The primary objective of this study is to evaluate the feasibility of performing Superpath® in the Reinier de Graaf Hospital in Delft.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective is the feasibility of the Superpath technique:
Feasibility will evaluated by the length of the operation, placement of the
implants and blood loss during the individual procedure. 2 of the 3 criteria
must be met, in order to consider the surgery successful. Furthermore, if in
80% or more of the surgeries intra-operative complications (lesion of the n.
Ischiadicus or a fissura of the femur) occur, the SuperPath procedure is not
feasible.
- Surgery time for a primary total hip arthroplasty using SuperPath® may not
exceed 2.5 hours.
- For the acetabular implant 20 to 60 degrees of inclination and 15 degrees of
anteversion is accepted. The femoral implant should be placed straight in the
femoral shaft and the hip rotation center should be restored anatomically
- The average amount of bloodloss performing total hip arthroplasty with
SuperPath® may not exceed 1000 cc.
Secondary outcome
Outcome will be clinically measured using the HOOS-PS, EQ5-D, OHS, HHS, NRS and
satisfaction whilst radiographic outcomes will be evaluated through standard
radiographic parameters. The amount of bloodloss and length of surgery will be
noted. Complications will be registered as well.
Background summary
Cementless total hip arthroplasty (THA) has very good clinical results. As a
result of the success, the ageing population and because the procedure is
performed in increasingly younger and more active patients, the number of THA
procedures has increased the last decades. Long term results of THA are well
documented. But patient speed of recovery and return to activities is thought
to be affected by the surgical technique used. The supercapsular
percutaneously-assisted total hip (SuperPath®) surgical technique (MicroPort
Orthopedics Inc., Arlington, TN, USA) is a relatively new technique and
combines aspects of the SuperCap® and PATH® surgical techniques. The advantage
of SuperPath is the tissue sparing aspect of the surgical approach. In all
other THA techniques access to the hip capsule is performed by cutting parts of
the jointcapsule, tendons or muscles. In SuperPath® only the jointcapsule is
incised and the surrounding soft tissue is respected. This surgical technique
does not require any special operative tables or the forced dislocation of the
femoral head. The approach utilizes the tissue space between the gluteus medius
and the piriformis to access the capsule without releasing the conjoint tendons
or external rotator muscles
Early results of this surgical technique are promising. Superpath® seems to
shorter length of stay (LOS), more patients can leave the hospital the day of
the operation and the 30-day readmission rate is reduced. Also in-hospital
costs for total hip replacement performed using the Superpath® technique are
reduced (5).
Study objective
The primary objective of this study is to evaluate the feasibility of
performing Superpath® in the Reinier de Graaf Hospital in Delft.
Study design
A prospective clinical trial in which 10 cases will be enrolled over one
hospital. Patients will be evaluated preoperatively and postoperatively at 6
weeks.
Intervention
Placement of the Profemur Tl classic stem and Procotyl cup with SuperPath®
technique
Study burden and risks
Subjects participating in the study have the same risks and benefits when not
participating in the study. All components used in the study have CE mark and
are already in use.
Toneellaan 2
Zoetermeer 2725 NA
NL
Toneellaan 2
Zoetermeer 2725 NA
NL
Listed location countries
Age
Inclusion criteria
•Patient is 18 to 75 years of age, inclusive
•Patient is able to speak and write Dutch
•Patient qualifies for primary unilateral total hip arthroplasty
(THA) based on physical exam and medical history including at least one of
the following:
o Osteoarthritis
o Avascular necrosis (AVN)
o Inflammatory arthritis
o Rheumatoid arthritis with adequate bone quality
o Post-traumatic arthritis
o Congenital hip dysplasia., •Patient has no history of previous total hip
replacement or arthrodesis of the affected hip
joint(s).
• Patient is willing and able to provide written informed consent.
Exclusion criteria
Subjects will be excluded when they meet one or more of the following
contra-indications for the SuperPath® technique:
• Infection, sepsis, and osteomyelitis
• Patients with a low femoral offset
• Uncooperative patient or patient with neurologic disorders who are incapable
of following directions
• Insufficient bone stock to provide adequate support and/or fixation to the
prosthesis
• Metabolic disorders which may impair bone formation
• Osteomalacia
• Distant foci of infections which may spread to the implant site
• Rapid joint destruction, marked bone loss or bone resorption apparent on
roentgenogram
• Vascular insufficiency, muscular atrophy, neuromuscular disease ,
Additionally, subjects will be excluded when they meet the following exlusion
criteria:
• Patients with emergency or semi-emergency THA (e.g. for treatment of femoral
neck fractures)
• Patient has a known or suspected sensitivity or allergy to one or more of the
implant materials
• Revision THA surgery of the ipsilateral side
• Contralateral THA <6 months before current surgery
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65358.098.18 |