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| ID | Type | Description | Link |
|---|---|---|---|
| Study #09013 | Other Grant/Funding Number | DePuy Orthopaedics, Inc. |
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| Name | Class |
|---|---|
| DePuy Orthopaedics | INDUSTRY |
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This retrospective study will review the Anderson Orthopaedic Institute's initial experience among a consecutive series of 126 patients who had primary total hip arthroplasty using a metal-on-metal articulation consisting of a DePuy Pinnacle cup with an Ultamet liner coupled with a 36-mm cobalt-chrome alloy femoral head. The relationship between metal ion levels, cup orientation, osteolysis, radiographic implant stability and clinical outcome measures including component revision, complications, patient satisfaction and Harris Hip Scores will be evaluated.
Metal-on-metal bearings for total hip arthroplasty are an alternative to traditional polyethylene bearing surfaces and hip simulators studies have shown that metal-on-metal bearings have lower wear than metal-on-polyethylene bearings. In addition, simulator studies indicate that the amount of wear decreases as head size increases allowing the use of larger head diameters than possible with other bearing surfaces. Since dislocation is currently the most common reason for reoperation in the United States, representing 22.5% of hip revisions, the combination of low wear and larger head sizes to reduce dislocation hold the promise of improving outcome among total hip arthroplasty patients. While there are potential advantages to metal-on-metal bearings, a few concerns have been noted in the literature. Although the total volume of wear is low with these bearings, the articulation generates metal debris that may be related to patient and surgical factors such as implant positioning. Despite a reduced wear volume, there is also the possibility that an increased bioreactivity associated with metal debris might induce an osteolytic response or local tissue hypersensitivity reaction.
This study will retrospectively review the outcome of a consecutive series of 126 patients who had 131 primary THAs performed between April 2001 and November 2002 at the Anderson Clinic with a Pinnacle acetabular cup, an Ultamet insert and a 36-mm cobalt-chrome alloy femoral head. These total hip arthroplasties represent the Anderson Orthopaedic Institute's in initial experience with this implant. The relationship between metal ion levels, cup orientation, osteolysis, radiographic implant stability and clinical outcome measures including component revision, complications, patient satisfaction and Harris Hip Scores will be evaluated. The outcome data from our analysis will also be compared with the data from other published series with metal-on-metal bearing surfaces. Serial radiographs obtained as part of routine post-operative care will be used to evaluate osteolysis, implant stability and radiographic complications such as periprosthetic fracture. The area of each osteolytic region will be measured on the AP pelvic x-ray using Martell's Hip Analysis Suite. Computed tomography (CT) scans obtained as part of routine follow-up will be also analyzed to identify regions of acetabular osteolysis. The volume and location of each osteolytic defect identified on CT will be evaluated using three-dimensional image analysis software (Analyze, Biomedical Imaging Resource, Rochester, MN). A three-dimensional (3D) reconstruction of the pelvis, cup and acetabular osteolytic lesions will also be generated from the CT image data. This reconstruction will be oriented to simulate the AP pelvic radiographic view. Cobalt and chromium ion level data will be compiled for patients who had blood drawn to evaluate metal ion levels. The mean and median blood metal-ion levels for these patients will be calculated and the results will be compared to the metal-ion levels reported in the literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metal-on-Metal Total Hip Arthroplasties | Consecutive series of patients who had metal-on-metal primary total hip arthroplasty performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metal-on-metal primary total hip arthroplasty (DePuy ) | Device | Replacement of a patient's native hip with an artificial implant featuring a metal-on-metal articulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metal Ion Levels Per Participant | Metal ion levels include cobalt and chromium ion levels determined from tests of blood samples. Metal ion levels are reported per participant since blood samples were taken from individual participants who could have had one or both hips replaced. | At a mean of 4.2 years after primary total hip arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Cup Orientation Per Hip | Cup orientation including abduction and anteversion is determined using follow-up radiographs. Since a participant with both hips replaced could have different cup orientations for each hip, cup abduction and anteversion angles are reported per hip. | On the first post-operative anteroposterior pelvic radiograph after primary total hip arthroplasty |
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Inclusion Criteria:
Exclusion Criteria:
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A consecutive series of patients who had primary total hip arthroplasties performed at the Anderson Clinic using DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
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| Name | Affiliation | Role |
|---|---|---|
| Robert H Hopper, Jr., PhD | Anderson Orthopaedic Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anderson Orthopaedic Research Institute | Alexandria | Virginia | 22306 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15577471 | Background | MacDonald SJ. Metal-on-metal total hip arthroplasty: the concerns. Clin Orthop Relat Res. 2004 Dec;(429):86-93. doi: 10.1097/01.blo.0000150309.48474.8b. | |
| 19571083 | Background | Bozic KJ, Kurtz S, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of bearing surface usage in total hip arthroplasty in the United States. J Bone Joint Surg Am. 2009 Jul;91(7):1614-20. doi: 10.2106/JBJS.H.01220. |
| Label | URL |
|---|---|
| Website for Anderson Orthopaedic Research Institute | View source |
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No patient from the consecutive series of hip replacements performed between April 2001 and November 2002 was excluded.
