NCT00158418

Brief Summary

The purpose of the study is to investigate the fixation of the humeral component in total shoulder arthroplasty for primary osteoarthritis of the glenohumeral joint.Our hypothesis is that uncemented fixation of the humerus will result in better disease-specific quality of life, decreased incidence of radiographic loosening, decrease operative time and no increase in complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2002

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

January 29, 2009

Status Verified

September 1, 2005

Enrollment Period

6 years

First QC Date

September 7, 2005

Last Update Submit

January 28, 2009

Conditions

Osteoarthritis

Keywords

osteoarthritisshoulderrandomized trialcement

Outcome Measures

Primary Outcomes (5)

  • disease specific quality of life comparing the 2 groups at 2 years using several shoulder function rating scales.

  • the Western Ontario Osteoarthritis of the Shoulder Index (WOOS)

  • the Constant Score

  • American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form.

  • Short Form-12

Secondary Outcomes (2)

  • the evaluation of radiolucent lines indicative of implant loosening

  • the incidence of revision surgery complications

Interventions

Cemented Humeral StemPROCEDURE
Uncemented Humeral StemPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary osteoarthritis of the shoulder of grade III or higher (Kellgren and Lawrence modified for the shoulder
  • Patients who have failed standard conservative management of their shoulder osteoarthritis

You may not qualify if:

  • Patients with secondary OA resulting from major joint trauma, infection, avascular necrosis, cuff tear arthropathy, chronic dislocation, massive rotator cuff tear, inflammatory arthropathy, Charcot's arthropathy or previous shoulder surgery (other than arthroscopic debridement)
  • Patients with preoperative CT scans of the shoulder which show insufficient glenoid bone stock that would not allow for implantation of a glenoid prosthesis
  • Active joint or systemic infection
  • Significant muscle paralysis
  • Major medical illness (life expectancy less then 2yrs or unacceptably high operative risk)
  • Unable to speak or read English/French
  • Psychiatric illness that precludes informed consent
  • Unwilling to be followed for 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

Related Publications (35)

  • Barrack RL, Castro F, Guinn S. Cost of implanting a cemented versus cementless femoral stem. J Arthroplasty. 1996 Jun;11(4):373-6. doi: 10.1016/s0883-5403(96)80025-8.

    PMID: 8792242BACKGROUND

  • Brems JJ. Rehabilitation following total shoulder arthroplasty. Clin Orthop Relat Res. 1994 Oct;(307):70-85.

    PMID: 7924050BACKGROUND

  • Brenner BC, Ferlic DC, Clayton ML, Dennis DA. Survivorship of unconstrained total shoulder arthroplasty. J Bone Joint Surg Am. 1989 Oct;71(9):1289-96.

    PMID: 2793880BACKGROUND

  • Brown DD, Friedman RJ. Postoperative rehabilitation following total shoulder arthroplasty. Orthop Clin North Am. 1998 Jul;29(3):535-47. doi: 10.1016/s0030-5898(05)70027-4.

    PMID: 9706298BACKGROUND

  • Cameron B, Galatz L, Williams GR Jr. Factors affecting the outcome of total shoulder arthroplasty. Am J Orthop (Belle Mead NJ). 2001 Aug;30(8):613-23.

    PMID: 11520017BACKGROUND

  • Cofield RH, Daly PJ. Total shoulder arthroplasty with a tissue-ingrowth glenoid component. J Shoulder Elbow Surg. 1992 Mar;1(2):77-85. doi: 10.1016/S1058-2746(09)80124-9. Epub 2009 Feb 19.

    PMID: 22959043BACKGROUND

  • Cofield RH. Total shoulder arthroplasty with the Neer prosthesis. J Bone Joint Surg Am. 1984 Jul;66(6):899-906. doi: 10.2106/00004623-198466060-00010.

    PMID: 6736090BACKGROUND

  • Cofield RH. Uncemented total shoulder arthroplasty. A review. Clin Orthop Relat Res. 1994 Oct;(307):86-93.

    PMID: 7924051BACKGROUND

  • Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.

    PMID: 3791738BACKGROUND

  • Cuomo F, Checroun A. Avoiding pitfalls and complications in total shoulder arthroplasty. Orthop Clin North Am. 1998 Jul;29(3):507-18. doi: 10.1016/s0030-5898(05)70025-0.

    PMID: 9706296BACKGROUND

  • Fenlin JM Jr, Frieman BG. Indications, technique, and results of total shoulder arthroplasty in osteoarthritis. Orthop Clin North Am. 1998 Jul;29(3):423-34. doi: 10.1016/s0030-5898(05)70018-3.

    PMID: 9706289BACKGROUND

  • Gartsman GM, Russell JA, Gaenslen E. Modular shoulder arthroplasty. J Shoulder Elbow Surg. 1997 Jul-Aug;6(4):333-9. doi: 10.1016/s1058-2746(97)90000-8.

    PMID: 9285872BACKGROUND

  • Havig MT, Kumar A, Carpenter W, Seiler JG 3rd. Assessment of radiolucent lines about the glenoid. An in vitro radiographic study. J Bone Joint Surg Am. 1997 Mar;79(3):428-32.

    PMID: 9070534BACKGROUND

  • Hawkins RJ, Bell RH, Jallay B. Total shoulder arthroplasty. Clin Orthop Relat Res. 1989 May;(242):188-94.

    PMID: 2706849BACKGROUND

  • KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.

    PMID: 13498604BACKGROUND

  • Kelly JD Jr, Norris TR. Decision making in glenohumeral arthroplasty. J Arthroplasty. 2003 Jan;18(1):75-82. doi: 10.1054/arth.2003.50005.

