Revision, Joint
Conditions
Keywords
revision total hip arthroplasty, bone mineral density, trabecular metal, DEXA
Brief summary
In 1997, the FDA approved the use of Trabecular Metal™ (Zimmer, Trabecular Metal Technology, Inc., Parsippany, NJ) for acetabular cups, a porous tantalum structural biomaterial that was developed to address the limitations of other implant materials, with the potential to improve implant fixation. Porous tantalum (80% porosity) offers potentially greater ingrowth and bone graft incorporation, believed to be restricted by the low porosity of other commonly used implants (30%). Additionally, the low modulus of elasticity property (3 MPa) of porous tantalum provides more normal physiological loading conditions which theoretically reduce stress shielding and resultant bone loss surrounding the implant. These properties are much desired advantages for implants used in cementless THA. Various porous tantalum implants have shown favorable clinical results. Unger et al. reported excellent bone graft incorporation of the acetabular component based on serial radiograph data at a minimum 1-year follow-up. Dual-energy X-ray absorptiometry (DEXA) is a well-established method for detecting periprosthetic bone mass changes around the femoral and acetabular THA components. The primary objective of this study is to quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Additionally, this study will analyze and compare clinical outcomes of these patients, based on SF-12v2 and HOOS.
Detailed description
none provided.
Interventions
DEVICETrabecular Metal Revision Cup
Revision of the acetabular cup
DEVICETrabecular Metal Modular Cup
Revision of the acetabular cup
Sponsors
Zimmer Biomet
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 - 85 years * Sex: Both male and female will be included. The male-to-female ratio will depend upon the patient population. * Stable Health: At the time of surgery based on physical examination and medical history. * Patient is a revision total hip recipient, which requires a metal-backed hemispherical cup. * Patient or patient's legal representative has signed the Informed Consent form. The patient is capable of making informed decisions regarding his/her healthcare.
Exclusion criteria
* Patients undergoing bilateral surgery or had prior hip arthroplasty on contralateral side less than 6 months from date of surgery. * Patients who do not plan to return to a Cleveland Clinic surgeon for follow-up visits (i.e. out of state/country patients who may choose to follow-up with a different surgeon). * Patients with history of radiation therapy. * Patients with known diagnosis of Brooker grade 3 or 4 HO (heterotopic ossification) in the hip joint region. * Patients with known diagnosis of renal disease. * Patients with known diagnosis of osteoporosis. * Patients with history of steroid use in the hip joint region. * Patients that have had a previous lumbar fusion. * Patients whose surgical reconstruction required a pelvic cage or plate. * Patient was a poor compliance risk - treated for ethanol or drug abuse, physical or mental handicap, etc. * Any female of childbearing potential who is pregnant or is planning on becoming pregnant during the study period (\ 2 years postoperative).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periprosthetic Bone Mineral Density (BMD) of Hip | 2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperative | Quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Region 1 forms the superior-lateral region, Region 2 forms the superior-medial region, and Region 3 forms the inferior-medial region around the acetabular component. For each region, the mean change in BMD was calculated using the following equation described by Wilkinson et al (J Bone Joint Surg Br., 2001): mean percent change in BMD = (BMD1-BMD2) x 2 x 100 / (BMD1 + BMD2). These regions were patient specific and remained the same each time the patient was scanned. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional and General Health Outcome Assessments | 2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperative | Analyze and compare functional and general health outcomes of these patients, based on Hip disability and Osteoarthritis Outcomes Score (HOOS) and 12-item Short Form Health Survey (SF-12v2). All subscale scores are calculated independently and range from 0 to 100, where 100 indicates no problems: * SF-12 Physical Component Summary Subscale (SF12 PCS) assesses physical function, bodily pain, and general health. * SF-12 Mental Component Summary Subscale (SF12 MCS) assesses emotional and mental health. * HOOS Pain assesses pain in the hip * HOOS Symptoms assesses symptoms such as stiffness in the hip * HOOS activities of daily living (HOOS ADL) assesses physical function while performing common daily activities (walking, sitting, standing, etc.) * HOOS sport and recreation (HOOS Sports/Rec) assesses physical function while performing higher-level activities (running, squatting, etc.) * HOOS hip-related quality of life (HOOS QOL) assesses how much the hip impacts life |
Countries
United States
Participant flow
Recruitment details
Recruitment period: 2010 - 2014
Participants by arm
| Arm | Count |
|---|---|