For this retrospective study, the Anderson Orthopaedic Research Institute's database was used to identify a consecutive series of the first 126 patients who had 131 primary total hip arthroplasties using a Pinnacle acetabular cup, an Ultamet metal-on-metal insert and a 36-mm cobalt-chrome alloy femoral head.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metal-on-Metal Total Hip Arthroplasties | Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Overall Number of Baseline Participants is defined as the number of hips included in the study population instead of the number of participants since 5 participants had both hips replaced and objective of this study was to evaluated the outcome of each hip.
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| ID | Title | Description |
|---|---|---|
| BG000 | Metal-on-Metal Total Hip Arthroplasties | Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Metal Ion Levels Per Participant | Metal ion levels include cobalt and chromium ion levels determined from tests of blood samples. Metal ion levels are reported per participant since blood samples were taken from individual participants who could have had one or both hips replaced. | Patients who had blood drawn and analyzed for serum cobalt levels as part of routine care are included. | Posted | Median | Full Range | micrograms per liter | At a mean of 4.2 years after primary total hip arthroplasty |
|
Adverse events were evaluated from the time of surgery to a mean follow-up of 6.7±2.4 years, ranging from 0 to 10.8 years, and were compiled by querying the Anderson Orthopaedic Research Institute's database for post-operative complications and revisions.
All 131 hips were considered at risk for each of the adverse events with the following exceptions: death uses the 126 study participants; elevated ion levels uses the 65 patients with ion measurements; femoral osteolysis, stem loosening and fibrous stem stability use the 108 hips with x-rays; and pelvic osteolysis uses the 38 hips with CT scans.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metal-on-Metal Total Hip Arthroplasties | Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Component Revision | Surgical and medical procedures | Systematic Assessment | Loose stem revised at 3.0 years; Broken stem revised at 4.6 years; Metal liner & head revised at 8.5 years for femoral osteolysis, groin pain, metallosis and implant corrosion; Broken stem with metal liner & head revised at 9.6 years with corrosion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serum Metal Levels of 7 micrograms/L or higher | Blood and lymphatic system disorders | Systematic Assessment | At a mean follow-up of 4.5 years (range 1.0-6.3), 6 patients had cobalt or chromium levels of at least 7 based on results from community labs. Among these 6, median cobalt level was 26 (range 4.8-37) and median chromium level was 7.4 (range 2.9-28.9) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert H. Hopper, Jr., PhD | Anderson Orthopaedic Research Institute | (703) 619-4411 | research@aori.org |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010014 | Osteolysis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Harris Hip Score Per Hip | Harris Hip Scores are derived from a patient questionnaire and physical examination. Since a participant with both hips replaced could have different Harris Hip Scores for each hip, the Harris Hip Scores are reported per hip. | At a mean of 5.6 years after primary total hip arthroplasty |
| Osteolysis Per Hip | Osteolysis is defined as localized areas of peri-prosthetic bone loss that did not exist prior to surgery and is evaluated using radiographs and CT scans. Since a participant with both hips replaced could have a osteolysis present or absent for each hip, osteolysis is reported per hip. | At a mean of 5.6 years after primary total hip arthroplasty |
| Implant Stability Per Hip | Implant stability is classified and stable/bone ingrown, fibrous fixed or loose and evaluated using conventional radiographs. Since a participant with both hips replaced could have a different type of stability for each hip, implant stability is reported per hip. | At a mean of 5.6 years after primary total hip arthroplasty |
| Component Revision Per Hip | For implants that require a component revision, the reason for the revision is determined based on the pre-operative history and operative findings at the time of revision. Since a participant with both hips replaced could have a revision of each hip, component revision is reported per hip. | At a mean of 6.7 years after primary total hip arthroplasty |
| Patient Satisfaction Per Hip | Whether or not an individual is satisfied with the outcome of their hip arthroplasty is evaluated using a questionnaire. Since a participant with both hips replaced could have a different level of satisfaction for each hip, patient satisfaction is reported per hip. | At a mean of 5.6 years after primary total hip arthroplasty |
| 19554385 | Background | Bozic KJ, Kurtz SM, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of revision total knee arthroplasty in the United States. Clin Orthop Relat Res. 2010 Jan;468(1):45-51. doi: 10.1007/s11999-009-0945-0. Epub 2009 Jun 25. |
