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ID
Source
Brief title
Health condition
Carpometacarpal osteoarthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients will evaluated pre-operatively, and postoperatively at 6 weeks, 3, 12 and 24 months.
Our primary outcome measure for pain and physical function is the patient rated wrist/hand evaluation (PRWHE) (Dutch Language Version) questionnaire (0=no pain and able to do activities – 100 = worst pain an unable to do activities). (20) The PRWHE is a wrist and hand specific questionnaire with items about the affected wrist and hand alone. A report of MacDermid and Tottenham showed that the PRWHE questionnaire is more responsive in detecting clinical changes over time compared to the DASH. (21)
Secondary outcome
At 12 months follow-up a patient global assessment will be performed by asking the patients about overall satisfaction (0 = completely dissatisfied, 10 = completely satisfied) if he or she would have the same surgery again under the same circumstances. Furthermore, we will register how many weeks after surgery patients returned to work or normal daily life activities.
All complications after surgery will be registered for a period of 12 months. Complications will be divided in 3 categories: (1) mild, (2) moderate, and (3) severe. Mild complications are defined as complications with a minor clinical relevance, such as scar tenderness, superficial infection requiring antibiotics or transient sensory disturbances. We define moderate complications as clinical relevant complications that were delaying patients’ recovery, but not needing revision surgery and that were resolved 12 months after surgery. Examples are deep infections requiring antibiotics for more than a week and wound dehiscence. Severe complications are defined as complications that resulted in revision surgery, pain at rest or impaired hand function at the 12-month examination. Examples: persistent pain compared to the preoperative situation, CRPS type I, and neuroma’s
Additionally, we will evaluate the following active palmar abduction of the thumb using the Pollexograph. Furthermore, CMC joint opposition was measured using the Kapandji score (1 to 10: 1 = the thumb reaches the lateral side of the second phalanx of the index finger, 10 = the thumb reaches the distal volar crease of the hand). The strength measurements will consist of: tip pinch strength and key pinch strength measured using a baseline pinch gauge (Biometrics Ltd E-link H500 Hand Kit; Gwent, UK). Grip strength will be measured using a baseline hydraulic hand dynamometer (Biometrics Ltd E-link H500 Hand Kit). The mean of three measurements will be recorded as an outcome variable. All active ROM and strength measurements are performed by independent and blinded hand therapists in accordance with a strict, well defined, published protocol.
Sensation on the dorsum of the thumb will be measured with normal touch to the dorsum of the IP joint of the thumb and the MP joint of the index finger and compared to the non-operated hand. The touch was measured as normal, absent or abnormal (for example hypoesthesia or hyperesthesia)
Background summary
Arthroscopic distal hemitrapeziectomy versus open hemitrapeziectomy without interposition in osteoarthritis of the first CMC joint
Study objective
We hypothesize that compared to open surgery, arthroscopic intervention results in:
1. earlier postoperative functional recovery
2. Less chance of damaging the superficial branch of the radial nerve
3. Less postoperative pain
Study design
6 weeks, 3, 12 and 24 months
Intervention
1. Arthroscopic hemitrapeziectomy
The procedure is performed under regional or general anaesthesia. Tourniquet control is applied, the thumb held in longitudinal traction. Traction applied to the thumb is 3-5 kg. The CMC joint is identified with palpation and a needle insertion. Small incisions are made on the radial and ulnar side (1U and 1R [ref]) of the EPB. With small scissors and blunt clamp the joint capsule is perforated and the 1.9 mm or 2.3 mm 30 degrees arthroscope is introduced. After identification, the joint is debrided and a synovectomy is performed using the 2.3 shaver. The hemitrapeziectomy is performed with the burr (2.6 or 3.9 mm), debriding the sclerosed surface of the distal trapezium for about two to three mm. The instruments and arthroscope are changed from portals to achieve adequate resection. Debris is rinsed out and the instruments are removed.
2. Open trapeziectomy
The procedure is performed under regional or general anaesthesia. Tourniquet control is applied, with the arm on an arm rest. According to the surgeon a volar Wagner incision or a dorsal incision is made. Branches of the superficial radial nerve are identified and retracted. The CMC joint is opened, hereby creating a capsule flap which is closed at the end of the procedure. The trapezium is removed using an oscillating saw, osteotome and rongeur in a piecemeal technique. Special attention is given to osteophytes around the CMC I joint (if present, between first and second metacarpal). Care is given not to damage the FCR tendon. Afterwards debris is rinsed out and the capsule is closed with resorbable braided sutures. Skin is closed with nonabsorbable nylon suture.
Rehabilitation
In both groups, directly postoperatively, the thumb is immobilised in a fore arm splint, with only the interphalangeal joint free to move. The splint is changed at the first outpatient visit two weeks later and a thumb spica cast is applied for an additional four weeks. After removal of the cast a hand therapy regime is started and full motion is allowed. Full power and sport can be a resumed at 12 weeks postoperative.
Inclusion criteria
1. Painful CMC osteoarthritis of thumb
2. Type II and III according to Eaton’s Classification on x-ray
3. Minimum of 3 months nonsurgical treatment (NSAID, intra-articular injections, and splinting)
Exclusion criteria
1. STT osteoarthritis (type 4 on Eaton’s classification)
2. Hyperlaxity (syndromes)
3. Systemic degenerative poly or panarthritis (RA, gout, psoriasis)
4. Subluxation >1/2 of the joint surface (indication for reconstruction of the volar beak ligament)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7918 |
| CCMO | NL44294.078.13 |
| OMON | NL-OMON40183 |