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Trial registered on ANZCTR

Registration number

ACTRN12613000335796

Ethics application status

Approved

Date submitted

23/03/2013

Date registered

26/03/2013

Date last updated

24/03/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Randomised controlled trial of cemented and uncemented fixation of primary total hip replacement

Scientific title

In persons older than 50 undergoing total hip replacement surgery for primary osteoarthritis, is there any difference in hip pain and function at two years and longer-term follow-up with cemented versus cementless prosthesis fixation?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1140-9894

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

primary osteoarthritis of the hip

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Uncemented total hip replacement surgery with a cobalt-chrome alloy porous coated hemispherical PCA acetabular component with two lateral fixation lugs for supplementary fixation (Howmedica International, London) and a collarless cobalt chrome alloy PCA femoral stem with sintered porous beads coating the proximal one third of the stem circumferentially (Howmedica International, London), performed using standard surgical tehniques and a posterior surgical approach. Patients monitored regularly following the procedure by clinical and radiographic review, including at 2 years for primary study hypothesis and over the long-term until revision of the components, death or lost-to-follow-up.

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Cemented total hip replacement surgery with an all-polyethylene or metal-backed ultrahigh molecular weight polyethylene Exeter acetabular component (Howmedica International, London) and a collarless double tapered polished stainless steel Exeter stem (Howmedica International, London), performed using standard surgical techniques and a posterior surgical approach. Patients monitored regularly following the procedure by clinical and radiographic review, including at 2 years for primary study hypothesis and over the long-term until revision of the components, death or lost-to-follow-up.

Control group

Active

Outcomes

Primary outcome [1]

Hip pain and function, defined by the Harris hip score (Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. J Bone Joint Surg. 1969;51A:737-55)

Timepoint [1]

The primary outcome will be assessed at 2 years after surgery to test the primary hypothesis

Secondary outcome [1]

Hip pain and function, defined by the Harris Hip Score, over long term follow-up after surgery

Timepoint [1]

Review periods following surgery 5 year, 8 year, 11 year, 15 year, 20 year, 25 year

Secondary outcome [2]

Radiographic loosening as assessed from plain X-rays based on migration of prostheses and presence of radiolucencies. Measurements of prosthesis position and change in position over time (migration) made using templates adjusted for magnification. Radiographic loosening was determined using the classification systems of Hodgkinson for the acetabular components (Hodgkinson JP et al. Clin Orthop Rel Res.1988; 228:105-9) and Harris and Malchau for the cemented stems (Harris WH et al. J Bone Joint Surg.1982;64A:1063-7; Malchau H et al. Acta Orthop Scand. 1995;66:418-24.) and Engh for the uncemented stems (Engh CA et al. Clin Orthop Rel Res. 1988;235:91-110).

Timepoint [2]

Review periods following surgery 5 year, 11 year, 15 year, 20 year, 25 year

Secondary outcome [3]

Radiographic osteolysis defined off plain X-ray as an area of bone that appeared less radio-dense than the surrounding bone, with a border clear enough that it could be outlined according to Engh (Engh AC et al J Arthroplasty. 2002;17:752-9)

Timepoint [3]

Review periods following surgery 5 year, 11 year, 15 year, 20 year, 25 year

Secondary outcome [4]

Prosthesis survival to endpoint revision total hip replacement surgery requiring removal of prostheses for loosening confirmed at surgery. All reoperations documented prospectively to determine months to revision surgery and reason for revision. Survival analysis is undertaken using Kaplan-Meier methods.

Timepoint [4]

At longest time point when a minimum of 20 hips continue to be followed up (ie have not been censored out of the study due to patient death, lost to follow-up or removal of the prosthesis at revision total hip replacement surgery)

Secondary outcome [5]

Prosthesis survival to endpoint revision total hip replacement surgery requiring removal of prostheses for reasons other than loosening confirmed at surgery. This includes, but not restricted to, infection, bone fracture around the prosthesis, hip instability. All reoperations documented prospectively to determine months to revision surgery and reason for revision. Survival analysis is undertaken using Kaplan-Meier methods.

