A Comparative Study of Stem and Cup Fixation and Polyethylene Wear

NCT04064723 | Active Not Recruiting DMC

• 1 other identifier: LCU-DeltaTT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled study comparing two types of cementless femoral stems (LCU and Corail) and two types of acetabular components (DeltaTT and Pinnacle Duofix) in primary total hip arthroplasty. Primary outcome are component migration measured by RSA, wear and patient reported outcome. Patients are evaluated up to 15 years postoperatively.

Conditions

Osteoarthritis, Hip

Keywords

Osteoarthritis; Total hip arthroplasty; Uncemented total hip arthroplasty

Outcome Measures

Primary Outcomes (3)

• Cup Migration

  Migration measured in millimetres per year with radiostereometric (RSA) analysis of radiographs. Radiostereometric analysis (RSA) is a stereo X-ray technique used in clinical research studies to evaluate micro-motion and wear of orthopaedic implants within bone. The method has a high accuracy and precision. Technical requirements include the need for implanted marker beads and radiograph view angles determined by a calibration cage.

  1-15 years

• Femoral stem migration

  Migration measured in millimetres per year with radiostereometric (RSA) analysis of radiographs.

  1-15 years

• Wear

  The size of the femoral component penetration into the polyethylene measured in millimeters per year and the volumetric annual wear millimetres with radiostereometric (RSA) analysis of radiographs.

  1-15 years

Secondary Outcomes (7)

• Movement between liner and acetabular components

  1-15 years

• Patient reported outcome measurement

  1-15 years

• Harris Hip Score

  1-15 years

• EQ5D

  1-15 years

• Visual Analog Scale

  1-15 years

Study Arms (2)

Stem components

ACTIVE COMPARATOR

Randomization between two stem components. LCU or Corail stem.

Device: Randomization between prosthetic components

Cup components

ACTIVE COMPARATOR

Randomization between two cup components. DeltaTT or Pinnacle cup.

Device: Randomization between prosthetic components

Interventions

Randomization between prosthetic components DEVICE

Patients are randomized between two types of stem components and two types of cup components in total hip arthroplasty. Thus randomized between 4 different groups.

Cup components; Stem components

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary or secondary osteoarthritis of the hip
• Male and non-pregnant female patients aged 18 to 70 years of age
• Type A or B femur
• Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up

You may not qualify if:

• BMI under 18 and over 35
• Inflammatory arthritis
• Osteoporosis
• Paget's disease
• Grossly abnormal hip anatomy (severe dysplasia)
• Previous operations in the same hip
• Presence of malignancy
• Patients who, as judged by the surgeon, are mentally incompetent or are reasonable unlikely to be compliant with the requirements of the study
• Patient is female of child-bearing age and not taking contraceptive precautions

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Volker TC Otten

Umeå, Västerbotten County, 901 89, Sweden

Location

Related Publications (13)

• Joglekar SB, Rose PS, Lewallen DG, Sim FH. Tantalum acetabular cups provide secure fixation in THA after pelvic irradiation at minimum 5-year followup. Clin Orthop Relat Res. 2012 Nov;470(11):3041-7. doi: 10.1007/s11999-012-2382-8.

  PMID: 22576931 BACKGROUND

• Goriainov V, Jones A, Briscoe A, New A, Dunlop D. Do the cup surface properties influence the initial stability? J Arthroplasty. 2014 Apr;29(4):757-62. doi: 10.1016/j.arth.2013.07.007. Epub 2013 Nov 22.

  PMID: 24269067 BACKGROUND

• Engh CA Jr, Stepniewski AS, Ginn SD, Beykirch SE, Sychterz-Terefenko CJ, Hopper RH Jr, Engh CA. A randomized prospective evaluation of outcomes after total hip arthroplasty using cross-linked marathon and non-cross-linked Enduron polyethylene liners. J Arthroplasty. 2006 Sep;21(6 Suppl 2):17-25. doi: 10.1016/j.arth.2006.05.002.

