CompletedNCT01183260Updated Nov 7, 2017Results posted

Evaluation of the Trabecular Metal™ Revision Hip Cup Using Bone Mineral Density (DEXA)

An interventional study of Trabecular Metal Revision Cup and Trabecular Metal Modular Cup in Revision, Joint, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-11-07.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 25
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study 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.

Read the detailed description

none provided.

Conditions studied

Revision, Joint

Keywords

revision total hip arthroplasty
bone mineral density
trabecular metal
DEXA

In context

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts 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

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).

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Outcomes assessor)
Enrollment: 25 participants (actual)

Study arms

Experimental
Trabecular Metal Revision Cup
Patients randomized to this arm will receive a trabecular metal revision component which does not have a titanium inner surface and requires a cemented highly crosslinked polyethylene liner.
Device: Trabecular Metal Revision Cup
Active comparator
Trabecular Metal Modular Cup
Patients randomized to this arm will receive a trabecular metal modular component which has a titanium inner surface and requires a non-cemented highly crosslinked polyethylene liner.
Device: Trabecular Metal Modular Cup

Interventions

DeviceTrabecular Metal Revision Cup
Revision of the acetabular cup
DeviceTrabecular Metal Modular Cup
Revision of the acetabular cup

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Results

Posted Nov 7, 2017

Limitations and caveats

A large amount of variability was present in the data leading to reduced statistical power during hypothesis testing

Participant flow

Recruitment period: 2010 - 2014

Participant flow — Overall Study
Milestone	Zimmer Trabecular Metal Acetabular Cup	Zimmer Modular Cup
Started	14	11
Completed	10	9
Not completed	4	2
Withdrew: Intraop screen failure	2	0
Withdrew: Withdrawal by subject	1	1
Withdrew: Revised within 30 days	0	1
Withdrew: Death	1	0

Outcome measures

PrimaryPeriprosthetic 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
Reported as:: Mean · g/cm^2

Periprosthetic Bone Mineral Density (BMD) of Hip
g/cm^2	Zimmer Trabecular Metal Acetabular Cup	Zimmer Modular Cup
3 Month - Region 1	1.63 ± 0.42	1.64 ± 0.38
3 Month - Region 2	1.85 ± 0.34	1.64 ± 0.31
3 Month - Region 3	1.27 ± 0.33	0.92 ± 0.31
3 Month - Lumbar Spine (L1-L4)	1.29 ± 0.15	1.21 ± 0.18
6 Month - Region 1	1.61 ± 0.18	1.82 ± 0.28
6 Month - Region 2	1.75 ± 0.31	1.76 ± 0.33
6 Month - Region 3	1.22 ± 0.30	0.94 ± 0.30
6 Month - Lumbar Spine (L1-L4)	1.29 ± 0.17	1.22 ± 0.16
1 Year - Region 1	1.64 ± 0.17	1.84 ± 0.34
1 Year - Region 2	1.82 ± 0.28	1.72 ± 0.41
1 Year - Region 3	1.23 ± 0.14	1.22 ± 0.16
1 Year - Lumbar Spine (L1-L4)	1.26 ± 0.14	1.22 ± 0.16
2 Year - Region 1	1.75 ± 0.23	1.93 ± 0.45
2 Year - Region 2	1.76 ± 0.24	1.83 ± 0.71
2 Year - Region 3	1.19 ± 0.24	1.00 ± 0.36
2 Year - Lumbar Spine (L1-L4)	1.26 ± 0.14	1.15 ± 0.14

SecondaryFunctional 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
Reported as:: Mean · units on a scale