| 15578566 | Background | Dowson D, Hardaker C, Flett M, Isaac GH. A hip joint simulator study of the performance of metal-on-metal joints: Part II: design. J Arthroplasty. 2004 Dec;19(8 Suppl 3):124-30. doi: 10.1016/j.arth.2004.09.016. |
| 15578545 | Background | Rieker CB, Schon R, Kottig P. Development and validation of a second-generation metal-on-metal bearing: laboratory studies and analysis of retrievals. J Arthroplasty. 2004 Dec;19(8 Suppl 3):5-11. doi: 10.1016/j.arth.2004.09.017. |
| 15662304 | Background | Silva M, Heisel C, Schmalzried TP. Metal-on-metal total hip replacement. Clin Orthop Relat Res. 2005 Jan;(430):53-61. doi: 10.1097/01.blo.0000149995.84350.d7. |
| 11347829 | Background | Beaule PE, Campbell P, Mirra J, Hooper JC, Schmalzried TP. Osteolysis in a cementless, second generation metal-on-metal hip replacement. Clin Orthop Relat Res. 2001 May;(386):159-65. doi: 10.1097/00003086-200105000-00020. |
| 15637030 | Background | Willert HG, Buchhorn GH, Fayyazi A, Flury R, Windler M, Koster G, Lohmann CH. Metal-on-metal bearings and hypersensitivity in patients with artificial hip joints. A clinical and histomorphological study. J Bone Joint Surg Am. 2005 Jan;87(1):28-36. doi: 10.2106/JBJS.A.02039pp. |
| 19727991 | Background | Engh CA Jr, Ho H, Engh CA. Metal-on-metal hip arthroplasty: does early clinical outcome justify the chance of an adverse local tissue reaction? Clin Orthop Relat Res. 2010 Feb;468(2):406-12. doi: 10.1007/s11999-009-1063-8. Epub 2009 Sep 1. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| OG001 | Patients With Serum Chromium Levels | Patients were recommended to have blood drawn for evaluation of serum chromium levels if they were considered to be active or thought to be at risk for an adverse local tissue reaction. Blood was drawn at our hospital or a facility of the patient's choice. The chromium detection limit was 0.1 micrograms per liter for all labs that performed metal level assessments. Patients with undetectable chromium levels were assigned a value of zero. A patient's chromium level was considered high if it was 7 micrograms per liter or greater. |
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| Secondary | Cup Orientation Per Hip | Cup orientation including abduction and anteversion is determined using follow-up radiographs. Since a participant with both hips replaced could have different cup orientations for each hip, cup abduction and anteversion angles are reported per hip. | Cup orientation was measured for all 131 total hip replacements included in the study population. | Posted | Median | Full Range | degrees | On the first post-operative anteroposterior pelvic radiograph after primary total hip arthroplasty | hips | Participants |
|
|
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| Secondary | Harris Hip Score Per Hip | Harris Hip Scores are derived from a patient questionnaire and physical examination. Since a participant with both hips replaced could have different Harris Hip Scores for each hip, the Harris Hip Scores are reported per hip. | Posted | Median | Full Range | units on a scale | At a mean of 5.6 years after primary total hip arthroplasty | hips | Participants |
|
|
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| Secondary | Osteolysis Per Hip | Osteolysis is defined as localized areas of peri-prosthetic bone loss that did not exist prior to surgery and is evaluated using radiographs and CT scans. Since a participant with both hips replaced could have a osteolysis present or absent for each hip, osteolysis is reported per hip. | Patients who had radiographs or computed tomography (CT) scans taken as part of routine care were included. | Posted | Number | Number of hips with osteolysis | At a mean of 5.6 years after primary total hip arthroplasty | hips | Participants |
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|
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| Secondary | Implant Stability Per Hip | Implant stability is classified and stable/bone ingrown, fibrous fixed or loose and evaluated using conventional radiographs. Since a participant with both hips replaced could have a different type of stability for each hip, implant stability is reported per hip. | All hips that had a follow-up x-ray taken at least 4.75 years after their joint replacement were included. | Posted | Number | number of hips | At a mean of 5.6 years after primary total hip arthroplasty | hips | Participants |
|
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| Secondary | Component Revision Per Hip | For implants that require a component revision, the reason for the revision is determined based on the pre-operative history and operative findings at the time of revision. Since a participant with both hips replaced could have a revision of each hip, component revision is reported per hip. | Posted | Number | number of hips | At a mean of 6.7 years after primary total hip arthroplasty | hips | Participants |
|
|
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| Secondary | Patient Satisfaction Per Hip | Whether or not an individual is satisfied with the outcome of their hip arthroplasty is evaluated using a questionnaire. Since a participant with both hips replaced could have a different level of satisfaction for each hip, patient satisfaction is reported per hip. | Posted | Number | number of participants | At a mean of 5.6 years after primary total hip arthroplasty | hips | Participants |
