H
• First Posted: Mar 20, 2012
• Last Update Posted: Dec 19, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ottawa Hospital Research Institute: Total Hip Replacement; Bone Mineral Density; Stem; Dual-energy x-ray absorptiometry; DXA-RFA; Corail; Tri-Lock

Study Results

Participant Flow

Arm/Group Title	Corail	Tri-Lock
Arm/Group Description	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).	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).
Period Title: Overall Study
STARTED	42	46
COMPLETED	40	46
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Corail	Tri-Lock	Total
Arm/Group Description	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).	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 of all reporting groups
Overall Participants	40	46	86
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.6 (10.2)	60.4 (10.1)	59.4 (10.5)
Sex: Female, Male (Count of Participants)
Female	23 57.5%	24 52.2%	47 54.7%
Male	17 42.5%	22 47.8%	39 45.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Canada	40 100%	46 100%	86 100%
American Society of Anesthesiologists (ASA) Grade (Count of Participants)
Grade 1	3 7.5%	1 2.2%	4 4.7%
Grade 2	31 77.5%	28 60.9%	59 68.6%
Grade 3	6 15%	17 37%	23 26.7%

Outcome Measures

1. Primary Outcome

Title	Change in Bone Mineral Density
Description	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.
Time Frame	2 Years Post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Corail	Tri-Lock
Arm/Group Description	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).	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).
Measure Participants	40	46
Mean (Standard Deviation) [number of pixels with change]	1072 (50)	1295 (73)

2. Secondary Outcome

Title	Comparison of Bone Turnover Markers Between Groups
Description	Biochemical markers of bone turnover will be assessed from morning-fasting serum samples and compared from baseline to 2-years post-operative.
Time Frame	2 Years post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Implant Migration
Description	Stem and cup migration will be assessed using radiographic images at baseline and 2-years post-operative.
Time Frame	2 years post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Change in Modified Harris Hip Score
Description	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.
Time Frame	2 Years post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Change in SF-36 Score
Description	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.
Time Frame	2 Years post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Change in WOMAC Questionnaire
Description	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.
Time Frame	2 Years post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Change in UCLA Activity Scale
Description	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.
Time Frame	2 Years post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	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).
Arm/Group Title	Corail		Tri-Lock
Arm/Group Description	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).		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).
All Cause Mortality
	Corail		Tri-Lock
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/46 (0%)
Serious Adverse Events
	Corail		Tri-Lock
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/40 (2.5%)		1/46 (2.2%)
Infections and infestations
Superficial wound infection	1/40 (2.5%)	1	0/46 (0%)	0
Musculoskeletal and connective tissue disorders
Aseptic Loosening	0/40 (0%)	0	1/46 (2.2%)	1
Other (Not Including Serious) Adverse Events
	Corail		Tri-Lock
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/40 (10%)		7/46 (15.2%)
Metabolism and nutrition disorders
Intra-operative Calcar Fracture	3/40 (7.5%)	3	1/46 (2.2%)	1
Musculoskeletal and connective tissue disorders
Thigh pain	1/40 (2.5%)	1	5/46 (10.9%)	5
Femoral nerve palsy	0/40 (0%)	0	1/46 (2.2%)	1

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.