Trial Outcomes & Findings for Ceramic on Metal Total Hip Replacement System Multi-Center,Investigational Device Exemption Clinical Trial (NCT NCT00820443)

NCT ID: NCT00820443

Last Updated: 2015-09-30

Results Overview

The patient success definition is measured at the 24 month interval by the following: * Harris Hip Score (HHS) of \> 80 • \< 2mm radiolucency (width) in any Gruen (stem) or DeLee/Charnley (cup) zone and no more than mild pain. * No revision or removal of any part of the device for aseptic reasons prior to or on day 730 following the index surgical procedure. A patient must meet all three criteria in the definition to be considered a success. A patient who does not meet all three criteria will be deemed a failure. The Harris hip score, is used to measure the outcome of total hip arthroplasty. Eight sections on the HIP are rated by the patient: pain, distance walked, activities, public transportation, support, limp, stairs and sitting. Total scores are out of 100 and grouped as follows: 90 - 100 Excellent,80 - 90 Good,70 - 79 Fair,60 - 69 Poor.\< 60 Failed.Any score above 60 is acceptable, although the higher the score, the better the patient's overall adjustment after the surgery

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

253 participants

Primary outcome timeframe

24 Month

Results posted on

2015-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	Ceramic on Metal Prosthesis Ceramic on metal prosthesis Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component
Pre-Op STARTED	253
Pre-Op COMPLETED	253
Pre-Op NOT COMPLETED	0
Op STARTED	253
Op COMPLETED	253
Op NOT COMPLETED	0
Immediately STARTED	253
Immediately COMPLETED	248
Immediately NOT COMPLETED	5
3 Month STARTED	253
3 Month COMPLETED	244
3 Month NOT COMPLETED	9
6 Month STARTED	253
6 Month COMPLETED	233
6 Month NOT COMPLETED	20
12 Month STARTED	250
12 Month COMPLETED	226
12 Month NOT COMPLETED	24
24 Month STARTED	245
24 Month COMPLETED	202
24 Month NOT COMPLETED	43

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ceramic on Metal Total Hip Replacement System Multi-Center,Investigational Device Exemption Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ceramic on Metal Prosthesis n=253 Participants Ceramic on metal prosthesis Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component
Age, Continuous Female	60.8 years STANDARD_DEVIATION 12.9 • n=5 Participants
Age, Continuous Male	60.3 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants
Sex: Female, Male Male	125 Participants n=5 Participants
BMI Female	28.2 kg/m^(2) STANDARD_DEVIATION 5.2 • n=5 Participants
BMI Male	29.1 kg/m^(2) STANDARD_DEVIATION 4.6 • n=5 Participants
Height Female	64.2 Inches STANDARD_DEVIATION 2.4 • n=5 Participants
Height Male	70.4 Inches STANDARD_DEVIATION 3.0 • n=5 Participants
Weight Female	164.7 lbs STANDARD_DEVIATION 31.1 • n=5 Participants
Weight Male	205.4 lbs STANDARD_DEVIATION 37.3 • n=5 Participants
Diagnosis Osteo/degenerative arthritis	216 participants n=5 Participants
Diagnosis Post-traumatic Arthritis	4 participants n=5 Participants
Diagnosis Avascular necrosis	25 participants n=5 Participants
Diagnosis Rheumatoid Arthritis	3 participants n=5 Participants
Diagnosis Congenital Hip Dysplasia	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Month

Population: Patients with Harris Hip Score (HHS) of \> 80 Because there isn't complete radiographic data,the composite primary outcome is not analyzed at 24 month as in protocol. Only the number of patients who has HHS score greater that 80 is entered.Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 197.

Outcome measures

Outcome measures
Measure	Ceramic on Metal Prosthesis n=197 Participants Ceramic on metal prosthesis Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component
Primary Endpoint/Measures: Success at 24 Months	163 participants

SECONDARY outcome

Timeframe: 24 months

Population: Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 177 participants were evaluated at 24 months.

