The goal of this prospective, randomised controlled trial is to compare outcomes after a BIOPRO® hemi prosthesis or a modified Keller resection arthroplasty for the treatment of hsymptomatic hallux rigidus patients.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient satisfaction, pain, function, AOFAS score, FAOS questionnaire,
radiographic evaluation, complications.
Secondary outcome
n.a.
Background summary
Hallux rigidus is characterized by a rigid and often painful first
metatarsophalangeal (FMTP) joint due to degenerative changes within the joint.
Widely used surgical procedures for the management of hallux rigidus are
cheilectomy, Keller resection arthroplasty, arthrodesis of the FMTP joint and a
prosthesis. With total joint replacement, pain can be reduced and function can
be restored. However, many complications, such as waer, osteolysis, foreign
body reaction and loosening or displacement of the components, are seen due to
great (shear) forces during gait.
The BIOPRO® resurfacing endoprosthesis has been used for many years now, but
because of lack of prospective, randomised controlled trials describing
outcomes after metallic hemi prosthesis of the proximal phalanx, this study is
designed.
Study objective
The goal of this prospective, randomised controlled trial is to compare
outcomes after a BIOPRO® hemi prosthesis or a modified Keller resection
arthroplasty for the treatment of hsymptomatic hallux rigidus patients.
Study design
The patients included in this study will be selected at random to one of the
two groups. One group will be treated with a BIOPRO® hemi prosthesis, the other
group will be treated by a Keller procedure.
Intervention
Operative treatment with either a BIOPRO® hemi prosthesis or a Keller resection
arthroplasty.
Study burden and risks
Patients have the same risks and burden compared to patients not included in
the study, except for the questionnaire during pre- and postoperative visits.
Walramstraat 23
6131 BK Sittard
Nederland
Walramstraat 23
6131 BK Sittard
Nederland
Listed location countries
Age
Inclusion criteria
1) hallux rigidus
2) painful FMTP joint
Exclusion criteria
1) hallux valgus or hallux valgus et rigidus
2) patients suffering rheumatoid arthritis
3) (previous) FMTP joint infection
4) severe neurovascular compromised patients
5) metatarsalgia
Design
Recruitment
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 | NL14920.096.06 |