The aim of this prospective, multicenter, trial is 1) to describe the effect of a suprapatellar approach on anterior knee pain, and 2) to assess the effect of a transverse versus a longitudinal transpatellar incision on anterior knee pain.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure for the randomized trial is the difference in kneeling
pain based on a numeric rating scale (NRS) at 12 months post-surgery between
patients treated with a longitudinal and a transverse incision.
Secondary outcome
Secondary outcome measures for the randomized trial (transverse versus
longitudinal incision) include differences at 12 months post-surgery between
both groups for knee pain during daily activities, infrapatellar nerve injury,
functional outcome and health care consumption. Outcome measures for the cohort
study (suprapatellar approach) include all above mentioned parameters.
Background summary
Anterior knee pain is a common complaint after intramedullary nailing of the
tibia. Iatrogenic injury to the infrapatellar nerve is thought to be a
contributing cause in the trans- and parapatellar approach. The recently
introduced suprapatellar approach has proven feasible, but only limited data
exists on its effect on knee pain. We hypothesize that anterior knee pain after
tibial nailing can be reduced by decreasing the risk of infrapatellar nerve
injury.
Study objective
The aim of this prospective, multicenter, trial is 1) to describe the effect of
a suprapatellar approach on anterior knee pain, and 2) to assess the effect of
a transverse versus a longitudinal transpatellar incision on anterior knee
pain.
Study design
The study is divided in two parts. Part A (cohort): patients will be treated
with a suprapatellar approach if the fracture is suitable for this technique
and if the treating surgeon is familiar with it. Few patients are expected to
be treated using this approach and therefore will be analysed separately. Part
B (randomized trial): all other eligible patients will be treated with the
transpatellar approach and will be equally randomized to a longitudinal or
transverse incision. A total of 120 patients will be included in Part B.
Intervention
Patients treated with a transpatellar approach will be equally randomized to a
longitudinal or transverse incision.
Study burden and risks
All patients will be reviewed at the outpatient clinic by the treating surgeon
and a research assistant at 2 weeks post-surgery and at 6 weeks, 3, 6 and 12
months post-surgery. Depending on the time since surgery the time-specific
questionnaires will be completed (one pain questionnaire, two functional
outcome questionnaires, one questionnaire about general well-being and one
about healthcare consumption). Radiographs are a standard of care and will be
taken before every visit in order to check nail position and radiographic
union. Except for a possible diminished chance of anterior knee pain in the
transverse group no benefits are expected for participants. No extra risks are
accounted for when participating in this study. A large proportion of tibia
shaft fractures is due to sports (soccer) and traffic accidents (scooter,
bicycle etc). This group is mainly represented by young males. Therefore this
specific age group (16-17) is included in the study.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Age between 16 and 65 years
Unilateral tibial shaft fracture (AO 42 A, B and C)
Indication for intramedullary nailing in judgement of the treating surgeon (within 2 weeks after initial trauma)
Provided written informed consent by patient
Exclusion criteria
Gustilo open fractures grade III-C or open wound on knee
Polytrauma patients, when concurring injury affect treatment and recovery
Patients with bilateral tibial shaft fractures
Patients with a pathological or recurrent fracture of the tibia
Patients with pre-existing knee pathology (e.g. menisci, cruciate ligament)
Patients with pre-existing functional impairment which has influence on rehabilitation (e.g. wheelchair-bound)
Patients with rheumatoid arthritis
Patients with bone disease resulting in delayed union (except osteoporosis)
Insufficient comprehension of Dutch language to adhere to treatment guidelines
Likely problems with follow-up (e.g. no fixed address)
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 | NL49144.078.14 |