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Bone & Joint Open
Vol. 4, Issue 5 | Pages 306 - 314
3 May 2023
Rilby K Mohaddes M Kärrholm J

Aims

Although the Fitmore Hip Stem has been on the market for almost 15 years, it is still not well documented in randomized controlled trials. This study compares the Fitmore stem with the CementLeSs (CLS) in several different clinical and radiological aspects. The hypothesis is that there will be no difference in outcome between stems.

Methods

In total, 44 patients with bilateral hip osteoarthritis were recruited from the outpatient clinic at a single tertiary orthopaedic centre. The patients were operated with bilateral one-stage total hip arthroplasty. The most painful hip was randomized to either Fitmore or CLS femoral component; the second hip was operated with the femoral component not used on the first side. Patients were evaluated at three and six months and at one, two, and five years postoperatively with patient-reported outcome measures, radiostereometric analysis, dual-energy X-ray absorptiometry, and conventional radiography. A total of 39 patients attended the follow-up visit at two years (primary outcome) and 35 patients at five years. The primary outcome was which hip the patient considered to have the best function at two years.


Aims

The aim of this study was to compare the mid-term patient-reported outcome, bone remodelling, and migration of a short stem (Collum Femoris Preserving; CFP) with a conventional uncemented stem (Corail).

Methods

Of 81 patients who were initially enrolled, 71 were available at five years’ follow-up. The outcomes at two years have previously been reported. The primary outcome measure was the clinical result assessed using the Oxford Hip Score (OHS). Secondary outcomes were the migration of the stem, measured using radiostereometric analysis (RSA), change of bone mineral density (BMD) around the stem, the development of radiolucent lines, and additional patient-reported outcome measures (PROMs).


We evaluated an anatomical uncemented stem, SP-CL, (Static Physiologicus – CementLess) designed to facilitate insertion and to avoid stress concentration at solitary contact points in a randomized controlled trial, with use of the Corail stem as control. The SPÅ-Cl stem has been on the market since 2014 but is still not well documented.

79 patients (80 hips) were primarily recruited and 71 patients (72 hips, 36 SP-CL, 36 Corail) attended the last follow up at 2 years. The clinical evaluation included several types of PROMs with Oxford Hip Score (OHS) as primary outcome. In addition, repeated measurements of stem migration, changes in bone mineral density and development of radiolucencies were studied with RSA, DXA and conventional radiography.

At two years the Oxford Hip Score did not differ between the SP-CL and Corail stem (estimated mean difference: −0.70 (95% CI: −4.28 – 2.89). In both groups Oxford hip score had almost doubled at 3 months, continued to increase up to 6 months and was about equal at 2 years (SP-CL; median 46 (17–48), Corail; median 47 (19–48)). At 2 years the SP-CL stems showed a median distal migration of −0.23 (−5.2 – 0.1) and the Corail stems of − 0.11 (−4.4 – 0.4). The SP-CL stems showed slightly more loss of bone mineral density in Gruen region 7 (p = 0.003).

We found no difference in clinical results with use of either of the two stems. Bone mineral density loss tended to be higher with use of the SP-CL stem and the early subsidence tended to be more pronounced, which turned out to be compatible with about the same stem stability reached between 1 and 2 years. As a next step we think that the SP-CL stem should be studied in a multi-center setting, before accepted for general use.