Ceramic-on-ceramic total hip arthroplasty is superior to metal-on-conventional polyethylene at 20-year follow-up: A randomised clinical trial.

BACKGROUND: Metal-on-conventional polyethylene (MoPc) bearing wear-related biological reactions in total hip arthroplasty (THA) continue to raise concerns among young, active patients. Ceramic-on-ceramic (CoC) bearings may offer improved outcomes in this patient population. QUESTIONS/PURPOSES: The aim of this study was to determine if, more than 20years postoperatively, there is a difference between MoPc and CoC THA in terms of (1) survivorship, (2) related complications, (3) radiographic signs of wear, and (4) functional scores. HYPOTHESIS: CoC bearing THAs have superior clinical results compared to MoPc THAs. PATIENTS AND METHODS: A total of 140 hips in 116 patients with a mean age of 42years were randomised to receive CoC or MoPc THA between 1996 and 2001. Sixty-nine hips in 58 patients received MoP and 71 hips in 68 patients received CoC. Revision rate, WOMAC score, and radiological signs of osteolysis and loosening were compared at last follow-up. RESULTS: After a mean follow-up of 21years (19-23), 40 patients (48 THAs; 34%) had died and 6 patients (6 THAs; 4%) were lost to follow-up. Aseptic revision rate was significantly higher in the MoPc group (17/69; 24.6%) versus CoC (2/71; 2.8%; p<0.001). Kaplan-Meier survivorship estimator with revision for aseptic reasons was 73.6% (95% CI: 63.3-84.9%) for MoPc and 96.9% (95% CI: 92.8-100%) for CoC (p<0.001). On radiographic evaluation, 13% (3/23) MoPc were considered loose versus no CoC, and 61% (14/23) MoPc versus 6% (2/33) CoC showed osteolytic signs (p<0.001). CoC had better mean WOMAC scores than MoPc (11.0 vs. 19.4; p=0.048). No ceramic fracture was observed. CONCLUSION: In this RCT, CoC bearings provided excellent results and were safer than MoPc bearings at more than 20-year follow-up. The long-term in vivo behaviour of CoC bearing makes it a great THA option for middle-aged patients and should be compared to newer polyethylene bearings. LEVEL OF EVIDENCE: I.

Alumina on alumina versus metal on conventional polyethylene: a randomized clinical trial with 9 to 15 years follow-up.

We report the long-term results of a randomized clinical trial that compares, in total hip arthroplasty in a young population, metal-on-conventional polyethylene and alumina-on-alumina ceramic bearings. One hundred and forty hips in 116 patients were randomized. Re-operation, revision rate, clinical scores, and radiological signs of osteolysis and loosening were compared at average follow-up of 123 (9-15) years. At final FU, 107 hips were available for clinical evaluation. Eight (11.6%) revisions were performed in the polyethylene group versus 1 (1.4%) in the ceramic group (p = 0.017). All revisions in the polyethylene group were related to bearing wear: 4 for aseptic loosening with severe osteolysis, 1 for polyethylene induced compressive granulomatous tumor, and 3 for severe liner wear. The only revised case from the ceramic group was secondary to mechanical stem loosening. Mean annual polyethylene wear was 0.19mm/year; wear was not measurable in the ceramic group. Our study confirms, in the long-term, the superiority of ceramic-on-ceramic pairing in comparison to metal-on-conventional polyethylene and supports their use in young, active patients.

Comparison of alumina-alumina to metal-polyethylene bearing surfaces in THA: a randomized study with 4- to 9-years follow-up.

We report the clinical and radiological results of 140 primary THAs, randomized to receive metal-polyethylene or alumina-alumina bearing surfaces. At last follow-up (average 79 months), no significant difference was found on clinical scores (WOMAC and Merle D'Aubigné) between the two groups. However, linear wear of 1 mm or more of the liner was observed in 89% (50/56) of polyethylene cases, whereas no measurable wear was noted in the alumima-on-alumina group. Calcar resorption was noted in 34% (19/56) of cases in the polyethylene group versus 6% (3/51) in the alumina group. Although no aseptic loosening was present in either group, 2 hips in the polyethylene group underwent revision for severe liner wear, and 2 more are pending. No specific complication was associated with alumina components. This study is in line with other reports indicating that alumina-alumina bearing surfaces have better wear properties than metal-on standard polyethylene and should be considered for THA in young and active patients.

