Uvehammer 2007.
Methods | RCT. Unknown randomization technique. Blinding not stated. | |
Participants | Inclusion: Osteoarthrosis: 50 participants (54 knees). All of the femoral components were manufactured with an 80 mm stem and were only available in one size (size 2/medium). This made the series more homogeneous regarding biomechanical factors but excluded selection of participants with larger or smaller knees. Average age: 72 years. Fifteen participants were lost (16 knees). | |
Interventions | The femoral component fixation (cemented or uncemented with hydroxyapatite) and prosthesis design (three variations of the Freeman‐Samuelson knee replacement (Finsbury Orthopaedics Ltd): one with a rotating tibial insert, one with a medial femoral condyle representing part of a sphere articulating against a corresponding concave tibial polyethylene insert (FS1000), and the original standard version) were randomized, and the participants were randomized into one of the six treatment options. All of the tibial components were cemented. In 44 of the knees, a patellar component was inserted. Refobacin‐Palacos R bone cement (Biomet Orthopaedics Inc., Warsaw, Indiana) was prepared by vacuum mixing. |
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Outcomes | RSA (absolute values of rotation around the three orthogonal axes), HKA, and Hospital for Special Surgery knee score. | |
Notes | Duration of follow‐up: 2 years. No difference between the two types of fixation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | This item was not mentioned in the trial report. |
Allocation concealment (selection bias) | Low risk | Sealed envelopes were opened before the operation. |
Was the patient blinded? | Unclear risk | This item was not mentioned in the trial report. |
Was the surgeon blinded? | High risk | It is impossible to blind the surgeon to prosthesis fixation. |
Was the outcome assessor blinded? | Unclear risk | This item was not mentioned in the trial report. |
Was the withdrawal/drop‐out rate described, acceptable (<20%), and comparable in both groups? | Low risk | The withdrawal/drop‐out rate was described, was comparable in both groups and was not acceptable. Missing outcome data were balanced in numbers among intervention groups with similar reasons for missing data among the groups. |
Selective reporting (reporting bias) | Low risk | The study protocol is available, and all of the study’s prespecified (primary and secondary) outcomes that were of interest in the review were reported in the prespecified manner. |
RCT = randomoized controlled trial
RSA = roentgen stereophotogrammetric analysis
MTPM = maximum total point motion
RA = rheumatoid arthritis
HKA = hip‐knee‐ankle‐angle