| Zimmer Trabecular Metal Acetabular Cup Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup | 10 |
| Zimmer Modular Cup Zimmer Modular Cup: Revision of the acetabular cup | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Intraop screen failure | 2 | 0 |
| Overall Study | Revised within 30 days | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Zimmer Trabecular Metal Acetabular Cup | Zimmer Modular Cup | Total |
|---|---|---|---|
| Age, Continuous | 58.60 years STANDARD_DEVIATION 11.4 | 61.11 years STANDARD_DEVIATION 9.74 | 59.79 years STANDARD_DEVIATION 10.15 |
| BMI (kg/m^2), Continuous | 30.14 kg/m^2 STANDARD_DEVIATION 6.07 | 30.49 kg/m^2 STANDARD_DEVIATION 7.56 | 30.31 kg/m^2 STANDARD_DEVIATION 6.44 |
| Operative Side: Left, Right Left | 5 Participants | 5 Participants | 10 Participants |
| Operative Side: Left, Right Right | 5 Participants | 4 Participants | 9 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 14 | 0 / 11 |
| other Total, other adverse events | 0 / 14 | 0 / 11 |
| serious Total, serious adverse events | 0 / 14 | 1 / 11 |
Outcome results
Primary
Periprosthetic Bone Mineral Density (BMD) of Hip
Quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Region 1 forms the superior-lateral region, Region 2 forms the superior-medial region, and Region 3 forms the inferior-medial region around the acetabular component. For each region, the mean change in BMD was calculated using the following equation described by Wilkinson et al (J Bone Joint Surg Br., 2001): mean percent change in BMD = (BMD1-BMD2) x 2 x 100 / (BMD1 + BMD2). These regions were patient specific and remained the same each time the patient was scanned.
Time frame: 2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperative
Population: By Year 2, there were 3 patients lost to follow-up in the Revision Cup group and 3 patients lost to follow-up in the Modular Cup group:~We were unable to contact 1 patient from each group in order to schedule follow-up The remaining patients were withdrawn because they were feeling fine and declined to return for follow-up at that time
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 3 Month - Region 1 | 1.63 g/cm^2 | Standard Deviation 0.42 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 3 Month - Region 2 | 1.85 g/cm^2 | Standard Deviation 0.34 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 3 Month - Region 3 | 1.27 g/cm^2 | Standard Deviation 0.33 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 3 Month - Lumbar Spine (L1-L4) | 1.29 g/cm^2 | Standard Deviation 0.15 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 6 Month - Region 1 | 1.61 g/cm^2 | Standard Deviation 0.18 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 6 Month - Region 2 | 1.75 g/cm^2 | Standard Deviation 0.31 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 6 Month - Region 3 | 1.22 g/cm^2 | Standard Deviation 0.3 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 6 Month - Lumbar Spine (L1-L4) | 1.29 g/cm^2 | Standard Deviation 0.17 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 1 Year - Region 1 | 1.64 g/cm^2 | Standard Deviation 0.17 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 1 Year - Region 2 | 1.82 g/cm^2 | Standard Deviation 0.28 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 1 Year - Region 3 | 1.23 g/cm^2 | Standard Deviation 0.14 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 1 Year - Lumbar Spine (L1-L4) | 1.26 g/cm^2 | Standard Deviation 0.14 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 2 Year - Region 1 | 1.75 g/cm^2 | Standard Deviation 0.23 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 2 Year - Region 2 | 1.76 g/cm^2 | Standard Deviation 0.24 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 2 Year - Region 3 | 1.19 g/cm^2 | Standard Deviation 0.24 |
| Zimmer Trabecular Metal Acetabular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 2 Year - Lumbar Spine (L1-L4) | 1.26 g/cm^2 | Standard Deviation 0.14 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 2 Year - Lumbar Spine (L1-L4) | 1.15 g/cm^2 | Standard Deviation 0.14 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 3 Month - Region 1 | 1.64 g/cm^2 | Standard Deviation 0.38 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 1 Year - Region 1 | 1.84 g/cm^2 | Standard Deviation 0.34 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 3 Month - Region 2 | 1.64 g/cm^2 | Standard Deviation 0.31 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 2 Year - Region 1 | 1.93 g/cm^2 | Standard Deviation 0.45 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 3 Month - Region 3 | 0.92 g/cm^2 | Standard Deviation 0.31 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 1 Year - Region 2 | 1.72 g/cm^2 | Standard Deviation 0.41 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 3 Month - Lumbar Spine (L1-L4) | 1.21 g/cm^2 | Standard Deviation 0.18 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 2 Year - Region 3 | 1.00 g/cm^2 | Standard Deviation 0.36 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 6 Month - Region 1 | 1.82 g/cm^2 | Standard Deviation 0.28 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 1 Year - Region 3 | 1.22 g/cm^2 | Standard Deviation 0.16 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 6 Month - Region 2 | 1.76 g/cm^2 | Standard Deviation 0.33 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 2 Year - Region 2 | 1.83 g/cm^2 | Standard Deviation 0.71 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 6 Month - Region 3 | 0.94 g/cm^2 | Standard Deviation 0.3 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 1 Year - Lumbar Spine (L1-L4) | 1.22 g/cm^2 | Standard Deviation 0.16 |