Randomized, placebo-controlled, double-blind clinical trial evaluating the treatment of plantar fasciitis with an extracoporeal shockwave therapy (ESWT) device: a North American confirmatory study.

Despite numerous publications and clinical trials, the results of treatment of recalcitrant chronic plantar fasciitis with extracorporeal shockwave therapy (ESWT) still remain equivocal as to whether or not this treatment provides relief from the pain associated with this condition. The objective of this study was to determine whether extracorporeal shock wave therapy can safely and effectively relieve the pain associated with chronic plantar fasciitis compared to placebo treatment, as demonstrated by pain with walking in the morning. This was set in a multicenter, randomized, placebo-controlled, double-blind, confirmatory clinical study undertaken in four outpatient orthopedic clinics. The patients, 114 adult subjects with chronic plantar fasciitis, recalcitrant to conservative therapies for at least 6 months, were randomized to two groups. Treatment consisted of approximately 3,800 total shock waves (+/-10) reaching an approximated total energy delivery of 1,300 mJ/mm(2) (ED+) in a single session versus placebo treatment. This study demonstrated a statistically significant difference between treatment groups in the change from baseline to 3 months in the primary efficacy outcome of pain during the first few minutes of walking measured by a visual analog scale. There was also a statistically significant difference between treatments in the number of participants whose changes in Visual Analog Scale scores met the study definition of success at both 6 weeks and 3 months posttreatment; and between treatment groups in the change from baseline to 3 months posttreatment in the Roles and Maudsley Score. The results of this study confirm that ESWT administered with the Dornier Epos Ultra is a safe and effective treatment for recalcitrant plantar fasciitis.

Reducing reactions to blood donation with applied muscle tension: a randomized controlled trial.

BACKGROUND: Unpleasant blood donation-related symptoms may discourage otherwise healthy, altruistic individuals from becoming repeat donors. This study examined a behavioral technique called applied muscle tension (AMT) that might reduce reactions. STUDY DESIGN AND METHODS: A total of 605 donors at mobile clinics were assigned to either an AMT treatment condition, a no-treatment control condition, or a placebo control condition. AMT involves repeated tensing of major muscles and was taught using an instructional video. Participants in the placebo control group watched the same video but were told to practice the technique only from the time they got on the donation chair until insertion of the needle, without being told that reactions are unlikely during this period. RESULTS: There were no differences between men assigned to the three conditions. Women donors assigned to the AMT condition reported significantly fewer donation-related symptoms, required less chair reclining for reactions, and were more likely to produce a full unit of blood than women in both the no-treatment and placebo control conditions. Women in the AMT condition also said they would be more likely to recommend it to a friend who was going to give blood, but there were no significant effects of AMT on the rated probability of giving blood again or blood pressure change. CONCLUSIONS: Although it was not universally effective and the mechanisms of its effects are unclear, AMT is a simple behavioral technique that may be useful in reducing reactions to blood donation.

On-site training in applied muscle tension to reduce vasovagal reactions to blood donation.

Vasovagal reactions significantly complicate the blood collection process and, more importantly, discourage people who might otherwise donate blood many times from returning. Applied muscle tension is a simple behavioral technique that may reduce vasovagal reactions by maintaining blood pressure. It has been successfully used to treat patients with blood and injury phobias, but has not been applied in the more general, time-limited context of blood collection clinics. Thirty-seven inexperienced blood donors (maximum number of prior donations = 2) attending mobile blood collection clinics were asked to practice applied tension after watching a 2-min instructional video presented on a notebook computer. They were compared with 94 untreated donors with similar donation experience and 47 more experienced blood donors. Treatment reduced the number of symptoms reported on a postdonation questionnaire. It also significantly reduced the amount of medical treatment required (chair reclining) among those who practiced applied tension for the entire period they were in the donation chair.