Functional and General Health Outcome Assessments
units on a scale	Zimmer Trabecular Metal Acetabular Cup	Zimmer Modular Cup
Preop SF12 PCS	32.25 ± 5.86	38.57 ± 12.07
Preop SF12 MCS	55.29 ± 8.07	47.62 ± 10.39
3 Month SF12 PCS	32.25 ± 8.38	38.57 ± 11.63
3 Month SF12 MCS	51.78 ± 8.10	51.09 ± 9.45
6 Month SF12 PCS	32.14 ± 7.22	40.12 ± 13.00
6 Month SF12 MCS	50.51 ± 11.53	52.83 ± 7.70
1 Year SF12 PCS	31.04 ± 12.54	42.84 ± 16.14
1 Year SF12 MCS	55.58 ± 10.18	54.04 ± 8.64
2 Year SF12 PCS	36.10 ± 11.39	47.05 ± 13.52
2 Year SF12 MCS	53.46 ± 7.93	48.66 ± 11.24
Preop HOOS Pain	50.25 ± 20.19	36.67 ± 25.19
Preop HOOS Symptoms	46.50 ± 18.72	38.33 ± 27.95
Preop HOOS ADL	39.48 ± 8.63	32.11 ± 31.24
Preop HOOS Sports/Rec	8.75 ± 12.96	15.28 ± 21.40
Preop HOOS QOL	28.89 ± 31.95	27.16 ± 25.53
3 Month HOOS Pain	61.50 ± 16.72	76.39 ± 17.37
3 Month HOOS Symptoms	55.50 ± 19.50	66.67 ± 18.03
3 Month HOOS ADL	52.45 ± 14.23	66.81 ± 17.09
3 Month HOOS Sports/Rec	21.88 ± 16.39	29.17 ± 15.80
3 Month HOOS QOL	28.89 ± 16.73	49.38 ± 30.99
6 Month HOOS Pain	61.94 ± 19.07	81.94 ± 14.02
6 Month HOOS Symptoms	58.33 ± 17.68	76.67 ± 19.04
6 Month HOOS ADL	55.56 ± 15.71	76.79 ± 17.15
6 Month HOOS Sports/Rec	26.39 ± 18.00	46.13 ± 29.98
6 Month HOOS QOL	37.04 ± 23.57	49.38 ± 37.31
1 Year HOOS Pain	61.88 ± 27.57	81.67 ± 12.18
1 Year HOOS Symptoms	63.75 ± 30.68	75.83 ± 18.03
1 Year HOOS ADL	56.88 ± 26.80	76.88 ± 17.77
1 Year HOOS Sports/Rec	20.49 ± 20.68	51.49 ± 19.79
1 Year HOOS QOL	38.89 ± 31.98	56.79 ± 37.45
2 Year HOOS Pain	69.64 ± 26.71	82.92 ± 24.41
2 Year HOOS Symptoms	65.54 ± 23.98	70.00 ± 29.83
2 Year HOOS ADL	66.19 ± 26.93	77.38 ± 18.65
2 Year HOOS Sports/Rec	39.58 ± 25.43	65.83 ± 20.92
2 Year HOOS QOL	60.32 ± 29.99	62.96 ± 24.00

Adverse events

Collected over 2 Years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Zimmer Trabecular Metal Acetabular Cup	1/14 (7.1%)	0/14 (0%)	0/14 (0%)
Zimmer Modular Cup	0/11 (0%)	1/11 (9.1%)	0/11 (0%)

Most frequent serious events

Most frequent serious events
Event	Zimmer Trabecular Metal Acetabular Cup	Zimmer Modular Cup
Revision surgery due to multiple dislocationsSurgical and medical procedures	0/14	1/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Zimmer Trabecular Metal Acetabular Cup	Zimmer Modular Cup	Total
Mean	58.60 ± 11.40	61.11 ± 9.74	59.79 ± 10.15

Sex: Female, Male
Sex: Female, Male(Participants)	Zimmer Trabecular Metal Acetabular Cup	Zimmer Modular Cup	Total
Female	4	5	9
Male	6	4	10

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Zimmer Trabecular Metal Acetabular Cup	Zimmer Modular Cup	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(Participants)	Zimmer Trabecular Metal Acetabular Cup	Zimmer Modular Cup	Total
United States	10	9	19

Operative Side: Left, Right
Operative Side: Left, Right(Participants)	Zimmer Trabecular Metal Acetabular Cup	Zimmer Modular Cup	Total
Left	5	5	10
Right	5	4	9

BMI (kg/m^2), Continuous
BMI (kg/m^2), Continuous(kg/m^2)	Zimmer Trabecular Metal Acetabular Cup	Zimmer Modular Cup	Total
Mean	30.14 ± 6.07	30.49 ± 7.56	30.31 ± 6.44

Study locations

1 site

The Cleveland Clinic
Cleveland, Ohio 44195, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01183260
Lead sponsor: The Cleveland Clinic
Collaborators: Zimmer Biomet
Responsible party: Wael Barsoum (MD, Chairman of Surgical Operations, The Cleveland Clinic) — Principal investigator
First posted: Aug 17, 2010
Start date: Aug 2010
Primary completion: Aug 2016
Completion: Jan 2017
Results posted: Nov 7, 2017
Last update: Nov 7, 2017

Study contacts

Wael K Barsoum, MD

principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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