Long term follow up after rotationplasty

The rotationplasty was first described (1930) by Borgreve as a treatment option
for tuberculosis of the knee joint and popularized (1950) by van Nes to treat
congenital femoral defects. Subsequently, this surgical technique was
introduced in the treatment of osteosarcomas, as an alternative for above-knee
amputations. A major advantage of rotationplasty compared to above-knee
amputation is preservation of knee function with a better functional outcome,
while maintaining surgical margins around the tumor. Further, complication
rates after rotationplasty are low and additional surgeries exceptional.
Rotationplasty does not result in a normal knee, but on short-term it allows
higher walking speed, better gait, lower oxygen consumption and improved
general efficiency compared to above-knee amputation or arthrodesis. As a
consequence of these favorable factors, patients can participate in various
sport activities. On the other hand, concerns were expressed about psychosocial
consequences of the mutilating appearance of the rotated and shortened leg.
Previous research did not confirm these expected adverse psychosocial effects.
As a result of improved limb-sparing techniques within orthopedic oncology,
such as endoprostetic replacements, auto- or allografts and combinations of
these procedures, nowadays rotationplasty is rarely used. Rotationplasty is
still indicated when limb-sparing surgery is not feasible after resection of a
malignant bone tumor about the knee joint, or as a reconstruction modality to
avoid more extensive amputation after a failed limb-salvage procedures. A
similar functional outcome was found after endoprostetic reconstruction and
rotationplasty, however patients with an endoprothesis might lead a more
sedentary life due to fear of destroying the endoprothesis.
Rotationplasty has proven to be an effective, highly functional option in
short- and mid-term studies. However, little is known on the long-term impact
of life about this invasive procedure. The limited available information are
small case series or case reports with a mean follow up of mostly 15-20 years.
The main objectives of this cohort study, are to assess the long-term
health-related quality of life, and physical and functional outcomes of
patients after an rotationplasty, using a combination of self-administered
questionnaires, physical examination, evaluation of osteoarthritis, and walking
tests. Insights into these long-term outcomes are needed to better inform (new)
patients about the consequences of rotationplasty and may change future
procedures in favor or against this orphan surgical procedure.

Primary Objective:
To asses health-related quality of life and functional outcome after long-term
follow up, in patients treated with a rotationplasty for primary malignant bone
tumours or PFFD compared to above-knee amputation means.

Secondary Objective(s):
· To evaluate factors affecting health-related quality of life, occupation and
sport activities with regard to the performed rotationplasty.
· To measure self-reported activity limitations of these patients by
questionnaire*s and satisfaction with their external prosthesis. And to further
objectify activity limitations after rotationplasty, as measured by gait
biomechanics, walking speed and walking energy cost.
· Furthermore, impairments will be revealed by physical examination of hips,
knee and ankles objectified by development of osteoarthritis on plain
radiographs.

The outcomes with respect to gait biomechanics and walking energy cost can be
compared to healthy reference values, but also to the values of patients with
above-knee amputations. Measured joint angles and joint moments of the affected
leg (rotationplasty) can be compared to the contralateral side and to general
population means. This can provide insight into compensation mechanisms of the
control lateral leg and into fall risk. Furthermore, osteoarthritis on
performed radiographs can be related to joint loading during walking.

The study design is a cross-sectional follow-up study. All patient records of
consecutive patients who had an arthroplasty between 1980-2005 at the Academic
Medical Center (AMC) or *Onze Lieve Vrouwe Gasthuis* (OLVG) in Amsterdam are
checked. We will score both deceased patients and survivors. Survivors
(approximately N=30-50) will be approached to take part on this study by phone
followed by a letter explaining the study including an informed consent. The
participants can either fill out the self-reported questionnaires (SF 36, TESS,
PEQ, VAS, AOS, FAOS and social-/ prosthesis related questions) at home through
internet (using Castor Electronic Data Capture) or on paper at the outpatient
clinic.

The participants will visit the outpatient clinic to undergo a physical
examination (hips, knee- and ankle function) and get plain radiographs of the
formal ankle joint, now functioning as a knee (including the contralateral
ankle to compare with) and of the pelvis (to compare osteoarthritis development
of both hips). If they did not fill out computer based questionnaires at home,
they can to do that during their one time visit at the outpatient clinic. This
part of the study will be performed at the department of orthopaedic surgery of
the AMC in Amsterdam, the Netherlands. When possible during the same visit,
patients undergo a 3D gait analysis and 6-minute walking energy cost test
performed at the department of rehabilitation of the AMC in Amsterdam, the
Netherlands.
The duration of the study depends on the time needed for data collection,
probably several months up to a year.

Both patients and controls will be asked to visit the Amsterdam AMC maximal two
times to participate in the explained measurements.
The risks are negligible (plain radiograph) and the burden minimal (time coming
to the hospital to answer the health-related quality of life questions (1
hour), to undergo a physical examination (30 minutes), a 6-minute walk test (30
minutes) and a 3D gait analysis (75 minutes)).
The study can only be done using these specific patients groups, because it is
a rare disease and very rare surgical treatment.
The measurements are non-invasive. There will be no costs related to the study
components. Traveling costs for the visits will be reimbursed by the research
project. Questionnaires can be completed during the visit or by e-mail using
*CASTOR EDC*

Potential risks:
Possible risks related to all study parts are considered minimal.
During the gait analysis and 6-minute walk test, patients walk on an obstacle
free indoor track, and risks of falling are considered minimal. Patients can
get tired during these tests (6MWT and 3DGA), however it is ensured that they
receive enough recovery time during and in between tests.

Potential benefits:
Participants get the chance to receive more insight in their functionality and
their external prosthesis is being checked by experts in the field. Also, they
get the opportunity to express dissatisfaction and might come up with solutions
to immediately improve their own quality of life.