Clinical trial NCT01894854: RSA Study of Furlong Evolution With and Without Collar
Official title: Evaluation of the Furlong Evolution Uncemented Hip Prosthesis With Special Emphasize on the Use of Collared Design or Not. A Prospective, Randomized Study Evaluated by RadioStereometric Analysis (RSA) and DXA.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Replacement in Osteoarthritis Patients
Keywords: Radiostereometry
Total Hip Arthroplasty
Stem design
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: JRI Orthopaedics Ltd
First posted: 2013-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to further investigate the clinical and radiological importance of design changes in cementless hip prosthesis. The investigators have earlier evaluated the classical Furlong HAC total hip prosthesis and a first design change Furlong Active. Now a further development, Furlong Evolution, is to be evaluated. This prosthesis, furthermore, comes with and without a collar, and the investigators are going to randomize between the two. The investigators hypothesize that the new design will be easier to implant and will present equal or less migration than the older designs which would imply a favourable outcome in the long term. The investigators further hypothesize that the collar play no major part for the long term migration and bone remodelling.

We will now do a 10 year follow up of the patients including RSA, DXA and PROMS


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of the hip necessitating primary hip replacement
* A femur considered suitable for uncemented fixation of the stem
* Biological age \<75 years old at the inclusion time of the study.

Exclusion Criteria:

* Rheumatoid arthritis
* Malignant disease
* Severe osteoporosis
* Earlier fracture or operation in the hip to be operated on
* Peroperative fracture
* Ongoing corticosteroid (oral) or immunosuppressive medication
* Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain.

Primary outcomes:
measure: Radiostereometric Analysis (RSA)
timeFrame: The first postoperative day, 14 days, 3 months, 1, 2, 5 and 10 years
Secondary outcomes:
measure: Dual-energy X-ray absorptiometry (DXA)
timeFrame: 14 days postoperatively and after 1, 5 and 10 years
measure: General health questionnaire
timeFrame: Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively
measure: Hip specific health questionnaire
timeFrame: Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Orthopedics, Skane University Hospital, Lund University
state: Skåne
Study officials:
affiliation: Dept of Orthopedics, Skane University Hospital, Lund University, Sweden
name: Gunnar Flivik, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belfrage O, Weber E, Sundberg M, Flivik G. Preserved periprosthetic bone stock at 5 years post-operatively with uncemented short hip stem in both collared and collarless version. Arch Orthop Trauma Surg. 2022 Nov;142(11):3489-3496. doi: 10.1007/s00402-021-04225-z. Epub 2021 Nov 29.