| Zimmer Modular Cup | Periprosthetic Bone Mineral Density (BMD) of Hip | 6 Month - Lumbar Spine (L1-L4) | 1.22 g/cm^2 | Standard Deviation 0.16 |
Secondary
Functional and General Health Outcome Assessments
Analyze and compare functional and general health outcomes of these patients, based on Hip disability and Osteoarthritis Outcomes Score (HOOS) and 12-item Short Form Health Survey (SF-12v2). All subscale scores are calculated independently and range from 0 to 100, where 100 indicates no problems: * SF-12 Physical Component Summary Subscale (SF12 PCS) assesses physical function, bodily pain, and general health. * SF-12 Mental Component Summary Subscale (SF12 MCS) assesses emotional and mental health. * HOOS Pain assesses pain in the hip * HOOS Symptoms assesses symptoms such as stiffness in the hip * HOOS activities of daily living (HOOS ADL) assesses physical function while performing common daily activities (walking, sitting, standing, etc.) * HOOS sport and recreation (HOOS Sports/Rec) assesses physical function while performing higher-level activities (running, squatting, etc.) * HOOS hip-related quality of life (HOOS QOL) assesses how much the hip impacts life
Time frame: 2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperative
Population: By Year 2, there were 3 patients lost to follow-up in the Revision Cup group and 3 patients lost to follow-up in the Modular Cup group:~We were unable to contact 1 patient from each group in order to schedule follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 2 Year SF12 MCS | 53.46 units on a scale | Standard Deviation 7.93 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 3 Month HOOS Sports/Rec | 21.88 units on a scale | Standard Deviation 16.39 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 6 Month SF12 MCS | 50.51 units on a scale | Standard Deviation 11.53 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 3 Month HOOS QOL | 28.89 units on a scale | Standard Deviation 16.73 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | Preop HOOS Pain | 50.25 units on a scale | Standard Deviation 20.19 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 6 Month HOOS Pain | 61.94 units on a scale | Standard Deviation 19.07 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 3 Month SF12 MCS | 51.78 units on a scale | Standard Deviation 8.1 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 6 Month HOOS Symptoms | 58.33 units on a scale | Standard Deviation 17.68 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | Preop HOOS Symptoms | 46.50 units on a scale | Standard Deviation 18.72 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 6 Month HOOS ADL | 55.56 units on a scale | Standard Deviation 15.71 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 1 Year SF12 PCS | 31.04 units on a scale | Standard Deviation 12.54 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 6 Month HOOS Sports/Rec | 26.39 units on a scale | Standard Deviation 18 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | Preop HOOS ADL | 39.48 units on a scale | Standard Deviation 8.63 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 6 Month HOOS QOL | 37.04 units on a scale | Standard Deviation 23.57 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 3 Month SF12 PCS | 32.25 units on a scale | Standard Deviation 8.38 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 1 Year HOOS Pain | 61.88 units on a scale | Standard Deviation 27.57 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | Preop HOOS Sports/Rec | 8.75 units on a scale | Standard Deviation 12.96 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 1 Year HOOS Symptoms | 63.75 units on a scale | Standard Deviation 30.68 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 1 Year SF12 MCS | 55.58 units on a scale | Standard Deviation 10.18 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 1 Year HOOS ADL | 56.88 units on a scale | Standard Deviation 26.8 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | Preop HOOS QOL | 28.89 units on a scale | Standard Deviation 31.95 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 1 Year HOOS Sports/Rec | 20.49 units on a scale | Standard Deviation 20.68 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 6 Month SF12 PCS | 32.14 units on a scale | Standard Deviation 7.22 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 1 Year HOOS QOL | 38.89 units on a scale | Standard Deviation 31.98 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 3 Month HOOS Pain | 61.50 units on a scale | Standard Deviation 16.72 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 2 Year HOOS Pain | 69.64 units on a scale | Standard Deviation 26.71 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 2 Year SF12 PCS | 36.10 units on a scale | Standard Deviation 11.39 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 2 Year HOOS Symptoms | 65.54 units on a scale | Standard Deviation 23.98 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 3 Month HOOS Symptoms | 55.50 units on a scale | Standard Deviation 19.5 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 2 Year HOOS ADL | 66.19 units on a scale | Standard Deviation 26.93 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | Preop SF12 MCS | 55.29 units on a scale | Standard Deviation 8.07 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 2 Year HOOS Sports/Rec | 39.58 units on a scale | Standard Deviation 25.43 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 3 Month HOOS ADL | 52.45 units on a scale | Standard Deviation 14.23 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | 2 Year HOOS QOL | 60.32 units on a scale | Standard Deviation 29.99 |