Timepoint [5]

Eligibility

Key inclusion criteria

Diagnosis of primary osteoarthritis of hip
Minimum age of 50 years
Aged less than 72 for males and 77 for females which were the population age cut-offs for a life expectancy of at least 10 years as of the start of the trial.

Minimum age

50 Years

Maximum age

77 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Previous surgery or trauma to the hip
Previous infection of the hip
Paget’s disease
Acetabular dysplasia
Known allergy to cobalt-chrome
Medical conditions with resultant life expectancy of less than 10 years
Unable to attend regular outpatient reviews for at least two years.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The study was undertaken as a parallel-arm RCT. All patients planned for primary THA by two senior consultant surgeons were screened for inclusion. Consenting patients were randomized preoperatively to undergo either cemented total hip replacement with the Exeter prostheses or uncemented total hip replacement with the PCA prosthesis, using a pre-prepared, non-concealed randomization sequence, and an allocation ratio of 1:1.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Random number generator.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Intraoperative inclusion criteria included availability of suitably sized prostheses at surgery and, for the uncemented group, excellent fit of the femoral stem, defined as less than a 2mm gap between the stem and cortical bone determined by visual inspection, no interface movement following insertion of the trial component and subjective assessment of good fit and fill on an intraoperative radiograph.

Phase

Phase 3 / Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size: To test the hypothesis, a minimum of 30 patients per group were required to detect a difference of 20 out of a possible 100 points (0.2) of the Harris Hip Score 14, as determined by independent samples test with adjustment for non-parametric analysis, effect size 0.66, power 0.8, alpha 0.05. Minimum sample size was increased by 33% to 40 per group to allow for longer follow-up and unanticipated death or loss to follow-up.
Statistical analyses: Mann-Whitney U test was used to compare the Harris hip score between the groups at two years.
Linear mixed effects models were used to compare Harris hip scores over time between the groups.
Logistic generalised estimating equations were used to compare the odds of a good Harris hip pain score (44 or 40) over time between groups. Variable effect predictors were preoperative age, gender, body mass index and Charnley grade, and, for the cemented group, metal backing of the acetabular component and femoral head modularity.
Kaplan-Meier survival analysis was performed using the endpoint major revision. The logrank test was used to compare survival curves.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

2/06/1986

Actual

2/06/1986

Date of last participant enrolment

Anticipated

Actual

3/08/1992

Date of last data collection

Anticipated

Actual

31/12/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment hospital [2]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5042 - Bedford Park

Recruitment postcode(s) [2]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Adelaide Bone and Joint Research Foundation

Address [1]

c/- Department of Orthopaedics & Trauma
L4 Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

The Australian Orthopaedic Association Research Fund

Address [2]

Level 12
45 Clarence Street
Sydney NSW 2000
Australia

Country [2]

Australia

Funding source category [3]

University

Name [3]

Flinders University of South Australia

Address [3]

GPO Box 2100
Adelaide 5001 SA

Country [3]

Australia

Funding source category [4]

Charities/Societies/Foundations

Name [4]

Royal Australasian College of Surgeons

Address [4]

College of Surgeons' Gardens
250-290 Spring Street
East Melbourne VIC 3002 Australia

Country [4]

Australia

Funding source category [5]

Hospital

Name [5]

Royal Adelaide Hospital Research Fund

Address [5]

Royal Adelaide Hospital
North Terrace
Adelaide SA 5000

Country [5]

Australia

Primary sponsor type

Individual

Name

Professor Donald W Howie

Address

Department of Orthopaedics and Trauma
L4 Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Other collaborator category [1]

Individual

Name [1]

Mr Colin Steele-Scott

Address [1]

Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Flinders Medical Centre Ethics Committee

Ethics committee address [1]

Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

04/12/1985

Ethics approval number [1]

113/85

Summary

Brief summary

Uncemented porous coated prostheses were introduced in the early 1980s as a possible answer to the complications of loosening of cemented prostheses and osteolysis. At that time, there was a lack of comparative studies, there being only one published randomised controlled trial of cemented and uncemented THR. In that trial, worse early pain scores were reported for uncemented THR.   Therefore a randomised controlled trial was undertaken to examine the hypothesis that there are no important differences in hip pain and function following cemented and uncemented primary total hip replacement for osteoarthritis in middle-aged patients.

