Polarstem Versus Corail; a Comparison of Micromotion and Periprosthetic Bone Remodelling of Two Femoral Stems

NCT05815953 | Active Not Recruiting

• 1 other identifier: 27379
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A randomised controlled trial comparing a recently introduced femoral stem with an established stem for total hip arthroplasty (THA). 60 patients will be randomised into one of the two groups

1. 1.Polarstem uncemented femoral stem (Smith \& Nephew)
2. 2.Corail uncemented femoral stem (De Puy) All patients will receive a 32mm cobalt-chromium (CoCr) femoral head and an R3 acetabular cup with a 10 Mrad highly cross-linked polyethylene (XLPE) liner (Smith \& Nephew).

Conditions

Arthritis of the Hip

Keywords

Arthroplasty, Replacement; Arthroplasty, Replacement, Hip; Osteoarthritis; Osteoarthritis, Hip; Arthritis

Outcome Measures

Primary Outcomes (2)

• Migration of femoral component into the bone; Change from baseline to the prescribed time

  Radiostereometric pictures will be taken within 1, 2 or 3 days after operation (post-operative) to have a baseline and at the prescribed intervals. Migration will be measure with radiostereometric analysis (RSA) at the described intervals. Implant migration the first few years after implantation can correspond to loosening at long term.

  Baseline (1, 2 or 3 days after operation; post-operative), 3 months, 12 months, 24 months, 60 months, and 10 years postoperatively.

• Periprosthetic femoral bone mineral density (BMD); Change from baseline (postoperative) to the prescribed time

  Periprosthetic femoral bone mineral density (BMD) will be measured within 1, 2 or 3 days after operation (post-operative) to have a baseline and at the prescribed intervals using Dual x-ray absorptiometry (DXA). A DXA-machine (Lunar Prodigy, GE) located at the Department of Rheumatology at Haukeland University Hospital will be used with customized software.

  Baseline (1, 2 or 3 days after operation; post-operative), 24 months and 60 months after surgery.

Secondary Outcomes (11)

• Harris Hip Score (HHS); Change from pre-operative to the prescribed time

  Pre-operative, 3 months, 12 months , 24 months, 60 months, and 10 years after surgery.

• Hip Disability and Osteoarthritis Outcome Score (HOOS); Change from pre-operative to the prescribed time

  Pre-operative, 3 months, 12 months , 24 months, 60 months, and 10 years after surgery.

• EQ-5D-3L; Change from pre-operative to the prescribed time

  Pre-operative, 3 months, 12 months , 24 months, 60 months, and 10 years after surgery.

• EQ VAS; Change from pre-operative to the prescribed time

  Pre-operative, 3 months, 12 months , 24 months, 60 months, and 10 years after surgery.

• Hip pain; Change from pre-operative to the prescribed time

  Pre-operative, 3 months, 12 months , 24 months, 60 months, and 10 years after surgery.

Study Arms (2)

Polarstem

EXPERIMENTAL

Polarstem uncemented femoral stem

Device: Polarstem

Corail

ACTIVE COMPARATOR

Corail uncemented femoral stem

Device: Corail

Interventions

Polarstem DEVICE

Stem used in total hip replacement. Manufacturer: Smith \& Nephew Orthopaedics AG, Baar, Switzerland.

Polarstem

Corail DEVICE

Stem used in total hip replacement. Manufacturer: De Puy Int Ltd, Leeds, UK.

Corail

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• primary arthritis
• secondary arthritis
• aseptic necrosis of the femoral head
• acute hip fracture
• sequelae after hip fracture
• can use standard implants

You may not qualify if:

• active malignant disease
• rheumatoid arthritis or other generalised auto-immune arthritic disease
• BMI\>35
• insulin dependent diabetes mellitus
• chronic or recurrent infection
• liver disease
• Pagets disease
• dementia or lack of compliance for other reasons
• uncompensated cardiac- or pulmonary disease (ASA class 3 or 4)

Sponsors & Collaborators

• Helse-Bergen HF: lead
• Smith & Nephew Orthopaedics AG: collaborator

Study Sites (1)

Helse Bergen HF

Bergen, Postbox 1400, 5021, Norway

Location

Related Publications (13)

• Chandler HP, Reineck FT, Wixson RL, McCarthy JC. Total hip replacement in patients younger than thirty years old. A five-year follow-up study. J Bone Joint Surg Am. 1981 Dec;63(9):1426-34. No abstract available.