UCLA: University of California LosAngeles Activity Score UCLA score is a validated scoring system for hip replacement outcome, The single item UCLA scale asks patients to rate their activity level from 1 to 10, with 1 defined as "no physical activity" and 10 defined as "regular participation in impact sports". The score is the higher the better.

Outcome measures

Outcome measures
Measure	Ceramic on Metal Prosthesis n=177 Participants Ceramic on metal prosthesis Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component
The Secondary Measures of the UCLA Functional Assessments	6.8 units on a scale (10 points) Standard Deviation 1.7

SECONDARY outcome

Timeframe: 24 months

Population: Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 175 participants were evaluated at 24 months.

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations (range is 0-96).

Outcome measures

Outcome measures
Measure	Ceramic on Metal Prosthesis n=175 Participants Ceramic on metal prosthesis Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component
WOMAC Raw Total Score	5.3 units on a scale Standard Deviation 11.1

SECONDARY outcome

Timeframe: 24 months

Population: Only Unilateral participants were collected the Metal Ion data, and due to missing values/assessments/data, not all of the unilateral participants had Metal Ion data at 24 months, only 44 of them were evaluated.

Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant.

Outcome measures

Outcome measures
Measure	Ceramic on Metal Prosthesis n=44 Participants Ceramic on metal prosthesis Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component
Metal Ion Analysis (Unilateral Only):Serum Cobalt	1.06 ug/L Standard Deviation 0.12

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Outcome measures
Measure	Ceramic on Metal Prosthesis n=44 Participants Ceramic on metal prosthesis Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component
Metal Ion Analysis; Unilateral Only; Serum Chromium	0.79 ug/L Standard Deviation 0.12

Adverse Events

Ceramic on Metal Prosthesis

Serious events: 22 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ceramic on Metal Prosthesis n=253 participants at risk Ceramic on metal prosthesis Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component
Blood and lymphatic system disorders Anemia	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Cardiac disorders Atrial Fibrillation	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Vascular disorders Osteonecrosis	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumor of the stomach	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Infections and infestations Cellulitis	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Infections and infestations Abscess Neck	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Vascular disorders Intermittent Claudication	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Surgical and medical procedures Intervertebral disc operation	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Vascular disorders Myocardial infarction	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Reproductive system and breast disorders Ovarian Cancer	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Gastrointestinal disorders Pancreatic carcinoma	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Infections and infestations Pneumonia	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Gastrointestinal disorders Retroperitoneal Haemorrhage	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Surgical and medical procedures Hip arthroplasty	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Nervous system disorders Seizure	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Cardiac disorders Cardiac arrest	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Skin and subcutaneous tissue disorders Subcutaneous abscess	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Musculoskeletal and connective tissue disorders Bursitis	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Infections and infestations Wound infection	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
General disorders Surgical failure	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
General disorders Chest Pain	0.40% 1/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.

Other adverse events

Other adverse events
Measure	Ceramic on Metal Prosthesis n=253 participants at risk Ceramic on metal prosthesis Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component
Blood and lymphatic system disorders Anemia	10.7% 27/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Musculoskeletal and connective tissue disorders Pain in Hip	8.7% 22/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Musculoskeletal and connective tissue disorders Trochanteric bursitis	8.3% 21/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.
Musculoskeletal and connective tissue disorders Knee Pain	5.9% 15/253 • The period includes all the time with a date of surgery on or before the date of database closure. The AE for all enrolled procedures with a date of surgery on or before the date of database closure are included. n/N, n=number of procedure with a specific complication, N is the total number of procedure implanted and evaluated (N=253). Both AE and SAE are separated and re-coded (MedDRA18.0). For other AE, only \>=5% frequency are reported.

Additional Information

Matt C. Paul, Project Manager

MicroPort Orthepedics

Phone: (901) 867-4350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60