Aims

The rate of dislocation when traditional single bearing implants are used in revision total hip arthroplasty (THA) has been reported to be between 8% and 10%. The use of dual mobility bearings can reduce this risk to between 0.5% and 2%. Dual mobility bearings are more expensive, and it is not clear if the additional clinical benefits constitute value for money for the payers. We aimed to estimate the cost-effectiveness of dual mobility compared with single bearings for patients undergoing revision THA.

A randomized trial was designed to compare the outcome of ceramic-on-ceramic with ceramic on conventional polyethylene. These patients have been followed for 15 years.

58 hips in 57 patients under 60 years of age were randomized into one of two groups. Patients were blinded to the type of hip they received. Both groups of patients were treated routinely with prophylactic peri-operative antibiotics and low molecular weight Heparin. All patients were seen at six weeks, three months and annually after surgery. Clinical and radiologic assessment was carried out at each visit.

Fifty-eight hips were available for analysis, 28 in the CoP group and 29 patients in the CoC group. Mean age of both groups was less than 45 years.

There were seven revisions (16%) among the 58 patients enrolled in the study. In the CoP group four patients underwent revision with head and liner exchange for eccentric polyethylene wear 16 years post-implantation. In the CoC group one patient had a cup revision at 15 years for acute aseptic instability of the acetabulum; two additional patients in the CoC group had femoral head exchange, one for fracture and one for trunnion corrosion. Both occurred 14 years after the index surgery.

Functional outcome scores showed no difference between the two groups at 15 years. Radiographically there was a statistically difference in wear between the two groups.

This study demonstrates that both ceramic-on-ceramic and ceramic-on-polyethylene produce satisfactory functional results with low revision rates in young patients.

Several implants have a proven track record of durability and function in patients over many years. As manufacturers' patents expire it is understandable that cheaper generic copies would be considered. There is currently no established, independent method of determining design equivalence between generic and branded orthopaedic implants.

We acquired 10 boxed, as manufactured components consisting of the generic OptiStem XTR model (n=5) and branded Exeter (n=5) femoral stems. Two examiners were blinded to the implant design and independently measured the mass, volume, trunnion surface topography, roughness, trunnion cone angle, CCD angle and femoral offset using peer-reviewed methods. We then compared the stems using these parameters.

We found that the OptiStems (1) were lighter (p<0.001) (2) had a rougher trunnion surface (p<0.001) with a greater spacing and depth of the machined threads (p<0.001), (3) had greater trunnion cone angles (p=0.007) and (4) a smaller radius at the top of the trunnion (p=0.007). There was no difference for stem volume (p=0.643), CCD angle (p=0.788) or offset (p=0.993).

This study is the first independent investigation of the equivalence of a generic orthopaedic implant to its branded design. We found a clear difference in trunnion roughness, trunnion cone angle and radius, and implant mass when comparing the two generic and branded stem designs. All implants require standard regulatory processes to be followed. It does not appear feasible that generic implants can be manufactured to predictability guarantee the same performance as generic drugs.

We found a number of physical differences between the generic and branded implants. Whilst both designs are likely to work in clinical practice, they are different.

Aims

The aim of this study was to compare the design of the generic OptiStem XTR femoral stem with the established Exeter femoral stem.