None listed
Conditions
Brief summary
The purpose is to determine if it is better (or worse) to include the carpometacarpal joint in total wrist fusion. The carpometacarpal joint (CMC) doesn’t move much in a normal wrist. It is located at the base of the metacarpals which are bones located between the wrist bones and fingers. If the carpometacarpal joint is fused in total wrist fusion, the third carpometacarpal joint (at the base of the long finger metacarpal) is usually fused. Sometimes the second carpometacarpal joint (base of the index finger) is fused if a slightly different position of the wrist is required. We do not yet know if fusing the CMC joint (or not) during wrist fusion leads to better patient outcomes. Currently, some surgeons prefer to fuse this joint as they think it may become painful later and that motion at this joint may cause the metal plates used in wrist fusion to break. Previous research on this question has shown there is no difference in outcome in patients who have or have not have this joint fused during total wrist fusion. However, these studies were small and were not properly designed to answer this question. For this reason, we would like to complete a properly designed study to determine what approach leads to the best outcomes. We seek to compared the two 'gold standards' of wrist arthrodesis in a randomised way - wrist fusion with inclusion of the CMCJ with a plate that goes across this joint to wrist fusion without CMCJ fusion with a plate that does not cross this joint. The results of this study will inform future patients and surgeons of the best option.
Interventions
This randomised control trial will scrutinise wrist arthrodesis with carpometacarpal joint (CMCJ) fusion using a CMCJ spanning plate compared to wrist arthrodesis without CMCJ fusion with a non-spanning CMCJ plate. The population assessed will be adults with isolated wrist arthritis awaiting total arthrodesis of the wrist. After consent and randomisation they will undergo total wrist arthrodesis with the Synthes DePuy/AO wrist arthrodesis plate (CMCJ spanning plate) with CMCJ fusion or total wri
This randomised control trial will scrutinise wrist arthrodesis with carpometacarpal joint (CMCJ) fusion using a CMCJ spanning plate compared to wrist arthrodesis without CMCJ fusion with a non-spanning CMCJ plate. The population assessed will be adults with isolated wrist arthritis awaiting total arthrodesis of the wrist. After consent and randomisation they will undergo total wrist arthrodesis with the Synthes DePuy/AO wrist arthrodesis plate (CMCJ spanning plate) with CMCJ fusion or total wrist arthrodesis with the Medartis APTUS Trilock (CMCJ non-spanning plate) without CMCJ fusion. Surgery will be undertaken by a fellowship trained orthopaedic surgeon specialising in hand and wrist surgery. Bone graft from local or other sources will be permitted. The duration of surgery will not differ between treatment and control groups. An observer will ensure that participants are treated according to allocation. The populations will be compared at 1, 2 and 5 years for complications. Secondary outcomes will include assessment of disability with the Disabilities of the Arm Shoulder and Hand (DASH) score, Patient Rate Wrist Evaluation (PRWE) and grip strength. Control group (CMCJ arthrodesis) The radiocarpal, intercarpal AND the CMCJ will be prepared for fusion in the group undergoing CMCJ arthrodesis. A CMCJ bridging plate will be applied (Synthes DePuy/AO Wrist fusion plate) from the third metacarpal to the radius as described by the manufacturer’s instructions. Intervention group (CMCJ sparing) During surgery the CMCJ will be identified and carefully preserved in the CMCJ sparing arm. After preparing the carpals for fusion, while carefully preserving CMCJ joint and its capsule, a non-spanning wrist fusion plate will be applied according the manufactures description (Medartis AG, Switzerland).
Sponsors
Trauma and Orthopaedic Research Unit Canberra Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
This study will include English speaking, non-institutionalized individuals aged > 18 years deemed suitable for total wrist arthrodesis by their surgeon, with non-inflammatory indications for surgery including: SNAC (Scaphoid non-union advanced collapse) SLAC (Scapholunate ligament advanced collapse) Keinbock’s disease/Lunate avascular necrosis Preiser’s disease/Scaphoid avascular necrosis Wrist osteoarthritis Post traumatic arthritis Failed partial fusion
Exclusion criteria
Patients will be excluded from this study if: Lack ability to consent for participation (cognitive capacity or English proficiency) Lack ability to report patient outcomes measures (cognitive capacity or English proficiency) Have an inflammatory arthropathy (i.e., Rheumatoid arthritis) Have pre-existing upper ipsilateral or contralateral limb pain or dysfunction Brain, nerve or muscle dysfunction (CVA, plexus injury, peripheral nerve injury, spasm or contracture) Tumour of the wrist (giant cell or other) Wrist arthroplasty that will be revised to arthrodesis Planned to undergo or have undergone bilateral wrist arthrodesis
Outcome results
None listed