| Zimmer Trabecular Metal Acetabular Cup | Functional and General Health Outcome Assessments | Preop SF12 PCS | 32.25 units on a scale | Standard Deviation 5.86 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 2 Year HOOS QOL | 62.96 units on a scale | Standard Deviation 24 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | Preop SF12 PCS | 38.57 units on a scale | Standard Deviation 12.07 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | Preop SF12 MCS | 47.62 units on a scale | Standard Deviation 10.39 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 3 Month SF12 PCS | 38.57 units on a scale | Standard Deviation 11.63 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 3 Month SF12 MCS | 51.09 units on a scale | Standard Deviation 9.45 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 6 Month SF12 PCS | 40.12 units on a scale | Standard Deviation 13 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 6 Month SF12 MCS | 52.83 units on a scale | Standard Deviation 7.7 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 1 Year SF12 PCS | 42.84 units on a scale | Standard Deviation 16.14 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 1 Year SF12 MCS | 54.04 units on a scale | Standard Deviation 8.64 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 2 Year SF12 PCS | 47.05 units on a scale | Standard Deviation 13.52 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 2 Year SF12 MCS | 48.66 units on a scale | Standard Deviation 11.24 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | Preop HOOS Pain | 36.67 units on a scale | Standard Deviation 25.19 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | Preop HOOS Symptoms | 38.33 units on a scale | Standard Deviation 27.95 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | Preop HOOS ADL | 32.11 units on a scale | Standard Deviation 31.24 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | Preop HOOS Sports/Rec | 15.28 units on a scale | Standard Deviation 21.4 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | Preop HOOS QOL | 27.16 units on a scale | Standard Deviation 25.53 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 3 Month HOOS Pain | 76.39 units on a scale | Standard Deviation 17.37 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 3 Month HOOS Symptoms | 66.67 units on a scale | Standard Deviation 18.03 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 3 Month HOOS ADL | 66.81 units on a scale | Standard Deviation 17.09 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 3 Month HOOS Sports/Rec | 29.17 units on a scale | Standard Deviation 15.8 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 3 Month HOOS QOL | 49.38 units on a scale | Standard Deviation 30.99 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 6 Month HOOS Pain | 81.94 units on a scale | Standard Deviation 14.02 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 6 Month HOOS Symptoms | 76.67 units on a scale | Standard Deviation 19.04 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 6 Month HOOS ADL | 76.79 units on a scale | Standard Deviation 17.15 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 6 Month HOOS Sports/Rec | 46.13 units on a scale | Standard Deviation 29.98 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 6 Month HOOS QOL | 49.38 units on a scale | Standard Deviation 37.31 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 1 Year HOOS Pain | 81.67 units on a scale | Standard Deviation 12.18 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 1 Year HOOS Symptoms | 75.83 units on a scale | Standard Deviation 18.03 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 1 Year HOOS ADL | 76.88 units on a scale | Standard Deviation 17.77 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 1 Year HOOS Sports/Rec | 51.49 units on a scale | Standard Deviation 19.79 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 1 Year HOOS QOL | 56.79 units on a scale | Standard Deviation 37.45 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 2 Year HOOS Pain | 82.92 units on a scale | Standard Deviation 24.41 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 2 Year HOOS Symptoms | 70.00 units on a scale | Standard Deviation 29.83 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 2 Year HOOS ADL | 77.38 units on a scale | Standard Deviation 18.65 |
| Zimmer Modular Cup | Functional and General Health Outcome Assessments | 2 Year HOOS Sports/Rec | 65.83 units on a scale | Standard Deviation 20.92 |