  PMID: 16950057 BACKGROUND

• Campbell D, Mercer G, Nilsson KG, Wells V, Field JR, Callary SA. Early migration characteristics of a hydroxyapatite-coated femoral stem: an RSA study. Int Orthop. 2011 Apr;35(4):483-8. doi: 10.1007/s00264-009-0913-z. Epub 2009 Dec 13.

  PMID: 20012862 BACKGROUND

• Karrholm J, Herberts P, Hultmark P, Malchau H, Nivbrant B, Thanner J. Radiostereometry of hip prostheses. Review of methodology and clinical results. Clin Orthop Relat Res. 1997 Nov;(344):94-110.

  PMID: 9372762 BACKGROUND

• Baad-Hansen T, Kold S, Nielsen PT, Laursen MB, Christensen PH, Soballe K. Comparison of trabecular metal cups and titanium fiber-mesh cups in primary hip arthroplasty: a randomized RSA and bone mineral densitometry study of 50 hips. Acta Orthop. 2011 Apr;82(2):155-60. doi: 10.3109/17453674.2011.572251. Epub 2011 Mar 25.

  PMID: 21434845 BACKGROUND

• Bitsch RG, Loidolt T, Heisel C, Ball S, Schmalzried TP. Reduction of osteolysis with use of Marathon cross-linked polyethylene. A concise follow-up, at a minimum of five years, of a previous report. J Bone Joint Surg Am. 2008 Jul;90(7):1487-91. doi: 10.2106/JBJS.F.00991.

  PMID: 18594097 BACKGROUND

• Madanat R, Makinen TJ, Aro HT, Bragdon C, Malchau H. Adherence of hip and knee arthroplasty studies to RSA standardization guidelines. A systematic review. Acta Orthop. 2014 Sep;85(5):447-55. doi: 10.3109/17453674.2014.934187. Epub 2014 Jun 23.

  PMID: 24954489 BACKGROUND

• van der Voort P, Pijls BG, Nieuwenhuijse MJ, Jasper J, Fiocco M, Plevier JW, Middeldorp S, Valstar ER, Nelissen RG. Early subsidence of shape-closed hip arthroplasty stems is associated with late revision. A systematic review and meta-analysis of 24 RSA studies and 56 survival studies. Acta Orthop. 2015;86(5):575-85. doi: 10.3109/17453674.2015.1043832.

  PMID: 25909455 BACKGROUND

• Wolf O, Mattsson P, Milbrink J, Larsson S, Mallmin H. Periprosthetic bone mineral density and fixation of the uncemented CLS stem related to different weight bearing regimes: A randomized study using DXA and RSA in 38 patients followed for 5 years. Acta Orthop. 2010 Jun;81(3):286-91. doi: 10.3109/17453674.2010.487238.

  PMID: 20446828 BACKGROUND

• Drobniewski M, Borowski A, Synder M, Sibinski M. Results of total cementless hip joint arthroplasty with Corail stem. Ortop Traumatol Rehabil. 2013 Jan-Feb;15(1):61-8. doi: 10.5604/15093492.1032797.

  PMID: 23510822 BACKGROUND

• Louboutin L, Viste A, Desmarchelier R, Fessy MH. Long-term survivorship of the Corail standard stem. Orthop Traumatol Surg Res. 2017 Nov;103(7):987-992. doi: 10.1016/j.otsr.2017.06.010. Epub 2017 Aug 1.

  PMID: 28778624 BACKGROUND

• Buttaro MA, Onativia JI, Slullitel PA, Andreoli M, Comba F, Zanotti G, Piccaluga F. Metaphyseal debonding of the Corail collarless cementless stem: report of 18 cases and case-control study. Bone Joint J. 2017 Nov;99-B(11):1435-1441. doi: 10.1302/0301-620X.99B11.BJJ-2017-0431.R1.

  PMID: 29092981 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Volker TC Otten, M.D., Ph.D

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control: Corail femoral stem and Pinnacle cup with Marathon XLPE neutral liner (DePuy Orthopaedics). Study: LCU femoral stem (Waldemar Link GmbH) and Delta TT cup with Neutral XLPE liner (Lima Corporate).

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: August 22, 2019
• Study Start: January 1, 2015
• Primary Completion: September 30, 2020
• Study Completion (Estimated): November 30, 2033
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)