Trial website

Not applicable

Trial related presentations / publications

Publications:
1. Cemented Exeter versus cementless PCA total hip arthroplasty.  11th Singapore Orthopaedic Association Meeting and Symposium on Hip and Knee Arthroplasty, Singapore, September 1988.
2. Preliminary results, trial of cementless versus cemented total hip arthroplasty. Implant-Bone Interface Symposium. Midhurst, United Kingdom, May 1989.
3. Cemented versus cementless hip arthroplasty. Annual Scientific Meeting, Australian Orthopaedic Association, Canberra. Evelyn Hamilton Award for best scientific paper, Sept 1989.
4. Randomised comparison of cemented versus cementless arthroplasty. Controversies in Orthopaedics in the 1990's, Australian Orthopaedic Association, Continuing Education Meeting, Adelaide, Nov 1989.
5. Cemented versus cementless hip arthroplasty.The 9th Western Pacific Orthopaedic Association Meeting, Singapore, Nov 1989.
6. Cemented versus cementless hip arthroplasty  SICOT XVIII World Congress, Montreal, Canada, Sept 1990.
7. Howie DW, Dracopoulos GC, McGee MA, Steele Scott CM. Preliminary Results:  Trial of cementless versus cemented total hip arthroplasty. In:  Older J. ed. Implant Bone Interface.  pp 149-150.  Springer Verlag, Berlin. 1990. 
8. Similar early functional outcome in a randomised clinical trial of cemented versus non-cemented total hip arthroplasty.  The Ninth combined Meeting of the Orthopaedic Associations of the English Speaking World.  Toronto, Jun 1992.
9. Results of a randomised trial of cemented versus non-cemented total hip arthroplasty after two to six years. Australian Orthopaedic Association Annual Scientific Meeting.  Hobart, Sept 1992.
10. A randomised trial of cemented versus non-cemented total hip replacement.  International Hip Society (Closed Meeting).  Seoul, Korea. Aug 1993.
11 Cemented versus cementless total hip replacement in middle aged patients undergoing immediate full weight bearing.  (Poster) American Academy of Orthopaedic Surgeons, New Orleans, Feb 1994
12. Mid-term results of a RCT of cemented vs uncemented total hip arthroplasty (Poster)  10th Combined Orthopaedic Associations, Auckland, Feb 1998.
13. Long term results of cemented and uncemented THR. 14th Annual Smith & Nephew Winter Meeting, Current Concepts in Arthroplasty, Trauma & Sports Injuries, Gold Coast, Jul 2001.
14. Cement or cementless: the long term results. Arthroplasty: New Frontiers Conference, Wellington, NZ, Nov 2001.
15. Long term results of cemented versus cementless fixation of THR.  4th Hip Section Mtg of the Asia Pacific Orthopaedic Association/22nd Annual Congress of the Hong Kong Orthopaedic Association, Hong Kong, Nov 2002.
16. Long-Term Results of a Randomised Clinical Trial of Cemented Versus Uncemented Fixation of Total Hip Replacement. 70th Annual Scientific Meeting, Australian Orthopaedic Association.  Adelaide, Oct 2010.
17. Long-term results of a Randomised Controlled Trial of Cemented and Uncemented Total Hip Replacement. Talk & Poster. Orthopaedic Research Society, California, USA. January 2011.

Public notes

Contacts

Principal investigator

Name

Prof Donald W

Address

Department of Orthopaedics & Trauma
L4 Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000

Country

Australia

Phone

+61 8 8222 5563

Fax

donald.howie@health.edu.au

Contact person for public queries

Name

Margaret McGee

Address

Department of Orthopaedics & Trauma
L4 Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000

Country

Australia

Phone

+61 8 8222 4079

Fax

margaret.mcgee@adelaide.edu.au

Contact person for scientific queries

Name

Donald Howie

Address

Department of Orthopaedics & Trauma
L4 Bice Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000

Country

Australia

Phone

+61 8 8222 5563

Fax

donald.howie@health.sa.gov.au

No information has been provided regarding IPD availability

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No Supporting Document Provided

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