    PMID: 12555187BACKGROUND

  • Lo IK, Griffin S, Kirkley A. The development of a disease-specific quality of life measurement tool for osteoarthritis of the shoulder: The Western Ontario Osteoarthritis of the Shoulder (WOOS) index. Osteoarthritis Cartilage. 2001 Nov;9(8):771-8. doi: 10.1053/joca.2001.0474.

    PMID: 11795997BACKGROUND

  • Laupacis A, Bourne R, Rorabeck C, Feeny D, Tugwell P, Wong C. Comparison of total hip arthroplasty performed with and without cement : a randomized trial. J Bone Joint Surg Am. 2002 Oct;84(10):1823-8. doi: 10.2106/00004623-200210000-00013.

    PMID: 12377914BACKGROUND

  • Matsen FA 3rd. Early effectiveness of shoulder arthroplasty for patients who have primary glenohumeral degenerative joint disease. J Bone Joint Surg Am. 1996 Feb;78(2):260-4. doi: 10.2106/00004623-199602000-00013.

    PMID: 8609117BACKGROUND

  • Matsen FA 3rd, Iannotti JP, Rockwood CA Jr. Humeral fixation by press-fitting of a tapered metaphyseal stem: a prospective radiographic study. J Bone Joint Surg Am. 2003 Feb;85(2):304-8. doi: 10.2106/00004623-200302000-00018.

    PMID: 12571309BACKGROUND

  • McElwain JP, English E. The early results of porous-coated total shoulder arthroplasty. Clin Orthop Relat Res. 1987 May;(218):217-24.

    PMID: 3568483BACKGROUND

  • Neer CS 2nd. Replacement arthroplasty for glenohumeral osteoarthritis. J Bone Joint Surg Am. 1974 Jan;56(1):1-13. No abstract available.

    PMID: 4812164BACKGROUND

  • Neer CS 2nd, Watson KC, Stanton FJ. Recent experience in total shoulder replacement. J Bone Joint Surg Am. 1982 Mar;64(3):319-37. No abstract available.

    PMID: 7061549BACKGROUND

  • Norris BL, Lachiewicz PF. Modern cement technique and the survivorship of total shoulder arthroplasty. Clin Orthop Relat Res. 1996 Jul;(328):76-85. doi: 10.1097/00003086-199607000-00014.

    PMID: 8653982BACKGROUND

  • Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13.

    PMID: 22958838BACKGROUND

  • Skirving AP. Total shoulder arthroplasty -- current problems and possible solutions. J Orthop Sci. 1999;4(1):42-53. doi: 10.1007/s007760050073.

    PMID: 9914429BACKGROUND

  • Smith KL, Matsen FA 3rd. Total shoulder arthroplasty versus hemiarthroplasty. Current trends. Orthop Clin North Am. 1998 Jul;29(3):491-506. doi: 10.1016/s0030-5898(05)70024-9.

    PMID: 9706295BACKGROUND

  • Torchia ME, Cofield RH, Settergren CR. Total shoulder arthroplasty with the Neer prosthesis: long-term results. J Shoulder Elbow Surg. 1997 Nov-Dec;6(6):495-505. doi: 10.1016/s1058-2746(97)90081-1.

    PMID: 9437598BACKGROUND

  • Weinberger M, Tierney WM, Cowper PA, Katz BP, Booher PA. Cost-effectiveness of increased telephone contact for patients with osteoarthritis. A randomized, controlled trial. Arthritis Rheum. 1993 Feb;36(2):243-6. doi: 10.1002/art.1780360216.

    PMID: 7679273BACKGROUND

  • Wirth MA, Rockwood CA Jr. Complications of shoulder arthroplasty. Clin Orthop Relat Res. 1994 Oct;(307):47-69.

    PMID: 7924048BACKGROUND

  • Wirth MA, Agrawal CM, Mabrey JD, Dean DD, Blanchard CR, Miller MA, Rockwood CA Jr. Isolation and characterization of polyethylene wear debris associated with osteolysis following total shoulder arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):29-37. doi: 10.2106/00004623-199901000-00005.

    PMID: 9973051BACKGROUND

  • Kempf JF, Walch G, Lacaze F. Results of Shoulder Arthroplasty in Primary Glenohumeral Osteoarthritis. In Shoulder Arthroplasty. Springer-Verlag, Berlin, Germany, 1999, 203-210.

    BACKGROUND

  • Kirkley A, Litchfield R, Patterson S, Lo I. Hemi vs. Total Shoulder Arthroplasty in Primary Shoulder Osteoarthritis. Annual meeting of the Canadian Orthopaedic Association, Edmonton, Alberta, June 2000.

    BACKGROUND

  • Kreidie A.,Arthritis: a crisis for Canadians. Medical Post, May 16, 2000, pp 16.

    BACKGROUND

  • Litchfield RB, McKee MD, Balyk R, Mandel S, Holtby R, Hollinshead R, Drosdowech D, Wambolt SE, Griffin SH, McCormack R. Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for osteoarthritis of the shoulder: a prospective, randomized, double-blind clinical trial-A JOINTs Canada Project. J Shoulder Elbow Surg. 2011 Jun;20(4):529-36. doi: 10.1016/j.jse.2011.01.041.

    PMID: 21570660DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Robert B Litchfield, MD, FRCSC

    Fowler Kennedy Sport Medicine Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

August 1, 2002

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

January 29, 2009

Record last verified: 2005-09

Locations

CA(1)