  PMID: 7320033 BACKGROUND

• Carlsson AS, Gentz CF. Mechanical loosening of the femoral head prosthesis in the Charnley total hip arthroplasty. Clin Orthop Relat Res. 1980 Mar-Apr;(147):262-70.

  PMID: 7371307 BACKGROUND

• Jones LC, Hungerford DS. Cement disease. Clin Orthop Relat Res. 1987 Dec;(225):192-206.

  PMID: 3315375 BACKGROUND

• Vervest TM, Anderson PG, Van Hout F, Wapstra FH, Louwerse RT, Koetsier JW. Ten to twelve-year results with the Zweymuller cementless total hip prosthesis. J Arthroplasty. 2005 Apr;20(3):362-8. doi: 10.1016/j.arth.2004.11.017.

  PMID: 15809956 BACKGROUND

• Hallan G, Lie SA, Furnes O, Engesaeter LB, Vollset SE, Havelin LI. Medium- and long-term performance of 11,516 uncemented primary femoral stems from the Norwegian arthroplasty register. J Bone Joint Surg Br. 2007 Dec;89(12):1574-80. doi: 10.1302/0301-620X.89B12.18969.

  PMID: 18057355 BACKGROUND

• Parvizi J, Keisu KS, Hozack WJ, Sharkey PF, Rothman RH. Primary total hip arthroplasty with an uncemented femoral component: a long-term study of the Taperloc stem. J Arthroplasty. 2004 Feb;19(2):151-6. doi: 10.1016/j.arth.2003.10.003.

  PMID: 14973856 BACKGROUND

• Soderman P, Malchau H. Is the Harris hip score system useful to study the outcome of total hip replacement? Clin Orthop Relat Res. 2001 Mar;(384):189-97. doi: 10.1097/00003086-200103000-00022.

  PMID: 11249165 BACKGROUND

• Karrholm J, Borssen B, Lowenhielm G, Snorrason F. Does early micromotion of femoral stem prostheses matter? 4-7-year stereoradiographic follow-up of 84 cemented prostheses. J Bone Joint Surg Br. 1994 Nov;76(6):912-7.

  PMID: 7983118 BACKGROUND

• Valstar ER, Gill R, Ryd L, Flivik G, Borlin N, Karrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. doi: 10.1080/17453670510041574.

  PMID: 16195075 BACKGROUND

• Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.

  PMID: 5783851 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

• Mirsky EC, Einhorn TA. Bone densitometry in orthopaedic practice. J Bone Joint Surg Am. 1998 Nov;80(11):1687-98. doi: 10.2106/00004623-199811000-00018. No abstract available.

  PMID: 9840640 BACKGROUND

• Bourne RB, McCalden RW, Naudie D, Charron KD, Yuan X, Holdsworth DW. The next generation of acetabular shell design and bearing surfaces. Orthopedics. 2008 Dec;31(12 Suppl 2):orthosupersite.com/view.asp?rID=37179.

  PMID: 19298027 BACKGROUND

Related Links

• Australian Orthopaedic Association National Joint Replacement Registry. Annual report 2015
• Malchau, Henrik 1995, Doctoral Theses: "On the importance of stepwise introduction of new hip implant technology : assessment of total hip replacement using clinical evaluation, radiostereometry, digitised radiography and a national hip registry"

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Hip; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Geir Hallan, MD; PhD

  Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway

  STUDY DIRECTOR

• Ove N Furnes, MD; PhD

  Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway

  STUDY CHAIR

• Torbjørn B Kristensen, MD; PhD

  Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway

  STUDY CHAIR

• Jan-Erik Gjertsen, MD; PhD

  Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway

  STUDY CHAIR

• Paul J Høl, PhD

  Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway

  STUDY CHAIR

• Irene O Moldestad, MSc

  Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Computer generated block randomization for each participating surgeon. The envelopes are sequentially numbered, opaque and sealed. The surgeon is not blinded, but the patient and the physiotherapist that do the clinical follow-ups are.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: April 18, 2023
• Study Start: June 20, 2017
• Primary Completion: January 31, 2025
• Study Completion (Estimated): January 31, 2033
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)