|
|
|
| 12 |
| 131 |
| 16 |
| 131 |
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| Death | General disorders | Systematic Assessment | Patients died 3 days, 6.5 years, 7.8 years and 8.0 years after their hip replacements at ages of 77.3, 53.9, 82.0 and 72.2 respectively. Death at 3 days thought to be due to a sudden cardiac event. |
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| Irrigation & Debridement for Hematoma | Surgical and medical procedures | Systematic Assessment | After a hip aspiration to rule out infection 12 days post-operatively, patient presented with severe pain 14 days post-operatively and approximately 500 cc of dense hematoma was removed during a hip exploration. |
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| Irrigation & Debridement for Infection | Surgical and medical procedures | Systematic Assessment | Patient presented with increasing pain, fever and a wound that had begun to drain slightly serous fluid. An incision and drainage for acute infection was performed 0.05 years post-operatively. Intra-operatively cultures grew Staphylococcus aureus. |
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| Dislocation | Surgical and medical procedures | Systematic Assessment | Patient sustained a dislocation 5.5 years post-operatively that was reduced in the Emergency Room. |
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| Post-operative Fat Embolism | Vascular disorders | Systematic Assessment | Patient developed a decrease in metal status along with hypoxia and decreased blood pressure during the evening after surgery and was thought to have had a fat embolism or a reaction to post-operative medications. |
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| Femoral osteolysis on x-ray | Musculoskeletal and connective tissue disorders | Systematic Assessment | Three patients had osteolysis confined to the proximal femur that was identified on routine follow-up x-rays taken at 5.0, 5.5, and 5.6-year follow-up. |
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| Pelvic osteolysis on computed tomography scan | Musculoskeletal and connective tissue disorders | Systematic Assessment | Two patients had pelvic osteolysis identified at the cup rim on computed tomography scans. One had a 2.7 cubic centimeter inferior rim defect at 5.1 year follow-up. The other had 7.4 cubic centimeter anterior rim defect at 5.2 year follow-up. |
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| Loose stem on x-ray | Musculoskeletal and connective tissue disorders | Systematic Assessment | A loose stem was identified on a routine follow-up x-ray taken at 5.1-year follow-up. |
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| Hip Subluxation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient reported a subluxation that occurred 2.6 years post-operatively and self-reduced. |
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| Greater Trochanter Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | One patient had an asymptomatic fracture on a 6-week follow-up radiograph that was not treated. Another patient sustained a non-displaced fracture 8.0 years post-operatively secondary to a bicycle accident that also resulted in other injuries. |
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| Groin Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient presented with right groin pain 0.4 years post-operatively and was diagnosed with iliopsoas tendonitis. |
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| Thigh pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient reported intermittent thigh pain at 8.6 year follow-up that began about 2 years previously. |
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| Pubic ramus fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient sustained a pubic ramus fracture 5.4 years post-operatively that healed without intervention. |
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| Abnornal sensation with range of motion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | At a routine follow-up appointment 1.1 years post-operatively, patient reported that hip seemed to "grab" in certain positions. |
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| Fibrous stable stem | Musculoskeletal and connective tissue disorders | Systematic Assessment | Two patients were noted to have fibrous stable stems that were not bone ingrown on radiographs that were obtained 5.3 years post-operatively. |
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Any paper drafted regarding the results of the study shall be sent to Depuy Clinical Research for review and comment at least thirty (30) days before being submitted for publication; the same shall apply to abstracts, except the time for review by DePuy shall be ten (10) days. DePuy will promptly inform the authors of any changes deemed necessary to preserve the confidentiality of proprietary information or to ensure scientific accuracy.
| D001862 |
| Bone Resorption |
| D001847 | Bone Diseases |
| Loose |
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| Title | Measurements |
|---|---|
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