A Randomised Single Centre Study to Compare the Long-term Performance of Acryloc™ and Palacos® R Bone Cements in Primary Total Hip Replacement
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00208403 |
Recruitment Status :
Terminated
First Posted : September 21, 2005
Last Update Posted : March 28, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis Post-traumatic Arthritis Avascular Necrosis | Device: Acryloc™ GHV Device: Palacos R | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomised, Prospective, RSA, PMS Study Comparing Acryloc™ & Palacos R in Primary Total Hip Arthroplasty |
Study Start Date : | October 2002 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Acryloc™ GHV
|
Device: Acryloc™ GHV
A high viscosity bone cement for use in total hip replacement |
Active Comparator: 2
Palacos R
|
Device: Palacos R
A high viscosity bone cement for use in total hip replacement |
- Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment [ Time Frame: 2 Year ]
- Annual posterior (AP) and medio-lateral (ML) RSA translations [ Time Frame: Annually ]
- Merle D'Aubigne score [ Time Frame: Annually ]
- Radiographic analysis [ Time Frame: Annually ]
- Kaplan-Meier Survivorship - Revision of any component for any reason [ Time Frame: Throughout Study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
i) Male or female subjects, aged 60 to 75 years (inclusive), and with a weight of less than 100kg.
ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
iv) Subjects with non-inflammatory arthritis of the hip.
v) Subjects who require a primary total hip arthroplasty and are treated at the arthroplasty section of the orthopaedics department at the Investigational Centre.
vi) Subjects who are considered suitable for a cemented femoral stem and cemented acetabular component.
Exclusion Criteria:
i) Subjects who, in the opinion of the Investigator, have an existing condition such as malignancy, severe osteoporosis, disabling musculo-skeletal problems (other than in the hips) or any other condition that would compromise their participation and follow-up in this study.
ii) Women who are pregnant.
iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
v) Subjects who are currently involved in any injury litigation claims.
vi) Subjects undergoing corticosteroid treatment.
vii) Subjects with any condition for whom the use of conventional bone cement is contra-indicated.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208403
Norway | |
University Hospital of Trondheim | |
Trondheim, Sor-Trondelag, Norway |
Responsible Party: | DePuy International |
ClinicalTrials.gov Identifier: | NCT00208403 History of Changes |
Other Study ID Numbers: |
CT02/08 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | March 28, 2017 |
Last Verified: | March 2017 |
Keywords provided by DePuy International:
Hip Cement |
Additional relevant MeSH terms:
Osteoarthritis Necrosis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Pathologic Processes Polymethyl Methacrylate Vasodilator Agents Antimutagenic Agents Protective Agents Physiological Effects of Drugs |